[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2586 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2586
To address prescription drug shortages and improve the quality of
prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 27, 2023
Mr. Cardin (for himself, Ms. Smith, and Mr. Blumenthal) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To address prescription drug shortages and improve the quality of
prescription drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Drug Shortages Prevention and
Quality Improvement Act''.
SEC. 2. LENGTHEN EXPIRATION DATES TO MITIGATE CRITICAL DRUG SHORTAGES.
(a) In General.--The Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 506C-1 (21 U.S.C. 356c-1) the
following:
``SEC. 506C-2. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.
``(a) In General.--A manufacturer of a life-saving drug shall--
``(1) submit to the Secretary data and information as
required by subsection (b)(1);
``(2) conduct and submit the results, data, and information
of any studies required under subsection (b)(2); and
``(3) make any labeling change described in subsection (c)
by the date specified by the Secretary pursuant to such
subsection.
``(b) Notification.--
``(1) In general.--The Secretary may issue an order
requiring the manufacturer of any life-saving drug to submit,
in such manner as the Secretary may prescribe, data and
information from any stage of development of the drug that are
adequate to assess the stability of the drug to determine the
longest supported expiration date.
``(2) Unavailable or insufficient data and information.--If
the data and information required pursuant to an order issued
under paragraph (1) are not available or are insufficient, the
Secretary may require the manufacturer of the drug to--
``(A) conduct studies adequate to provide the data
and information in accordance with section 211.166 of
title 21, Code of Federal Regulations (or any successor
regulations); and
``(B) submit to the Secretary the results, data,
and information generated by such studies when
available.
``(c) Labeling.--The Secretary may issue an order requiring the
manufacturer of a life-saving drug to, by a specified date, make any
labeling change regarding the expiration date that the Secretary
determines to be appropriate based on the data and information required
to be submitted under this section in accordance with labeling
requirements under subparts F and G of part 211 of title 21, Code of
Federal Regulations (or any successor regulations) or any other data
and information available to the Secretary.
``(d) Confidentiality.--Nothing in this section shall be construed
as authorizing the Secretary to disclose any information that is a
trade secret or confidential information subject to section 552(b)(4)
of title 5, United States Code, or section 1905 of title 18, United
States Code.
``(e) Definition.--In this section, the term `life-saving drug'
means a drug described in section 506C(a).''.
(b) Civil Monetary Penalty.--Section 303(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by adding at the
end the following:
``(9)(A) If a manufacturer fails to submit data and information as
required under section 506C-2(b)(1), fails to conduct or submit the
results, data, and information generated by studies as required under
section 506C-2(b)(3), or fails to make a labeling change as required
under section 506C-2(c), such manufacturer shall be liable to the
United States for a civil penalty in an amount not to exceed $10,000
for each such violation.
``(B) If a violation described in subparagraph (A) is not corrected
within the 30-day period following notification by the Secretary of a
violation described in subparagraph (A), the manufacturer shall, in
addition to any penalty under subparagraph (A), be subject to a civil
monetary penalty of not more than $10,000 for each day of the violation
after such period until the violation is corrected.''.
SEC. 3. REPORTING ON INCREASES IN DEMAND FOR A DRUG.
(a) In General.--Section 506C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356c) is amended--
(1) in the section heading, by inserting ``or increase in
demand for'' after ``production of'';
(2) in subsection (a), in the matter following paragraph
(2), by striking ``drug, and the reasons for such
discontinuance or interruption'' and inserting ``drug, or
increase in the demand for such drug that is likely to lead to
a shortage of the drug, and the reasons for such
discontinuance, interruption, or increase in demand'';
(3) in subsection (b)--
(A) in paragraph (1), by striking ``; or'' and
inserting a semicolon;
(B) by redesignating paragraph (2) as paragraph
(3);
(C) by inserting after paragraph (1) the following:
``(2) in the case of an increase in the demand for a drug,
not later than 30 days after the manufacture has knowledge of
such increase; or''; and
(D) in paragraph (3), as so redesignated, by
striking ``paragraph (1)'' and inserting ``paragraph
(1) or (2)''; and
(4) in subsection (c), by inserting ``, or increase in
demand for,'' after ``the manufacture of''.
