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116th Congress   }                                   {    Rept. 116-55
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                   {          Part 1

======================================================================



 
 CREATING AND RESTORING EQUAL ACCESS TO EQUIVALENT SAMPLES ACT OF 2019

                                _______
                                

                  May 10, 2019.--Ordered to be printed

                                _______
                                

        Mr. Pallone, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 965]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 965) to promote competition in the market for 
drugs and biological products by facilitating the timely entry 
of lower-cost generic and biosimilar versions of those drugs 
and biological products, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     6
Background and Need for the Legislation..........................     6
Committee Hearings...............................................     7
Committee Consideration..........................................     7
Committee Votes..................................................     8
Oversight Findings...............................................    10
New Budget Authority, Entitlement Authority, and Tax Expenditures    10
Congressional Budget Office Estimate.............................    10
Federal Mandates Statement.......................................    13
Statement of General Performance Goals and Objectives............    13
Duplication of Federal Programs..................................    13
Committee Cost Estimate..........................................    13
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......    13
Advisory Committee Statement.....................................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    16

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Creating and Restoring Equal Access to 
Equivalent Samples Act of 2019'' or the ``CREATES Act of 2019''.

SEC. 2. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL 
                    PRODUCTS.

  (a) Definitions.--In this section--
          (1) the term ``commercially reasonable, market-based terms'' 
        means--
                  (A) a nondiscriminatory price for the sale of the 
                covered product at or below, but not greater than, the 
                most recent wholesale acquisition cost for the drug, as 
                defined in section 1847A(c)(6)(B) of the Social 
                Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
                  (B) a schedule for delivery that results in the 
                transfer of the covered product to the eligible product 
                developer consistent with the timing under subsection 
                (b)(2)(A)(iv); and
                  (C) no additional conditions are imposed on the sale 
                of the covered product;
          (2) the term ``covered product''--
                  (A) means--
                          (i) any drug approved under subsection (c) or 
                        (j) of section 505 of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 355) or biological 
                        product licensed under subsection (a) or (k) of 
                        section 351 of the Public Health Service Act 
                        (42 U.S.C. 262);
                          (ii) any combination of a drug or biological 
                        product described in clause (i); or
                          (iii) when reasonably necessary to support 
                        approval of an application under section 505 of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355), or section 351 of the Public 
                        Health Service Act (42 U.S.C. 262), as 
                        applicable, or otherwise meet the requirements 
                        for approval under either such section, any 
                        product, including any device, that is marketed 
                        or intended for use with such a drug or 
                        biological product; and
                  (B) does not include any drug or biological product 
                that appears on the drug shortage list in effect under 
                section 506E of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 356e), unless--
                          (i) the drug or biological product has been 
                        on the drug shortage list in effect under such 
                        section 506E continuously for more than 6 
                        months; or
                          (ii) the Secretary determines that inclusion 
                        of the drug or biological product as a covered 
                        product is likely to contribute to alleviating 
                        or preventing a shortage.
          (3) the term ``device'' has the meaning given the term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321);
          (4) the term ``eligible product developer'' means a person 
        that seeks to develop a product for approval pursuant to an 
        application for approval under subsection (b)(2) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or for licensing pursuant to an application under 
        section 351(k) of the Public Health Service Act (42 U.S.C. 
        262(k));
          (5) the term ``license holder'' means the holder of an 
        application approved under subsection (c) or (j) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
        the holder of a license under subsection (a) or (k) of section 
        351 of the Public Health Service Act (42 U.S.C. 262) for a 
        covered product;
          (6) the term ``REMS'' means a risk evaluation and mitigation 
        strategy under section 505-1 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355-1);
          (7) the term ``REMS with ETASU'' means a REMS that contains 
        elements to assure safe use under section 505-1(f) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
          (8) the term ``Secretary'' means the Secretary of Health and 
        Human Services;
          (9) the term ``single, shared system of elements to assure 
        safe use'' means a single, shared system of elements to assure 
        safe use under section 505-1(f) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355-1(f)); and
          (10) the term ``sufficient quantities'' means an amount of a 
        covered product that the eligible product developer determines 
        allows it to--
                  (A) conduct testing to support an application under--
                          (i) subsection (b)(2) or (j) of section 505 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355); or
                          (ii) section 351(k) of the Public Health 
                        Service Act (42 U.S.C. 262(k)); and
                  (B) fulfill any regulatory requirements relating to 
                approval of such an application.
  (b) Civil Action for Failure To Provide Sufficient Quantities of a 
Covered Product.--
          (1) In general.--An eligible product developer may bring a 
        civil action against the license holder for a covered product 
        seeking relief under this subsection in an appropriate district 
        court of the United States alleging that the license holder has 
        declined to provide sufficient quantities of the covered 
        product to the eligible product developer on commercially 
        reasonable, market-based terms.
          (2) Elements.--
                  (A) In general.--To prevail in a civil action brought 
                under paragraph (1), an eligible product developer 
                shall prove, by a preponderance of the evidence--
                          (i) that--
                                  (I) the covered product is not 
                                subject to a REMS with ETASU; or
                                  (II) if the covered product is 
                                subject to a REMS with ETASU--
                                          (aa) the eligible product 
                                        developer has obtained a 
                                        covered product authorization 
                                        from the Secretary in 
                                        accordance with subparagraph 
                                        (B); and
                                          (bb) the eligible product 
                                        developer has provided a copy 
                                        of the covered product 
                                        authorization to the license 
                                        holder;
                          (ii) that, as of the date on which the civil 
                        action is filed, the product developer has not 
                        obtained sufficient quantities of the covered 
                        product on commercially reasonable, market-
                        based terms;
                          (iii) that the eligible product developer has 
                        requested to purchase sufficient quantities of 
                        the covered product from the license holder; 
                        and
                          (iv) that the license holder has not 
                        delivered to the eligible product developer 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms--
                                  (I) for a covered product that is not 
                                subject to a REMS with ETASU, by the 
                                date that is 31 days after the date on 
                                which the license holder received the 
                                request for the covered product; and
                                  (II) for a covered product that is 
                                subject to a REMS with ETASU, by 31 
                                days after the later of--
                                          (aa) the date on which the 
                                        license holder received the 
                                        request for the covered 
                                        product; or
                                          (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        subparagraph (B).
                  (B) Authorization for covered product subject to a 
                rems with etasu.--
                          (i) Request.--An eligible product developer 
                        may submit to the Secretary a written request 
                        for the eligible product developer to be 
                        authorized to obtain sufficient quantities of 
                        an individual covered product subject to a REMS 
                        with ETASU.
                          (ii) Authorization.--Not later than 120 days 
                        after the date on which a request under clause 
                        (i) is received, the Secretary shall, by 
                        written notice, authorize the eligible product 
                        developer to obtain sufficient quantities of an 
                        individual covered product subject to a REMS 
                        with ETASU for purposes of--
                                  (I) development and testing that does 
                                not involve human clinical trials, if 
                                the eligible product developer has 
                                agreed to comply with any conditions 
                                the Secretary determines necessary; or
                                  (II) development and testing that 
                                involves human clinical trials, if the 
                                eligible product developer has--
                                          (aa)(AA) submitted protocols, 
                                        informed consent documents, and 
                                        informational materials for 
                                        testing that include 
                                        protections that provide safety 
                                        protections comparable to those 
                                        provided by the REMS for the 
                                        covered product; or
                                          (BB) otherwise satisfied the 
                                        Secretary that such protections 
                                        will be provided; and
                                          (bb) met any other 
                                        requirements the Secretary may 
                                        establish.
                          (iii) Notice.--A covered product 
                        authorization issued under this subparagraph 
                        shall state that the provision of the covered 
                        product by the license holder under the terms 
                        of the authorization will not be a violation of 
                        the REMS for the covered product.
          (3) Affirmative defense.--In a civil action brought under 
        paragraph (1), it shall be an affirmative defense, on which the 
        defendant has the burden of persuasion by a preponderance of 
        the evidence--
                  (A) that, on the date on which the eligible product 
                developer requested to purchase sufficient quantities 
                of the covered product from the license holder--
                          (i) neither the license holder nor any of its 
                        agents, wholesalers, or distributors was 
                        engaged in the manufacturing or commercial 
                        marketing of the covered product; and
                          (ii) neither the license holder nor any of 
                        its agents, wholesalers, or distributors 
                        otherwise had access to inventory of the 
                        covered product to supply to the eligible 
                        product developer on commercially reasonable, 
                        market-based terms;
                  (B) that--
                          (i) the license holder sells the covered 
                        product through agents, distributors, or 
                        wholesalers;
                          (ii) the license holder has placed no 
                        restrictions, explicit or implicit, on its 
                        agents, distributors, or wholesalers to sell 
                        covered products to eligible product 
                        developers; and
                          (iii) the covered product can be purchased by 
                        the eligible product developer in sufficient 
                        quantities on commercially reasonable, market-
                        based terms from the agents, distributors, or 
                        wholesalers of the license holder; or
                  (C) that the license holder made an offer to sell 
                sufficient quantities of the covered product to the 
                eligible product developer at commercially reasonable 
                market-based terms--
                          (i) for a covered product that is not subject 
                        to a REMS with ETASU, by the date that is 14 
                        days after the date on which the license holder 
                        received the request for the covered product, 
                        and the eligible product developer did not 
                        accept such offer by the date that is 7 days 
                        after the date on which the eligible product 
                        developer received such offer from the license 
                        holder; or
                          (ii) for a covered product that is subject to 
                        a REMS with ETASU, by the date that is 20 days 
                        after the date on which the license holder 
                        received the request for the covered product, 
                        and the eligible product developer did not 
                        accept such offer by the date that is 10 days 
                        after the date on which the eligible product 
                        developer received such offer from the license 
                        holder.
          (4) Methods for transmission of requests for covered 
        products.--A written request for a covered product, offer to 
        sell a covered product, or acceptance of such an offer between 
        the eligible product developer and the license holder shall be 
        made by--
                  (A) certified or registered mail with return receipt 
                requested;
                  (B) personal delivery; or
                  (C) electronic means.
          (5) Remedies.--
                  (A) In general.--If an eligible product developer 
                prevails in a civil action brought under paragraph (1), 
                the court shall--
                          (i) order the license holder to provide to 
                        the eligible product developer without delay 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms;
                          (ii) award to the eligible product developer 
                        reasonable attorney's fees and costs of the 
                        civil action; and
                          (iii) award to the eligible product developer 
                        a monetary amount sufficient to deter the 
                        license holder from failing to provide eligible 
                        product developers with sufficient quantities 
                        of a covered product on commercially 
                        reasonable, market-based terms, if the court 
                        finds, by a preponderance of the evidence--
                                  (I) that the license holder delayed 
                                providing sufficient quantities of the 
                                covered product to the eligible product 
                                developer without a legitimate business 
                                justification; or
                                  (II) that the license holder failed 
                                to comply with an order issued under 
                                clause (i).
                  (B) Maximum monetary amount.--A monetary amount 
                awarded under subparagraph (A)(iii) shall not be 
                greater than the revenue that the license holder earned 
                on the covered product during the period--
                          (i) beginning on--
                                  (I) for a covered product that is not 
                                subject to a REMS with ETASU, the date 
                                that is 31 days after the date on which 
                                the license holder received the 
                                request; or
                                  (II) for a covered product that is 
                                subject to a REMS with ETASU, the date 
                                that is 31 days after the later of--
                                          (aa) the date on which the 
                                        license holder received the 
                                        request; or
                                          (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        paragraph (2)(B); and
                          (ii) ending on the date on which the eligible 
                        product developer received sufficient 
                        quantities of the covered product.
                  (C) Avoidance of delay.--The court may issue an order 
                under subparagraph (A)(i) before conducting further 
                proceedings that may be necessary to determine whether 
                the eligible product developer is entitled to an award 
                under clause (ii) or (iii) of subparagraph (A), or the 
                amount of any such award.
  (c) Limitation of Liability.--A license holder for a covered product 
shall not be liable for any claim under Federal, State, or local law 
arising out of the failure of an eligible product developer to follow 
adequate safeguards to assure safe use of the covered product during 
development or testing activities described in this section, including 
transportation, handling, use, or disposal of the covered product by 
the eligible product developer.
  (d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the 
following new subsection:
  ``(l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product to an eligible product 
developer (as those terms are defined in section 2(a) of the Creating 
and Restoring Equal Access to Equivalent Samples Act of 2019) shall not 
be considered a violation of the requirements of any risk evaluation 
and mitigation strategy that may be in place under this section for 
such drug.''.
  (e) Rule of Construction.--
          (1) Definition.--In this subsection, the term ``antitrust 
        laws''--
                  (A) has the meaning given the term in subsection (a) 
                of the first section of the Clayton Act (15 U.S.C. 12); 
                and
                  (B) includes section 5 of the Federal Trade 
                Commission Act (15 U.S.C. 45) to the extent that such 
                section applies to unfair methods of competition.
          (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of the 
        antitrust laws.

