[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6607 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 6607
To amend the Public Health Service Act to establish an Office of Drug
Manufacturing.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 5, 2023
Ms. Schakowsky (for herself, Ms. Lee of California, Mr. Jackson of
Illinois, Ms. Norton, Ms. Jayapal, Mrs. Cherfilus-McCormick, Mr. Davis
of Illinois, Mr. Garcia of Illinois, and Mr. Grijalva) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to establish an Office of Drug
Manufacturing.
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 ``Affordable Drug Manufacturing Act of
2023''.
SEC. 2. PUBLIC MANUFACTURING OF PHARMACEUTICALS.
Part A of title III of the Public Health Service Act (42 U.S.C. 241
et seq.) is amended by adding at the end the following:
``SEC. 310C. MANUFACTURING OF DRUGS.
``(a) Establishment of Office of Drug Manufacturing.--
``(1) In general.--There is established within the
Department of Health and Human Services an office to be known
as the Office of Drug Manufacturing (referred to in this
section as the `Office').
``(2) Purpose.--The purpose of the Office is--
``(A) to increase competition, lower prices, and
address shortages in the market for prescription drugs,
including insulin, asthma and chronic obstructive
pulmonary disease (COPD) inhalers, naloxone,
epinephrine auto-injectors, and antibiotics;
``(B) to reduce the cost of prescription drugs to
Federal and State health programs, taxpayers, and
consumers; and
``(C) to increase patient access to affordable
drugs and associated devices.
``(3) Personnel.--
``(A) Director.--
``(i) In general.--The Office shall be
headed by a Director, who shall be appointed by
the President.
``(ii) Compensation.--The Director shall be
compensated at the rate prescribed for level
III of the Executive Schedule.
``(B) Employees.--The Director of the Office, in
consultation with the Secretary, may fix the number of,
and appoint and direct, all employees of the Office.
``(C) Banned individuals.--
``(i) Drug company lobbyists.--No former
registered drug industry lobbyist--
``(I) may be appointed to the
position of Director of the Office; or
``(II) may be employed by the
Office during the 6-year period
beginning on the date on which the
registered lobbyist terminates its
registration in accordance with section
4(d) of the Lobbying Disclosure Act of
1995 (2 U.S.C. 1603(d)) or the agent
terminates its status, as applicable.
``(ii) Senior executives of law-breaking
companies.--No former senior executive of a
covered entity (as defined in clause (iii)) who
was employed by such entity on any date on
which wrongful conduct is the subject of a
settlement, decree or enforcement action
described in clause (iii)(III) occurred--
``(I) may be appointed to the
position of Director of the Office; or
``(II) may be employed by the
Office during the 6-year period
beginning on the later of--
``(aa) the date of the
settlement; and
``(bb) the date on which
the enforcement action has
concluded.
``(iii) Covered entity.--The term `covered
entity' means any entity that is currently--
``(I) a drug manufacturer;
``(II) a wholesaler; and
``(III)(aa) operating under Federal
settlement, including a Federal consent
decree; or
``(bb) the subject of an
enforcement action in a court of the
United States or by an agency.
``(4) Duties.--
``(A) In general.--The Office shall--
``(i) prepare and submit applications for
approval to the Food and Drug Administration,
or enter into contracts for such submission,
for the manufacture of applicable drugs when
authorized under this section, and in
accordance with subparagraph (G);
``(ii) acquire rights to manufacture
applicable drugs as authorized under this
section;
``(iii) manufacture, or enter into
contracts with entities, with preference for
nonprofit entities and public partners, to
manufacture, applicable drugs as authorized
under this section;
``(iv) determine a fair price for each
applicable drug, in accordance with
subparagraph (B);
``(v) sell manufactured applicable drugs at
a fair price as authorized under this section;
and
``(vi) manufacture, or enter into contracts
with entities, with preference for nonprofit
entities and public partners, to manufacture
active pharmaceutical ingredients for use by
the Office or for sale to other entities.
``(B) Transparency.--All prices paid and charged
for applicable drugs and their inputs shall be made
publicly available by the Office.
``(C) Fair price.--In determining a fair price (the
price at which the Office sells an applicable drug to a
wholesaler or direct purchaser) for an applicable drug
under subparagraph (A)(iv) the Office shall consider--
``(i) the impact of price on patient access
to the applicable drug;
``(ii) the cost of the applicable drug to
Federal or State health care programs;
``(iii) the cost to the Federal Government
of manufacturing the applicable drug;
``(iv) the administrative costs of
operating the Office;
``(v) the cost to acquire or manufacture
applicable drugs under this section;
``(vi) the impact of price on market
competition for the applicable drug;
``(vii) the impact of formulary design on
patient access to the applicable drug; and
``(viii) the cost to acquire the applicable
drug at the National Average Drug Acquisition
Cost.
``(D) Acquiring right to manufacture and market.--
The Office may acquire the rights to manufacture and
market applicable drugs as authorized under this
section.