(b) Prohibited Act.--
(1) In general.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:
``(jjj) The failure to notify the Secretary as required under
section 506C(a).''.
(2) Enforcement.--Section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(c)) is amended--
(A) in paragraph (c), by adding before the period
at the end the following: ``; or (7) for having
violated section 301(jjj) if such person acted in good
faith and had a reasonable basis for not notifying as
required under section 506C''; and
(B) by adding at the end the following:
``(h) Notwithstanding subsection (a), any manufacturer who violates
section 301(jjj) shall be subject to a civil penalty in an amount not
to exceed $50,000 per violation.''.
SEC. 4. SUPPORTING CONTINUOUS MANUFACTURING TO PREVENT SHORTAGES FOR
SUSCEPTIBLE DRUGS.
(a) In General.--Subtitle B of title III of the 21st Century Cures
Act is amended by inserting after section 3016 (21 U.S.C. 399h) the
following:
``SEC. 3017. GRANTS FOR CONTINUOUS MANUFACTURING TO PREVENT DRUG
SHORTAGES.
``(a) In General.--The Secretary of Health and Human Services shall
solicit and, beginning not later than one year after the date of
enactment of the Drug Shortages Prevention and Quality Improvement Act,
receive, requests for grants from institutions of higher education or
nonprofit entities engaged in the manufacture of sterile injectable
drugs for the purpose of upgrading drug establishment to continuous
manufacturing or other advanced manufacturing capabilities.
``(b) Grant Criteria.--An institution of higher education or a
nonprofit entity shall be eligible for a grant under this section if
such institution or entity manufactures a drug that--
``(1) is categorized as an essential medicine under
Executive Order 13944;
``(2) is a sterile injectable drug; and
``(3) is vulnerable to shortage, including as determined
through notifications submitted to the Secretary under section
506C.
``(c) Grant Selection.--As a condition for accepting a grant under
this section, an institution of higher education and nonprofit entity
shall agree to develop and carrying out a robust plan focused on
sustainability of the continuous manufacturing or other advanced
manufacturing capabilities supported by the grant.
``(d) Authorization of Appropriations.--To carry out this section,
in additional to amounts otherwise made available for such purposes,
there is authorized to be appropriated $1,000,000,000 for the period of
fiscal years 2024 through 2029.
``(e) Definitions.--In this section:
``(1) Advanced manufacturing.--The term `advanced
manufacturing' means an approach for the manufacturing of drugs
that incorporates novel technology, or uses an established
technique or technology in a new or innovative that enhances
drug quality or improves the manufacturing process.
``(2) Continuous manufacturing.--The term `continuous
manufacturing'--
``(A) means a process where the input materials are
continuously fed into and transformed within the
process, and the processed output materials are
continuously removed from the system; and
``(B) consists of an integrated process that
consists of a series of 2 or more unit operations.
``(3) Sterile injectable drug.--The term `sterile
injectable drug' means a drug approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), a
biological product licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), or a combination product
(as described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(g)) whose primary mode of action is
that of a drug or biological product, that is intended for
injection for intravenous use of infusion and whose
manufacturing, distribution, and administration processes
require sterile conditions.''.
(b) GAO Study on Quality Management Purchasing.--The Comptroller
General of the United States shall conduct a study on including quality
management maturity as a factor in prescription drug purchasing by
Federal health care programs (as defined in section 1128B(f) of the
Social Security Act (42 U.S.C. 1320a-7b(f))), and not later than 2
years after the date of enactment of this Act, shall submit a report on
such study to Congress.
SEC. 5. AUTHORITY TO USE ALTERNATIVE PAYMENT UNDER THE MEDICARE PROGRAM
FOR DRUGS AND BIOLOGICALS TO PREVENT POTENTIAL DRUG
SHORTAGES.