SEC. 3. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.

  Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355-1), as amended by section 2, is further amended--
          (1) in subsection (g)(4)(B)--
                  (A) in clause (i) by striking ``or'' after the 
                semicolon;
                  (B) in clause (ii) by striking the period at the end 
                and inserting ``; or''; and
                  (C) by adding at the end the following:
                          ``(iii) accommodate different, comparable 
                        aspects of the elements to assure safe use for 
                        a drug that is the subject of an application 
                        under section 505(j), and the applicable listed 
                        drug.'';
          (2) in subsection (i)(1), by striking subparagraph (C) and 
        inserting the following:
                  ``(C)(i) Elements to assure safe use, if required 
                under subsection (f) for the listed drug, which, 
                subject to clause (ii), for a drug that is the subject 
                of an application under section 505(j) may use--
                          ``(I) a single, shared system with the listed 
                        drug under subsection (f); or
                          ``(II) a different, comparable aspect of the 
                        elements to assure safe use under subsection 
                        (f).
                  ``(ii) The Secretary may require a drug that is the 
                subject of an application under section 505(j) and the 
                listed drug to use a single, shared system under 
                subsection (f), if the Secretary determines that no 
                different, comparable aspect of the elements to assure 
                safe use could satisfy the requirements of subsection 
                (f).'';
          (3) in subsection (i), by adding at the end the following:
          ``(3) Shared rems.--If the Secretary approves, in accordance 
        with paragraph (1)(C)(i)(II), a different, comparable aspect of 
        the elements to assure safe use under subsection (f) for a drug 
        that is the subject of an abbreviated new drug application 
        under section 505(j), the Secretary may require that such 
        different comparable aspect of the elements to assure safe use 
        can be used with respect to any other drug that is the subject 
        of an application under section 505(j) or 505(b) that 
        references the same listed drug.''; and
          (4) by adding at the end the following:
  ``(m) Separate REMS.--When used in this section, the terms 
`different, comparable aspect of the elements to assure safe use' or 
`different, comparable approved risk evaluation and mitigation 
strategies' means a risk evaluation and mitigation strategy for a drug 
that is the subject of an application under section 505(j) that uses 
different methods or operational means than the strategy required under 
subsection (a) for the applicable listed drug, or other application 
under section 505(j) with the same such listed drug, but achieves the 
same level of safety as such strategy.''.

SEC. 4. RULE OF CONSTRUCTION.

  (a) In General.--Nothing in this Act, the amendments made by this 
Act, or in section 505-1 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355-1), shall be construed as--
          (1) prohibiting a license holder from providing an eligible 
        product developer access to a covered product in the absence of 
        an authorization under this Act; or
          (2) in any way negating the applicability of a REMS with 
        ETASU, as otherwise required under such section 505-1, with 
        respect to such covered product.
  (b) Definitions.--In this section, the terms ``covered product'', 
``eligible product developer'', ``license holder'', and ``REMS with 
ETASU'' have the meanings given such terms in section 3(a).

                          Purpose and Summary

    H.R. 965, the ``Creating and Restoring Equal Access to 
Equivalent Samples Act of 2019'', was introduced on February 5, 
2019, by Reps. Cicilline (D-RI), Sensenbrenner (R-WI), Nadler 
(D-NY), Collins (R-GA), Welch (D-VT), and McKinley (R-WV), and 
referred to the Committee on Energy and Commerce and the 
Committee on the Judiciary. H.R. 965 clarifies the process by 
which a generic manufacturer could seek Food and Drug 
Administration (FDA) authorization to obtain sufficient 
quantities of samples for testing. The bill would also allow a 
generic manufacturer facing delays in receiving the requested 
samples to bring an action in federal court to obtain the 
samples it needs. Courts would be authorized to award monetary 
damages sufficient to deter future gaming. It would also 
clarify the FDA's discretion to allow generic manufacturers to 
operationalize equivalent safety protocols in a separate system 
instead of entering a shared safety protocol with brand 
manufacturers, provided that such separate protocol meets the 
same safety standard as the original system.

                  Background and Need for Legislation

    Drug prices in the United States see considerable 
reductions through market availability of multiple generic 
drugs following expiration of market exclusivity.\1\ FDA found 
that generic competition helps decrease prices most 
significantly when a third competing product is introduced into 
the market. Drug prices also continue to decrease with 
additional market entry--even up to the seventh competing 
product.\2\
---------------------------------------------------------------------------
    \1\AS Kesselheim, J Avorn, & A Sarpatwari, The High Cost of 
Prescription Drugs in the United States: Origins and Prospects for 
Reform (2016) (https://www.ncbi.nlm.nih.gov/pubmed/27552619).
    \2\Food and Drug Administration (FDA), ``Generic Competition and 
Drug Prices.'' (https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDER/ucm129385.htm).
---------------------------------------------------------------------------
    Access to brand drug samples is integral to the competition 
contemplated by the Hatch-Waxman Act.\3\ Some branded drug 
manufacturers use restricted distribution systems--including 
safety protocols called Risk Evaluation and Mitigation 
Strategies or REMS--to delay or impede generic competition 
through the delay or denial of the sale of samples needed to 
conduct testing necessary for purposes of FDA approval, or 
through the delay of negotiations on single, shared 
protocols.4}5
---------------------------------------------------------------------------
    \3\Michael Carrier, Sharing, Samples, and Generics: An Antitrust 
Framework (2017) (http://cornelllawreview.org/files/2017/11/
1.Carrierfinal.pdf).
    \4\Alex Brill, Unrealized Savings from the Misuse of REMS and Non-
REMS Barriers (2018) (https://accessiblemeds.org/sites/default/files/
201809/REMS_WhitePaper_September2018 %5B2%5D.pdf).
    \5\Id. 3
---------------------------------------------------------------------------
    The CREATES Act seeks to discourage the delay or denial of 
the sale of samples needed for purposes of submitting an 
application to the FDA by allowing a manufacturer facing delay 
tactics to bring an action in federal court for injunctive 
relief. Courts would be authorized to award monetary damages in 
an amount sufficient to deter gaming by brand manufacturers. 
FDA would also be given clarified discretion to allow generic 
manufacturers to operationalize equivalent safety protocols in 
a different separate system rather than enter a shared safety 
protocol with brand manufacturers.

                           Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress, the following hearing was used to develop or 
consider H.R. 965:
    The Subcommittee on Health held a legislative hearing 
entitled, ``Lowing the Cost of Prescription Drugs: Reducing 
Barriers to Market Competition'' on March 13, 2019, to consider 
H.R. 965, the ``Creating and Restoring Equal Access to 
Equivalent Samples Act of 2019'' and six other bills. The 
Subcommittee received testimony from the following witnesses:
          (1) Lou Kennedy, Chief Executive Officer and Owner, 
        Nephron Pharmaceuticals;
          (2) Anthony Barrueta, Senior Vice President for 
        Government Relations, Kaiser Permanente;
          (3) Michael Carrier, Distinguished Professor, Rutgers 
        Law School;
          (4) Kurt Karst, Director, Hyman, Phelps & McNamara, 
        P.C.;
          (5) Jeff Kushan, Partner, Sidley Austin LLP;
          (6) Marc M. Boutin, JD, Chief Executive Officer, 
        National Health Council; and
          (7) Chester ``Chip'' Davis, Jr., President and Chief 
        Executive Officer, Association for Accessible 
        Medicines.

                        Committee Consideration

    H.R. 965, the ``Creating and Restoring Equal Access to 
Equivalent Samples Act of 2019'' or the ``CREATES Act of 
2019'', was introduced on February 5, 2019, by Rep. David N. 
Cicilline (D-RI), and referred to the Committee on Energy and 
Commerce. The bill was subsequently referred to the 
Subcommittee on Health on February 6, 2019. Following 
legislative hearings, the Subcommittee met in open markup 
session, pursuant to notice, on H.R. 965 on March 26, 2019, for 
consideration of the bill. An amendment was offered by Mr. 
Welch (D-VT) was agreed to by a voice vote. An amendment by Mr. 
Gianforte (R-MT) and an amendment by Mr. Buchson (R-IN) were 
each defeated by a voice vote. Subsequently, the Subcommittee 
on Health agreed to a motion by Ms. Eshoo, Chairwoman of the 
Subcommittee, to favorably forward H.R. 965, amended, to the 
full Committee on Energy and Commerce by a voice vote.
    On April 3, 2019, the full Committee met in open markup 
session, pursuant to notice, to consider H.R. 965. During 
markup of the bill, an amendment in the nature of a substitute 
offered by Mr. Pallone (D-NJ) was adopted by a voice vote. At 
the conclusion of consideration of the bill, the full Committee 
agreed to a motion by Mr. Pallone, Chairman of the Committee, 
to order H.R. 965 favorably reported to the House, amended, by 
a record vote of 51 yeas to 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that a record vote was taken on final passage 
of H.R. 965. A motion by Mr. Pallone to order H.R. 965 
favorably reported to the House, amended, was agreed to by a 
record vote of 51 yeas to 0 nays. The following is that record 
vote taken during Committee consideration, including the names 
of those members voting for and against:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                           Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

                  Congressional Budget Office Estimate

    With respect to the requirements of clause (3)(c)(3) of 
rule XIII of the Rules of the House of Representatives and 
section 402 of the Congressional Budget Act of 1974, the 
Committee has received the following cost estimate for H.R. 965 
from the Director of the Congressional Budget Office:

                                     U.S. Congress,
                               Congressional Budget Office,
                                    Washington, DC, April 25, 2019.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 965, the CREATES 
Act of 2019.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Ellen Werble.
            Sincerely,
                                                Keith Hall,
                                                          Director.
    Enclosure.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    

    H.R. 965 would create a private right of action that would 
allow developers of generic drugs or biosimilar products to 
bring civil lawsuits against manufacturers of brand-name drugs 
if sufficient quantities of reference samples of a branded 
product are not made available for premarket testing. (To 
obtain marketing approval of their products from the Food and 
Drug Administration (FDA), developers of generic or biosimilar 
drugs currently must purchase reference samples to conduct the 
testing required to demonstrate that their drugs meet the FDA's 
approval criteria.)
    The bill also would remove a statutory requirement that 
manufacturers of generic or biosimilar versions of certain 
drugs that carry a significant risk of serious side effects use 
the same risk management system as the brand-name reference 
drug to ensure safe use of the product. Instead, it would 
provide the FDA with more discretion to allow those 
manufacturers to use comparable safety systems on a case-by-
case basis.
    CBO expects that the bill's provisions would allow generic 
drugs (including biosimilar versions of biologics) to enter the 
market earlier, on average, than they would under current law. 
Because of the earlier entry of lower-priced generic drugs, CBO 
estimates, enacting the legislation would reduce federal 
spending on prescription drugs and subsidies for health 
insurance. In total, CBO estimates that enacting H.R. 965 would 
decrease the deficit by $3.9 billion over the 2019-2029 period. 
That amount includes a $3.3 billion reduction in direct 
spending and a $0.6 billion increase in revenues.
    CBO also estimates that implementing H.R. 965 would 
decrease spending subject to appropriation by $118 million over 
the 2019-2024 period, assuming appropriation actions consistent 
with the bill. That decrease would result primarily because 
lower estimated drug prices would reduce costs for 
discretionary health programs.
    The estimated budgetary effect of H.R 965 is shown in Table 
1. The effects of the legislation fall primarily within budget 
functions 550 (health), and 570 (Medicare).

                                                    TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 965
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             By Fiscal Year, Millions of Dollars--
                                     -------------------------------------------------------------------------------------------------------------------
                                                                                                                                       2019-      2019-
                                       2019   2020    2021    2022     2023     2024     2025     2026     2027     2028     2029      2024       2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Decreases (-) in Direct Spending
 
Estimated Budget Authority..........      0      0     -47     -179     -310     -365     -424     -450     -478     -542     -503       -901     -3,299
Estimated Outlays...................      0      0     -47     -179     -310     -365     -424     -450     -478     -542     -503       -901     -3,299
On-budget...........................      0      0     -47     -178     -308     -363     -423     -448     -476     -540     -501       -897     -3,284
Off-budgeta.........................      0      0       *       -1       -2       -2       -2       -2       -2       -2       -2         -5        -15
 
                                                                  Increases in Revenues
 
Estimated Revenues..................      0      0       9       31       56       70       76       85       91       95       99        165        609
On-budget...........................      0      0       6       22       40       50       55       63       68       71       74        119        448
Off-budget..........................      0      0       2        9       16       20       21       22       23       24       25         46        161
 
                                                             Net Decrease (-) in the Deficit
                                                      From Changes in Direct Spending and Revenues
 
Effect on the Deficit...............      0      0     -55     -210     -366     -435     -500     -535     -568     -637     -602     -1,066     -3,908
On-budget...........................      0      0     -53     -200     -348     -414     -477     -511     -544     -611     -575     -1,015     -3,732
Off-budget..........................      0      0      -3       -9      -17      -21      -23      -24      -25      -26      -27        -51       -175
 
                                             Increases or Decreases (-) in Spending Subject to Appropriation
 
Estimated Authorization.............      0      1      -7      -23      -41      -47     n.e.     n.e.     n.e.     n.e.     n.e.       -118       n.e.
Estimated Outlays...................      0      1      -7      -23      -41      -47     n.e.     n.e.     n.e.     n.e.     n.e.       -118       n.e.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; n.e. = not estimated; * = between -$500,000 and zero.
aIncludes off-budget effects on the operating costs of the U.S. Postal Service.