(a) Payment Under Part B.--Section 1847A(e) of the Social Security
Act (42 U.S.C. 1395w-3a(e)) is amended--
(1) by striking ``Payment in Response to Public Health
Emergency.--In the case'' and inserting ``Payments.--
``(1) In response to public health emergency.--In the
case''; and
(2) by adding at the end the following new paragraph:
``(2) Preventing potential drug shortages.--
``(A) In general.--In the case of a drug or
biological described in subparagraph (B), the Secretary
may use the wholesale acquisition cost (or other
reasonable measure of a drug or biological price)
instead of the manufacturer's average sales price for
quarters beginning on or after the date on which the
Secretary determines the drug or biological is
described in such subparagraph and for subsequent
quarters until the end of the quarter in which such
drug or biological is removed from the drug shortage
list under section 506E of the Federal Food, Drug, and
Cosmetic Act, or in the case of a drug or biological
described in subparagraph (B)(ii)(II), the date on
which the Secretary determines the manufacturing
capacity or the number of manufacturers of such drug or
biological is sufficient to prevent a potential
shortage of the drug or biological.
``(B) Drug or biological described.--For purposes
of subparagraph (A), a drug or biological described in
this subparagraph is a drug or biological--
``(i) that is life-supporting, life-
sustaining, or intended for use in the
prevention or treatment of a debilitating
disease or condition (as those terms are
defined for purposes of section 506C of the
Federal Food, Drug, and Cosmetic Act and is
subject to the reporting requirements under
section 506C(b) of such Act), including any
such drug or biological that is used in
emergency medical care or during surgery; and
``(ii)(I) that is listed on the drug and
biological shortage list maintained by the Food
and Drug Administration pursuant to section
506E of the Federal Food, Drug, and Cosmetic
Act, and for which the manufacturer of such
drug or biological notifies the Secretary of a
permanent discontinuance or an interruption
that is likely to lead to a meaningful
disruption in the manufacturer's supply of that
drug or biological pursuant to section
506C(b)(1) of such Act; or
``(II) that was listed on such drug and
biological shortage list within the preceding 5
years and for which the manufacturing capacity
of manufacturers with an approved application
for such drug or biological, or the number of
manufacturers with an approved application for
such drug or biological, declines during a 6-
month period, as determined by the Secretary.
``(C) Provision of additional information.--For
each quarter in which the amount of payment for a drug
or biological described in subparagraph (B) pursuant to
subparagraph (A) exceeds the amount of payment for the
drug or biological otherwise applicable under this
section, the manufacturer of such drug or biological
shall provide to the Secretary information related to
the potential cause or causes of the shortage and the
expected length of the shortage with respect to such
drug.''.
(b) Additional Payment Under IPPS.--Section 1886(d)(5) of the
Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at
the end the following new subparagraph:
``(N) The Secretary shall establish a modifier or other mechanism
for purposes of tracking utilization of drugs on the shortage list
pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act,
and update the modifier to reflect the drugs on such list each calendar
year.''.
(c) GAO Study on Drug Shortages.--Not later than 2 years after the
date of enactment of this Act, the Comptroller General of the United
States shall--
(1) conduct a study on--
(A) drugs and biologicals for which payment is made
under the inpatient prospective payment system (IPPS)
under section 1886 of the Social Security Act (42
U.S.C. 1395ww) and the hospital outpatient prospective
payment system (OPPS) under section 1833(t) of the
Social Security Act (42 U.S.C. 1395l(t)) that have been
on the shortage list under section 506E of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356e(c)(2)) in
the last 5 years; and
(B) whether any changes to payment under such
payment systems would decrease--
(i) the number of drugs and biologicals on
such shortage list; or
(ii) the frequency with which the drugs and
biologicals appear on such shortage list; and
(2) submit to Congress recommendations for legislation and
administrative actions with respect to the matters described in
subparagraphs (A) and (B) of paragraph (1).
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