    The CBO staff contact for this estimate is Ellen Werble. 
The estimate was reviewed by Leo Lex, Deputy Assistant Director 
for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to promote 
competition in the market for drugs and biological products by 
facilitating the timely entry of lower-cost generic and 
biosimilar versions of those drugs and biological products.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 965 is known to be duplicative of another Federal program, 
including any program that was included in a report to Congress 
pursuant to section 21 of Public Law 111-139 or the most recent 
Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

      Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 965 contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 states that the Act may be cited as the 
``Creating and Restoring Equal Access to Equivalent Samples Act 
of 2019'' or the ``CREATES Act of 2019''.

Section 2. Actions for delays of generic drugs and biosimilar 
        biological products

    Subsection (a) clarifies the meaning of key terms used in 
the legislation. Such terms include:
           ``Commercially Reasonable, Market-Based 
        Terms'' to include only the following: a non-
        discriminatory price that is at or below the most 
        recent wholesale acquisition cost for that drug product 
        and a schedule for delivery that meets the required 
        timelines outlined in the bill.
           ``Covered Product'' as any drug approved 
        under section 505 or any biological product that is 
        licensed under section 351 of the Public Health 
        Services Act (PHSA), including any combination of 
        products and when reasonably necessary to demonstrate 
        sameness, biosimilarity, or interchangeability, any 
        product, including any device, that is marketed or 
        intended for use with such drug or biological product. 
        This definition is intended to include all drug 
        products and biologics with the exception of products 
        that are on the drug shortage list under section 506E 
        of the Federal Food, Drug, and Cosmetic Act, unless the 
        product has been on the shortage list continuously for 
        more than 6 months or the Secretary determines that 
        inclusion of the drug in the covered product definition 
        is likely to contribute to alleviating or preventing a 
        shortage.
           ``Eligible Product Developer'' as a person 
        that seeks to develop an application for the approval 
        of a drug under section 505(b) or 505(j) or the 
        licensing of a biological product under section 351 of 
        the PHSA. This definition is intended to include 
        developers of generic products, 505(b)(2) drug 
        products, and biosimilars.
           ``License Holder'' refers to the holder of 
        an application or a license for a covered product 
        (including the holder's agents, wholesalers, 
        distributors, assigns, and corporate affiliates).
           ``Sufficient Quantities'' refers to an 
        amount of the covered product that the eligible product 
        developer determines allows it to conduct the necessary 
        testing to support their application and meet any 
        additional regulatory requirements.
    Subsection (b) allows an eligible product developer to 
bring a civil action against a license holder if the license 
holder has refused to provide sufficient quantities of the 
covered product to the eligible product developer on 
commercially reasonable, market-based terms.
    Paragraph (b)(2) sets out a series of elements that the 
eligible product developer must prove by a preponderance of 
evidence to prevail in their case. Evidence for such a case 
would include: as of the date the civil action is filed that 
the eligible product developer has not obtained sufficient 
quantities of the covered product on commercially reasonable, 
market-based terms; that the eligible product developer had 
made a request; and that the license holder has not delivered 
to the eligible product developer sufficient quantities of the 
covered product on commercially reasonable, market-based terms.
    Further, paragraph (b)(2) allows eligible product 
developers to request authorization to access products subject 
to REMS with elements to assure safe use (ETASU) if they meet 
certain safety conditions or otherwise satisfy the FDA that 
such protections will be provided, to receive from FDA 
authorization to obtain an individual covered product for 
development and testing purposes. The committee intends this 
subparagraph to require the FDA to make an authorization 
decision within 120 days of receiving such request. It further 
provides that the contents of such request must meet FDA 
requirements to provide safety protections comparable to those 
provided by the REMS for the covered product, including 
specific conditions related to protections for any clinical 
trial protocols.
    Paragraph (b)(3) establishes several affirmative defenses 
for the license holder, including to show that it has placed no 
restrictions on its agents, distributors, or wholesalers to 
sell covered products to generic manufacturers; that the 
product can be purchased by the generic manufacturer in 
sufficient quantities on commercially reasonable, market-based 
terms; or that the license holder made an offer via appropriate 
means to sell sufficient quantities of the covered product to 
the eligible product developer at commercially-reasonable, 
market-based terms and that the eligible product developer did 
not accept the offer within a reasonable timeframe.
    Paragraph (b)(4) specifies that a written request, offer to 
sell, or acceptive of such offer of a covered product between 
the eligible product developer and license holder shall be made 
by certified or registered mail with return receipt requests; 
personal delivery; or electronic means.
    Paragraph (b)(5) provides three remedies available to the 
court if the eligible product developer prevails. First, the 
court shall order that the license holder provide without delay 
sufficient quantities of the covered product on commercially 
reasonable, market-based terms to the eligible product 
developer. Second, the court shall also award reasonable 
attorney's fees and costs of the civil action to the eligible 
product developer. And finally, the court shall also award a 
monetary amount sufficient to deter the license holder from 
failing to provide sufficient quantities of a covered product 
on commercially reasonable, market-based terms.
    Subsection (c) provides that a license holder shall not be 
liable for any claim arising out of the failure of an eligible 
product developer to follow adequate safeguards to assure safe 
use of the covered product during development or testing 
activities described in this section, including transportation, 
handling, use, or disposal of the covered product by the 
eligible product developer.
    Subsection (d) clarifies that the provision of samples from 
a license holder to an eligible product developer is not a 
violation of REMS requirements.
    Subsection (e) clarifies the term ``antitrust laws'' and 
specifies that nothing in this section shall be construed to 
limit the operation of any provision of the antitrust laws.

Section 3. REMS approval process for subsequent filers

    Section 3 provides the FDA with the authority to waive the 
requirement that brand and generic developers participate in a 
shared safety protocol and clarifies that a generic drug 
developer would only be allowed to develop their own protocol 
if the FDA determines to their satisfaction that the generic 
protocol, while different, provides the same level of patient 
safety protections as the previously approved brand protocol.

Section 4. Rule of construction

    Section 4 clarifies that this legislation does not require 
eligible product developers to obtain an authorization before 
seeking access to samples, and that the bill does not negate 
any requirements related to REMS with ETASU.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

  (a) Submission of Proposed Strategy.--
          (1) Initial approval.--If the Secretary, in 
        consultation with the office responsible for reviewing 
        the drug and the office responsible for postapproval 
        safety with respect to the drug, determines that a risk 
        evaluation and mitigation strategy is necessary to 
        ensure that the benefits of the drug outweigh the risks 
        of the drug, and informs the person who submits such 
        application of such determination, then such person 
        shall submit to the Secretary as part of such 
        application a proposed risk evaluation and mitigation 
        strategy. In making such a determination, the Secretary 
        shall consider the following factors:
                  (A) The estimated size of the population 
                likely to use the drug involved.
                  (B) The seriousness of the disease or 
                condition that is to be treated with the drug.
                  (C) The expected benefit of the drug with 
                respect to such disease or condition.
                  (D) The expected or actual duration of 
                treatment with the drug.
                  (E) The seriousness of any known or potential 
                adverse events that may be related to the drug 
                and the background incidence of such events in 
                the population likely to use the drug.
                  (F) Whether the drug is a new molecular 
                entity.
          (2) Postapproval requirement.--
                  (A) In general.--If the Secretary has 
                approved a covered application (including an 
                application approved before the effective date 
                of this section) and did not when approving the 
                application require a risk evaluation and 
                mitigation strategy under paragraph (1), the 
                Secretary, in consultation with the offices 
                described in paragraph (1), may subsequently 
                require such a strategy for the drug involved 
                (including when acting on a supplemental 
                application seeking approval of a new 
                indication for use of the drug) if the 
                Secretary becomes aware of new safety 
                information and makes a determination that such 
                a strategy is necessary to ensure that the 
                benefits of the drug outweigh the risks of the 
                drug.
                  (B) Submission of proposed strategy.--Not 
                later than 120 days after the Secretary 
                notifies the holder of an approved covered 
                application that the Secretary has made a 
                determination under subparagraph (A) with 
                respect to the drug involved, or within such 
                other reasonable time as the Secretary requires 
                to protect the public health, the holder shall 
                submit to the Secretary a proposed risk 
                evaluation and mitigation strategy.
          (3) Abbreviated new drug applications.--The 
        applicability of this section to an application under 
        section 505(j) is subject to subsection (i).
          (4) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by 
        individuals at or above the level of individuals 
        empowered to approve a drug (such as division directors 
        within the Center for Drug Evaluation and Research).
  (b) Definitions.--For purposes of this section:
          (1) Adverse drug experience.--The term ``adverse drug 
        experience'' means any adverse event associated with 
        the use of a drug in humans, whether or not considered 
        drug related, including--
                  (A) an adverse event occurring in the course 
                of the use of the drug in professional 
                practice;
                  (B) an adverse event occurring from an 
                overdose of the drug, whether accidental or 
                intentional;
                  (C) an adverse event occurring from abuse of 
                the drug;
                  (D) an adverse event occurring from 
                withdrawal of the drug; and
                  (E) any failure of expected pharmacological 
                action of the drug, which may include reduced 
                effectiveness under the conditions of use 
                prescribed in the labeling of such drug, but 
                which may not include reduced effectiveness 
                that is in accordance with such labeling.
          (2) Covered application.--The term ``covered 
        application'' means an application referred to in 
        section 505(p)(1)(A).
          (3) New safety information.--The term ``new safety 
        information'', with respect to a drug, means 
        information derived from a clinical trial, an adverse 
        event report, a postapproval study (including a study 
        under section 505(o)(3)), or peer-reviewed biomedical 
        literature; data derived from the postmarket risk 
        identification and analysis system under section 
        505(k); or other scientific data deemed appropriate by 
        the Secretary about--
                  (A) a serious risk or an unexpected serious 
                risk associated with use of the drug that the 
                Secretary has become aware of (that may be 
                based on a new analysis of existing 
                information) since the drug was approved, since 
                the risk evaluation and mitigation strategy was 
                required, or since the last assessment of the 
                approved risk evaluation and mitigation 
                strategy for the drug; or
                  (B) the effectiveness of the approved risk 
                evaluation and mitigation strategy for the drug 
                obtained since the last assessment of such 
                strategy.
          (4) Serious adverse drug experience.--The term 
        ``serious adverse drug experience'' is an adverse drug 
        experience that--
                  (A) results in--
                          (i) death;
                          (ii) an adverse drug experience that 
                        places the patient at immediate risk of 
                        death from the adverse drug experience 
                        as it occurred (not including an 
                        adverse drug experience that might have 
                        caused death had it occurred in a more 
                        severe form);
                          (iii) inpatient hospitalization or 
                        prolongation of existing 
                        hospitalization;
                          (iv) a persistent or significant 
                        incapacity or substantial disruption of 
                        the ability to conduct normal life 
                        functions; or
                          (v) a congenital anomaly or birth 
                        defect; or
                  (B) based on appropriate medical judgment, 
                may jeopardize the patient and may require a 
                medical or surgical intervention to prevent an 
                outcome described under subparagraph (A).
          (5) Serious risk.--The term ``serious risk'' means a 
        risk of a serious adverse drug experience.
          (6) Signal of a serious risk.--The term ``signal of a 
        serious risk'' means information related to a serious 
        adverse drug experience associated with use of a drug 
        and derived from--
                  (A) a clinical trial;
                  (B) adverse event reports;
                  (C) a postapproval study, including a study 
                under section 505(o)(3);
                  (D) peer-reviewed biomedical literature;
                  (E) data derived from the postmarket risk 
                identification and analysis system under 
                section 505(k)(4); or
                  (F) other scientific data deemed appropriate 
                by the Secretary.
          (7) Responsible person.--The term ``responsible 
        person'' means the person submitting a covered 
        application or the holder of the approved such 
        application.
          (8) Unexpected serious risk.--The term ``unexpected 
        serious risk'' means a serious adverse drug experience 
        that is not listed in the labeling of a drug, or that 
        may be symptomatically and pathophysiologically related 
        to an adverse drug experience identified in the 
        labeling, but differs from such adverse drug experience 
        because of greater severity, specificity, or 
        prevalence.
  (c) Contents.--A proposed risk evaluation and mitigation 
strategy under subsection (a) shall--
          (1) include the timetable required under subsection 
        (d); and
          (2) to the extent required by the Secretary, in 
        consultation with the office responsible for reviewing 
        the drug and the office responsible for postapproval 
        safety with respect to the drug, include additional 
        elements described in subsections (e) and (f).
  (d) Minimal Strategy.--For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall 
require a timetable for submission of assessments of the 
strategy that--
          (1) includes an assessment, by the date that is 18 
        months after the strategy is initially approved;
          (2) includes an assessment by the date that is 3 
        years after the strategy is initially approved;
          (3) includes an assessment in the seventh year after 
        the strategy is so approved; and
          (4) subject to paragraphs (1), (2), and (3)--
                  (A) is at a frequency specified in the 
                strategy;
                  (B) is increased or reduced in frequency as 
                necessary as provided for in subsection 
                (g)(4)(A); and
                  (C) is eliminated after the 3-year period 
                described in paragraph (1) if the Secretary 
                determines that serious risks of the drug have 
                been adequately identified and assessed and are 
                being adequately managed.
  (e) Additional Potential Elements of Strategy.--
          (1) In general.--The Secretary, in consultation with 
        the offices described in subsection (c)(2), may under 
        such subsection require that the risk evaluation and 
        mitigation strategy for a drug include 1 or more of the 
        additional elements described in this subsection if the 
        Secretary makes the determination required with respect 
        to each element involved.
          (2) Medication guide; patient package insert.--The 
        risk evaluation and mitigation strategy for a drug may 
        require that, as applicable, the responsible person 
        develop for distribution to each patient when the drug 
        is dispensed--
                  (A) a Medication Guide, as provided for under 
                part 208 of title 21, Code of Federal 
                Regulations (or any successor regulations); and
                  (B) a patient package insert, if the 
                Secretary determines that such insert may help 
                mitigate a serious risk of the drug.
          (3) Communication plan.--The risk evaluation and 
        mitigation strategy for a drug may require that the 
        responsible person conduct a communication plan to 
        health care providers, if, with respect to such drug, 
        the Secretary determines that such plan may support 
        implementation of an element of the strategy (including 
        under this paragraph). Such plan may include--
                  (A) sending letters to health care providers;
                  (B) disseminating information about the 
                elements of the risk evaluation and mitigation 
                strategy to encourage implementation by health 
                care providers of components that apply to such 
                health care providers, or to explain certain 
                safety protocols (such as medical monitoring by 
                periodic laboratory tests)
                  (C) disseminating information to health care 
                providers through professional societies about 
                any serious risks of the drug and any protocol 
                to assure safe use; or
                  (D) disseminating information to health care 
                providers about drug formulations or 
                properties, including information about the 
                limitations or patient care implications of 
                such formulations or properties, and how such 
                formulations or properties may be related to 
                serious adverse drug events associated with use 
                of the drug.
          (4) Packaging and disposal.--The Secretary may 
        require a risk evaluation mitigation strategy for a 
        drug for which there is a serious risk of an adverse 
        drug experience described in subparagraph (B) or (C) of 
        subsection (b)(1), taking into consideration the 
        factors described in subparagraphs (C) and (D) of 
        subsection (f)(2) and in consultation with other 
        relevant Federal agencies with authorities over drug 
        disposal packaging, which may include requiring that--
                  (A) the drug be made available for dispensing 
                to certain patients in unit dose packaging, 
                packaging that provides a set duration, or 
                another packaging system that the Secretary 
                determines may mitigate such serious risk; or
                  (B) the drug be dispensed to certain patients 
                with a safe disposal packaging or safe disposal 
                system for purposes of rendering drugs 
                nonretrievable (as defined in section 1300.05 
                of title 21, Code of Federal Regulations (or 
                any successor regulation)) if the Secretary 
                determines that such safe disposal packaging or 
                system may mitigate such serious risk and is 
                sufficiently available.
  (f) Providing Safe Access for Patients to Drugs With Known 
Serious Risks That Would Otherwise Be Unavailable.--
          (1) Allowing safe access to drugs with known serious 
        risks.--The Secretary, in consultation with the offices 
        described in subsection (c)(2), may require that the 
        risk evaluation and mitigation strategy for a drug 
        include such elements as are necessary to assure safe 
        use of the drug, because of its inherent toxicity or 
        potential harmfulness, if the Secretary determines 
        that--
                  (A) the drug, which has been shown to be 
                effective, but is associated with a serious 
                adverse drug experience, can be approved only 
                if, or would be withdrawn unless, such elements 
                are required as part of such strategy to 
                mitigate a specific serious risk listed in the 
                labeling of the drug; and
                  (B) for a drug initially approved without 
                elements to assure safe use, other elements 
                under subsections (c), (d), and (e) are not 
                sufficient to mitigate such serious risk.
          (2) Assuring access and minimizing burden.--Such 
        elements to assure safe use under paragraph (1) shall--
                  (A) be commensurate with the specific serious 
                risk listed in the labeling of the drug;
                  (B) within 30 days of the date on which any 
                element under paragraph (1) is imposed, be 
                posted publicly by the Secretary with an 
                explanation of how such elements will mitigate 
                the observed safety risk;
                  (C) considering such risk, not be unduly 
                burdensome on patient access to the drug, 
                considering in particular--
                          (i) patients with serious or life-
                        threatening diseases or conditions;
                          (ii) patients who have difficulty 
                        accessing health care (such as patients 
                        in rural or medically underserved 
                        areas); and
                          (iii) patients with functional 
                        limitations; and
                  (D) to the extent practicable, so as to 
                minimize the burden on the health care delivery 
                system--
                          (i) conform with elements to assure 
                        safe use for other drugs with similar, 
                        serious risks; and
                          (ii) be designed to be compatible 
                        with established distribution, 
                        procurement, and dispensing systems for 
                        drugs.
          (3) Elements to assure safe use.--The elements to 
        assure safe use under paragraph (1) shall include 1 or 
        more goals to mitigate a specific serious risk listed 
        in the labeling of the drug and, to mitigate such risk, 
        may require that--
                  (A) health care providers who prescribe the 
                drug have particular training or experience, or 
                are specially certified (the opportunity to 
                obtain such training or certification with 
                respect to the drug shall be available to any 
                willing provider from a frontier area in a 
                widely available training or certification 
                method (including an on-line course or via 
                mail) as approved by the Secretary at 
                reasonable cost to the provider);
                  (B) pharmacies, practitioners, or health care 
                settings that dispense the drug are specially 
                certified (the opportunity to obtain such 
                certification shall be available to any willing 
                provider from a frontier area);
                  (C) the drug be dispensed to patients only in 
                certain health care settings, such as 
                hospitals;
                  (D) the drug be dispensed to patients with 
                evidence or other documentation of safe-use 
                conditions, such as laboratory test results;
                  (E) each patient using the drug be subject to 
                certain monitoring; or
                  (F) each patient using the drug be enrolled 
                in a registry.
          (4) Implementation system.--The elements to assure 
        safe use under paragraph (1) that are described in 
        subparagraphs (B), (C), and (D) of paragraph (3) may 
        include a system through which the applicant is able to 
        take reasonable steps to--
                  (A) monitor and evaluate implementation of 
                such elements by health care providers, 
                pharmacists, and other parties in the health 
                care system who are responsible for 
                implementing such elements; and
                  (B) work to improve implementation of such 
                elements by such persons.
          (5) Evaluation of elements to assure safe use.--The 
        Secretary, through the Drug Safety and Risk Management 
        Advisory Committee (or successor committee) or other 
        advisory committee of the Food and Drug Administration, 
        shall--
                  (A) seek input from patients, physicians, 
                pharmacists, and other health care providers 
                about how elements to assure safe use under 
                this subsection for 1 or more drugs may be 
                standardized so as not to be--
                          (i) unduly burdensome on patient 
                        access to the drug; and
                          (ii) to the extent practicable, 
                        minimize the burden on the health care 
                        delivery system;
                  (B) periodically evaluate, for 1 or more 
                drugs, the elements to assure safe use of such 
                drug to assess whether the elements--
                          (i) assure safe use of the drug;
                          (ii) are not unduly burdensome on 
                        patient access to the drug; and
                          (iii) to the extent practicable, 
                        minimize the burden on the health care 
                        delivery system; and
                  (C) considering such input and evaluations--
                          (i) issue or modify agency guidance 
                        about how to implement the requirements 
                        of this subsection; and
                          (ii) modify elements under this 
                        subsection for 1 or more drugs as 
                        appropriate.
          (6) Additional mechanisms to assure access.--The 
        mechanisms under section 561 to provide for expanded 
        access for patients with serious or life-threatening 
        diseases or conditions may be used to provide access 
        for patients with a serious or life-threatening disease 
        or condition, the treatment of which is not an approved 
        use for the drug, to a drug that is subject to elements 
        to assure safe use under this subsection. The Secretary 
        shall promulgate regulations for how a physician may 
        provide the drug under the mechanisms of section 561.
          (7)
          (8) Limitation.--No holder of an approved covered 
        application shall use any element to assure safe use 
        required by the Secretary under this subsection to 
        block or delay approval of an application under section 
        505(b)(2) or (j) or to prevent application of such 
        element under subsection (i)(1)(B) to a drug that is 
        the subject of an abbreviated new drug application.
  (g) Assessment and Modification of Approved Strategy.--
          (1) Voluntary assessments.--After the approval of a 
        risk evaluation and mitigation strategy under 
        subsection (a), the responsible person involved may, 
        subject to paragraph (2), submit to the Secretary an 
        assessment of the approved strategy for the drug 
        involved at any time.
          (2) Required assessments.--A responsible person shall 
        submit an assessment of the approved risk evaluation 
        and mitigation strategy for a drug--
                  (A) when submitting a supplemental 
                application for a new indication for use under 
                section 505(b) or under section 351 of the 
                Public Health Service Act, unless the drug is 
                not subject to section 503(b) and the risk 
                evaluation and mitigation strategy for the drug 
                includes only the timetable under subsection 
                (d);
                  (B) when required by the strategy, as 
                provided for in such timetable under subsection 
                (d);
                  (C) within a time period to be determined by 
                the Secretary, if the Secretary, in 
                consultation with the offices described in 
                subsection (c)(2), determines that an 
                assessment is needed to evaluate whether the 
                approved strategy should be modified to--
                          (i) ensure the benefits of the drug 
                        outweigh the risks of the drug; or
                          (ii) minimize the burden on the 
                        health care delivery system of 
                        complying with the strategy.
          (3) Requirements for assessments.--An assessment 
        under paragraph (1) or (2) of an approved risk 
        evaluation and mitigation strategy for a drug shall 
        include, with respect to each goal included in the 
        strategy, an assessment of the extent to which the 
        approved strategy, including each element of the 
        strategy, is meeting the goal or whether 1 or more such 
        goals or such elements should be modified.
          (4) Modification.--
                  (A) On initiative of responsible person.--
                After the approval of a risk evaluation and 
                mitigation strategy by the Secretary, the 
                responsible person may, at any time, submit to 
                the Secretary a proposal to modify the approved 
                strategy. Such proposal may propose the 
                addition, modification, or removal of any goal 
                or element of the approved strategy and shall 
                include an adequate rationale to support such 
                proposed addition, modification, or removal of 
                any goal or element of the strategy.
                  (B) On initiative of secretary.--After the 
                approval of a risk evaluation and mitigation 
                strategy by the Secretary, the Secretary may, 
                at any time, require a responsible person to 
                submit a proposed modification to the strategy 
                within 120 days or within such reasonable time 
                as the Secretary specifies, if the Secretary, 
                in consultation with the offices described in 
                subsection (c)(2), determines that 1 or more 
                goals or elements should be added, modified, or 
                removed from the approved strategy to--
                          (i) ensure the benefits of the drug 
                        outweigh the risks of the drug; [or]
                          (ii) minimize the burden on the 
                        health care delivery system of 
                        complying with the strategy[.]; or
                          (iii) accommodate different, 
                        comparable aspects of the elements to 
                        assure safe use for a drug that is the 
                        subject of an application under section 
                        505(j), and the applicable listed drug.
  (h) Review of Proposed Strategies; Review of Assessments and 
Modifications of Approved Strategies.--
          (1) In general.--The Secretary, in consultation with 
        the offices described in subsection (c)(2), shall 
        promptly review each proposed risk evaluation and 
        mitigation strategy for a drug submitted under 
        subsection (a) and each assessment of and proposed 
        modification to an approved risk evaluation and 
        mitigation strategy for a drug submitted under 
        subsection (g), and, if necessary, promptly initiate 
        discussions with the responsible person about such 
        proposed strategy, assessment, or modification.
          (2) Action.--
                  (A) In general.--
                          (i) Timeframe.--Unless the dispute 
                        resolution process described under 
                        paragraph (3) or (4) applies, and, 
                        except as provided in clause (ii) or 
                        clause (iii) below, the Secretary, in 
                        consultation with the offices described 
                        in subsection (c)(2), shall review and 
                        act on the proposed risk evaluation and 
                        mitigation strategy for a drug or any 
                        proposed modification to any required 
                        strategy within 180 days of receipt of 
                        the proposed strategy or modification.
                          (ii) Minor modifications.--The 
                        Secretary shall review and act on a 
                        proposed minor modification, as defined 
                        by the Secretary in guidance, within 60 
                        days of receipt of such modification.
                          (iii) REMS modification due to safety 
                        labeling changes.--Not later than 60 
                        days after the Secretary receives a 
                        proposed modification to an approved 
                        risk evaluation and mitigation strategy 
                        to conform the strategy to approved 
                        safety labeling changes, including 
                        safety labeling changes initiated by 
                        the responsible person in accordance 
                        with FDA regulatory requirements, or to 
                        a safety labeling change that the 
                        Secretary has directed the holder of 
                        the application to make pursuant to 
                        section 505(o)(4), the Secretary shall 
                        review and act on such proposed 
                        modification to the approved strategy.
                          (iv) Guidance.--The Secretary shall 
                        establish, through guidance, that 
                        responsible persons may implement 
                        certain modifications to an approved 
                        risk evaluation and mitigation strategy 
                        following notification to the 
                        Secretary.
                  (B) Inaction.--An approved risk evaluation 
                and mitigation strategy shall remain in effect 
                until the Secretary acts, if the Secretary 
                fails to act as provided under subparagraph 
                (A).
                  (C) Public availability.--Upon acting on a 
                proposed risk evaluation and mitigation 
                strategy or proposed modification to a risk 
                evaluation and mitigation strategy under 
                subparagraph (A), the Secretary shall make 
                publicly available an action letter describing 
                the actions taken by the Secretary under such 
                subparagraph (A).
          (3) Dispute resolution at initial approval.--If a 
        proposed risk evaluation and mitigation strategy is 
        submitted under subsection (a)(1) in an application for 
        initial approval of a drug and there is a dispute about 
        the strategy, the responsible person shall use the 
        major dispute resolution procedures as set forth in the 
        letters described in section 101(c) of the Food and 
        Drug Administration Amendments Act of 2007.
          (4) Dispute resolution in all other cases.--
                  (A) Request for review.--
                          (i) In general.--The responsible 
                        person may, after the sponsor is 
                        required to make a submission under 
                        subsection (a)(2) or (g), request in 
                        writing that a dispute about the 
                        strategy be reviewed by the Drug Safety 
                        Oversight Board under subsection (j), 
                        except that the determination of the 
                        Secretary to require a risk evaluation 
                        and mitigation strategy is not subject 
                        to review under this paragraph. The 
                        preceding sentence does not prohibit 
                        review under this paragraph of the 
                        particular elements of such a strategy.
                          (ii) Scheduling.--Upon receipt of a 
                        request under clause (i), the Secretary 
                        shall schedule the dispute involved for 
                        review under subparagraph (B) and, not 
                        later than 5 business days of 
                        scheduling the dispute for review, 
                        shall publish by posting on the 
                        Internet or otherwise a notice that the 
                        dispute will be reviewed by the Drug 
                        Safety Oversight Board.
                  (B) Scheduling review.--If a responsible 
                person requests review under subparagraph (A), 
                the Secretary--
                          (i) shall schedule the dispute for 
                        review at 1 of the next 2 regular 
                        meetings of the Drug Safety Oversight 
                        Board, whichever meeting date is more 
                        practicable; or
                          (ii) may convene a special meeting of 
                        the Drug Safety Oversight Board to 
                        review the matter more promptly, 
                        including to meet an action deadline on 
                        an application (including a 
                        supplemental application).
                  (C) Agreement after discussion or 
                administrative appeals.--
                          (i) Further discussion or 
                        administrative appeals.--A request for 
                        review under subparagraph (A) shall not 
                        preclude further discussions to reach 
                        agreement on the risk evaluation and 
                        mitigation strategy, and such a request 
                        shall not preclude the use of 
                        administrative appeals within the Food 
                        and Drug Administration to reach 
                        agreement on the strategy, including 
                        appeals as described in the letters 
                        described in section 101(c) of the Food 
                        and Drug Administration Amendments Act 
                        of 2007 for procedural or scientific 
                        matters involving the review of human 
                        drug applications and supplemental 
                        applications that cannot be resolved at 
                        the divisional level. At the time a 
                        review has been scheduled under 
                        subparagraph (B) and notice of such 
                        review has been posted, the responsible 
                        person shall either withdraw the 
                        request under subparagraph (A) or 
                        terminate the use of such 
                        administrative appeals.
                          (ii) Agreement terminates dispute 
                        resolution.--At any time before a 
                        decision and order is issued under 
                        subparagraph (G), the Secretary (in 
                        consultation with the offices described 
                        in subsection (c)(2)) and the 
                        responsible person may reach an 
                        agreement on the risk evaluation and 
                        mitigation strategy through further 
                        discussion or administrative appeals, 
                        terminating the dispute resolution 
                        process, and the Secretary shall issue 
                        an action letter or order, as 
                        appropriate, that describes the 
                        strategy.
                  (D) Meeting of the board.--At a meeting of 
                the Drug Safety Oversight Board described in 
                subparagraph (B), the Board shall--
                          (i) hear from both parties via 
                        written or oral presentation; and
                          (ii) review the dispute.
                  (E) Record of proceedings.--The Secretary 
                shall ensure that the proceedings of any such 
                meeting are recorded, transcribed, and made 
                public within 90 days of the meeting. The 
                Secretary shall redact the transcript to 
                protect any trade secrets and other information 
                that is exempted from disclosure under section 
                552 of title 5, United States Code, or section 
                552a of title 5, United States Code.
                  (F) Recommendation of the board.--Not later 
                than 5 days after any such meeting, the Drug 
                Safety Oversight Board shall provide a written 
                recommendation on resolving the dispute to the 
                Secretary. Not later than 5 days after the 
                Board provides such written recommendation to 
                the Secretary, the Secretary shall make the 
                recommendation available to the public.
                  (G) Action by the secretary.--
                          (i) Action letter.--With respect to a 
                        proposal or assessment referred to in 
                        paragraph (1), the Secretary shall 
                        issue an action letter that resolves 
                        the dispute not later than the later 
                        of--
                                  (I) the action deadline for 
                                the action letter on the 
                                application; or
                                  (II) 7 days after receiving 
                                the recommendation of the Drug 
                                Safety Oversight Board.
                          (ii) Order.--With respect to an 
                        assessment of an approved risk 
                        evaluation and mitigation strategy 
                        under subsection (g)(1) or under any of 
                        subparagraphs (B) through (D) of 
                        subsection (g)(2), the Secretary shall 
                        issue an order, which shall be made 
                        public, that resolves the dispute not 
                        later than 7 days after receiving the 
                        recommendation of the Drug Safety 
                        Oversight Board.
                  (H) Inaction.--An approved risk evaluation 
                and mitigation strategy shall remain in effect 
                until the Secretary acts, if the Secretary 
                fails to act as provided for under subparagraph 
                (G).
                  (I) Effect on action deadline.--With respect 
                to a proposal or assessment referred to in 
                paragraph (1), the Secretary shall be 
                considered to have met the action deadline for 
                the action letter on the application if the 
                responsible person requests the dispute 
                resolution process described in this paragraph 
                and if the Secretary has complied with the 
                timing requirements of scheduling review by the 
                Drug Safety Oversight Board, providing a 
                written recommendation, and issuing an action 
                letter under subparagraphs (B), (F), and (G), 
                respectively.
                  (J) Disqualification.--No individual who is 
                an employee of the Food and Drug Administration 
                and who reviews a drug or who participated in 
                an administrative appeal under subparagraph 
                (C)(i) with respect to such drug may serve on 
                the Drug Safety Oversight Board at a meeting 
                under subparagraph (D) to review a dispute 
                about the risk evaluation and mitigation 
                strategy for such drug.
                  (K) Additional expertise.--The Drug Safety 
                Oversight Board may add members with relevant 
                expertise from the Food and Drug 
                Administration, including the Office of 
                Pediatrics, the Office of Women's Health, or 
                the Office of Rare Diseases, or from other 
                Federal public health or health care agencies, 
                for a meeting under subparagraph (D) of the 
                Drug Safety Oversight Board.
          (5) Use of advisory committees.--The Secretary may 
        convene a meeting of 1 or more advisory committees of 
        the Food and Drug Administration to--
                  (A) review a concern about the safety of a 
                drug or class of drugs, including before an 
                assessment of the risk evaluation and 
                mitigation strategy or strategies of such drug 
                or drugs is required to be submitted under 
                subparagraph (B) or (C) of subsection (g)(2);
                  (B) review the risk evaluation and mitigation 
                strategy or strategies of a drug or group of 
                drugs; or
                  (C) review a dispute under paragraph (3) or 
                (4).
          (6) Process for addressing drug class effects.--
                  (A) In general.--When a concern about a 
                serious risk of a drug may be related to the 
                pharmacological class of the drug, the 
                Secretary, in consultation with the offices 
                described in subsection (c)(2), may defer 
                assessments of the approved risk evaluation and 
                mitigation strategies for such drugs until the 
                Secretary has convened 1 or more public 
                meetings to consider possible responses to such 
                concern.
                  (B) Notice.--If the Secretary defers an 
                assessment under subparagraph (A), the 
                Secretary shall--
                          (i) give notice of the deferral to 
                        the holder of the approved covered 
                        application not later than 5 days after 
                        the deferral;
                          (ii) publish the deferral in the 
                        Federal Register; and
                          (iii) give notice to the public of 
                        any public meetings to be convened 
                        under subparagraph (A), including a 
                        description of the deferral.
                  (C) Public meetings.--Such public meetings 
                may include--
                          (i) 1 or more meetings of the 
                        responsible person for such drugs;
                          (ii) 1 or more meetings of 1 or more 
                        advisory committees of the Food and 
                        Drug Administration, as provided for 
                        under paragraph (6); or
                          (iii) 1 or more workshops of 
                        scientific experts and other 
                        stakeholders.
                  (D) Action.--After considering the 
                discussions from any meetings under 
                subparagraph (A), the Secretary may--
                          (i) announce in the Federal Register 
                        a planned regulatory action, including 
                        a modification to each risk evaluation 
                        and mitigation strategy, for drugs in 
                        the pharmacological class;
                          (ii) seek public comment about such 
                        action; and
                          (iii) after seeking such comment, 
                        issue an order addressing such 
                        regulatory action.
          (7) International coordination.--The Secretary, in 
        consultation with the offices described in subsection 
        (c)(2), may coordinate the timetable for submission of 
        assessments under subsection (d), or a study or 
        clinical trial under section 505(o)(3), with efforts to 
        identify and assess the serious risks of such drug by 
        the marketing authorities of other countries whose drug 
        approval and risk management processes the Secretary 
        deems comparable to the drug approval and risk 
        management processes of the United States. If the 
        Secretary takes action to coordinate such timetable, 
        the Secretary shall give notice to the responsible 
        person.
          (8) Effect.--Use of the processes described in 
        paragraphs (6) and (7) shall not be the sole source of 
        delay of action on an application or a supplement to an 
        application for a drug.
  (i) Abbreviated New Drug Applications.--
          (1) In general.--A drug that is the subject of an 
        abbreviated new drug application under section 505(j) 
        is subject to only the following elements of the risk 
        evaluation and mitigation strategy required under 
        subsection (a) for the applicable listed drug:
                  (A) A Medication Guide or patient package 
                insert, if required under subsection (e) for 
                the applicable listed drug.
                  (B) A packaging or disposal requirement, if 
                required under subsection (e)(4) for the 
                applicable listed drug.
                  [(C) Elements to assure safe use, if required 
                under subsection (f) for the listed drug. A 
                drug that is the subject of an abbreviated new 
                drug application and the listed drug shall use 
                a single, shared system under subsection (f). 
                The Secretary may waive the requirement under 
                the preceding sentence for a drug that is the 
                subject of an abbreviated new drug application, 
                and permit the applicant to use a different, 
                comparable aspect of the elements to assure 
                safe use, if the Secretary determines that--
                          [(i) the burden of creating a single, 
                        shared system outweighs the benefit of 
                        a single, system, taking into 
                        consideration the impact on health care 
                        providers, patients, the applicant for 
                        the abbreviated new drug application, 
                        and the holder of the reference drug 
                        product; or
                          [(ii) an aspect of the elements to 
                        assure safe use for the applicable 
                        listed drug is claimed by a patent that 
                        has not expired or is a method or 
                        process that, as a trade secret, is 
                        entitled to protection, and the 
                        applicant for the abbreviated new drug 
                        application certifies that it has 
                        sought a license for use of an aspect 
                        of the elements to assure safe use for 
                        the applicable listed drug and that it 
                        was unable to obtain a license.
                A certification under clause (ii) shall include 
                a description of the efforts made by the 
                applicant for the abbreviated new drug 
                application to obtain a license. In a case 
                described in clause (ii), the Secretary may 
                seek to negotiate a voluntary agreement with 
                the owner of the patent, method, or process for 
                a license under which the applicant for such 
                abbreviated new drug application may use an 
                aspect of the elements to assure safe use, if 
                required under subsection (f) for the 
                applicable listed drug, that is claimed by a 
                patent that has not expired or is a method or 
                process that as a trade secret is entitled to 
                protection.]
                  (C)(i) Elements to assure safe use, if 
                required under subsection (f) for the listed 
                drug, which, subject to clause (ii), for a drug 
                that is the subject of an application under 
                section 505(j) may use--
                          (I) a single, shared system with the 
                        listed drug under subsection (f); or
                          (II) a different, comparable aspect 
                        of the elements to assure safe use 
                        under subsection (f).
                  (ii) The Secretary may require a drug that is 
                the subject of an application under section 
                505(j) and the listed drug to use a single, 
                shared system under subsection (f), if the 
                Secretary determines that no different, 
                comparable aspect of the elements to assure 
                safe use could satisfy the requirements of 
                subsection (f).
          (2) Action by secretary.--For an applicable listed 
        drug for which a drug is approved under section 505(j), 
        the Secretary--
                  (A) shall undertake any communication plan to 
                health care providers required under subsection 
                (e)(3) for the applicable listed drug;
                  (B) shall permit packaging systems and safe 
                disposal packaging or safe disposal systems 
                that are different from those required for the 
                applicable listed drug under subsection (e)(4); 
                and
                  (C) shall inform the responsible person for 
                the drug that is so approved if the risk 
                evaluation and mitigation strategy for the 
                applicable listed drug is modified.
          (3) Shared rems.--If the Secretary approves, in 
        accordance with paragraph (1)(C)(i)(II), a different, 
        comparable aspect of the elements to assure safe use 
        under subsection (f) for a drug that is the subject of 
        an abbreviated new drug application under section 
        505(j), the Secretary may require that such different 
        comparable aspect of the elements to assure safe use 
        can be used with respect to any other drug that is the 
        subject of an application under section 505(j) or 
        505(b) that references the same listed drug.
  (j) Drug Safety Oversight Board.--
          (1) In general.--There is established a Drug Safety 
        Oversight Board.
          (2) Composition; meetings.--The Drug Safety Oversight 
        Board shall--
                  (A) be composed of scientists and health care 
                practitioners appointed by the Secretary, each 
                of whom is an employee of the Federal 
                Government;
                  (B) include representatives from offices 
                throughout the Food and Drug Administration, 
                including the offices responsible for 
                postapproval safety of drugs;
                  (C) include at least 1 representative each 
                from the National Institutes of Health and the 
                Department of Health and Human Services (other 
                than the Food and Drug Administration);
                  (D) include such representatives as the 
                Secretary shall designate from other 
                appropriate agencies that wish to provide 
                representatives; and
                  (E) meet at least monthly to provide 
                oversight and advice to the Secretary on the 
                management of important drug safety issues.
  (k) Waiver in Public Health Emergencies.--The Secretary may 
waive any requirement of this section with respect to a 
qualified countermeasure (as defined in section 319F-1(a)(2) of 
the Public Health Service Act) to which a requirement under 
this section has been applied, if the Secretary determines that 
such waiver is required to mitigate the effects of, or reduce 
the severity of, the circumstances under which--
          (1) a determination described in subparagraph (A), 
        (B), or (C) of section 564(b)(1) has been made by the 
        Secretary of Homeland Security, the Secretary of 
        Defense, or the Secretary, respectively; or
          (2) the identification of a material threat described 
        in subparagraph (D) of section 564(b)(1) has been made 
        pursuant to section 319F-2 of the Public Health Service 
        Act.
  (l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product to an eligible 
product developer (as those terms are defined in section 2(a) 
of the Creating and Restoring Equal Access to Equivalent 
Samples Act of 2019) shall not be considered a violation of the 
requirements of any risk evaluation and mitigation strategy 
that may be in place under this section for such drug.
  (m) Separate REMS.--When used in this section, the terms 
``different, comparable aspect of the elements to assure safe 
use'' or ``different, comparable approved risk evaluation and 
mitigation strategies'' means a risk evaluation and mitigation 
strategy for a drug that is the subject of an application under 
section 505(j) that uses different methods or operational means 
than the strategy required under subsection (a) for the 
applicable listed drug, or other application under section 
505(j) with the same such listed drug, but achieves the same 
level of safety as such strategy.

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