``(E) Active pharmaceutical ingredients.--
``(i) In general.--The Office shall
manufacture, or enter into contracts with
entities to manufacture, an active
pharmaceutical ingredient if--
``(I) the Office determines that
such ingredient is not readily
available from existing suppliers;
``(II) such ingredient is supplied
by a single manufacturing facility;
``(III) such ingredient is
necessary for the manufacture of
medical countermeasures or medicines
deemed essential from a public health
perspective;
``(IV) the manufacture of such
ingredient would improve the ability of
other entities to enter the market for
the manufacture of applicable drugs or
otherwise expand the manufacture of
applicable drugs; or
``(V) the manufacture of such
ingredient is necessary for, or would
improve the ability of, the Office to
carry out its duties under this
section.
``(ii) Price determinations.--In
determining what price at which to sell an
active pharmaceutical ingredient under clause
(i), the Office shall consider the cost to
manufacture the ingredient, the administrative
costs of the Office with respect to the
ingredient, and the impact of such price on
market competition for the ingredient.
``(F) Purchase requirements.--Notwithstanding
applicable laws relating to the procurement of
prescription drugs, the Office shall establish minimum
purchase requirements for the Department of Veterans
Affairs, the Department of Defense, the Public Health
Service, and the Coast Guard to purchase drugs
manufactured by or as a result of the Office.
``(G) Limitation on undue influence.--The Food and
Drug Administration shall consider an application
submitted by the Office under subparagraph (A)(i) in
the same manner in which the Administration considers
applications submitted by other manufacturers. Nothing
in this paragraph shall be construed to require the
Food and Drug Administration to give special deference
to any determination made, or application submitted, by
the Office.
``(5) Priority manufacturing.--The Office shall prioritize
the manufacturing of those applicable drugs that would have the
greatest impact on--
``(A) lowering drug costs to patients;
``(B) increasing competition and addressing drug
shortages in the pharmaceutical market;
``(C) improving public health;
``(D) addressing health disparities;
``(E) reducing the cost of prescription drugs to
Federal and State health programs; or
``(F) addressing public health emergencies as
defined in this Act, the National Emergencies Act, and
the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, in coordination with the Biomedical
Advanced Research and Development Authority, the
Administration for Strategic Preparedness and Response,
the Centers for Disease Control and Prevention, and any
other Federal agency that the Office determines
necessary, to enable efficient procurement, including
contracting, for the Federal emergency response.
``(6) Manufacturing levels.--Not later than 1 year after
the date of enactment of this section, the Office shall
manufacture, or enter into contracts with entities for the
manufacture of, not less than 15 applicable drugs. Not later
than 3 years after such date of enactment, the Office shall
manufacture, or enter into contracts with entities for the
manufacture of, not less than 25 applicable drugs.
``(7) Reports to congress.--The Director shall prepare and
submit to the President, the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on Energy
and Commerce of the House of Representatives, an annual report
that includes--
``(A) an assessment of the major problems faced by
patients in accessing affordable applicable drugs;
``(B) a description of the status of all
medications for which manufacturing has been authorized
under this section, including medications being
manufactured, medications for which the Office has
submitted an application to the Food and Drug
Administration but has not yet received approval, and
medications for which the Office has received approval
from the Food and Drug Administration but are not being
manufactured;
``(C) in the case of antibiotics manufactured under
this section, an assessment from the Centers for
Disease Control and Prevention and the Food and Drug
Administration on the impact of the manufacturing of
antibiotics on antimicrobial resistance;
``(D) an accounting of funds received from the sale
of all medications for which manufacturing has been
authorized under this section and the use of such
funds;
``(E) an analysis of how the public manufacture of
drugs meeting the conditions described in paragraph (5)
would impact, or has already impacted, competition,
access to such drugs, the costs of such drugs, the
costs of prescription drugs to Federal and State health
programs, and public health; and
``(F) a description of the challenges faced by the
Office in carrying out its duties under paragraph (4).
``(b) Submission of Applications.--For each applicable drug that
the Office determines should be manufactured, as provided for under
this section, the Office shall--
``(1) submit an application under section 505(b)(2),
505(j), or 515 of the Federal Food, Drug, and Cosmetic Act or
section 351(a) or 351(k) of this Act or submit a notification
under section 510(k) of the Federal Food, Drug, and Cosmetic
Act (or enter into a contract with another entity to submit
such an application);
``(2) request an emergency use authorization of the
product, as appropriate, under section 564 of the Federal Food,
Drug, and Cosmetic Act (or enter into a contract with another
entity to submit an application for such use); or
``(3) acquire from the holder of an application approved
under subsection (c) or (j) of section 505 or section 515 of
the Federal Food, Drug, and Cosmetic Act or section 351 of this
Act, or cleared under section 510(k) of the Federal Food, Drug,
and Cosmetic Act, rights to manufacture such applicable drug.
``(c) Use.--
``(1) In general.--The Office shall sell a drug produced
under this section at a fair price to other entities. Amounts
received by the Office from the sale of such drugs shall be
used for the activities of the Office.
``(2) Sale of approved application.--
``(A) Availability.--
``(i) In general.--For any applicable drug
that the Office is manufacturing, the Office
shall, beginning 3 years after the date on
which the Office first undertakes manufacturing
of such drug and annually thereafter, make
available for sale, to any person who commits
to manufacturing and marketing the applicable
drug, the approved application for the drug.
``(ii) Continued compliance with fda
requirements.--The Office shall ensure that any
application purchased under clause (i) is
consistent with existing standards applied by
the Food and Drug Administration related to the
transfer of ownership rights for an approved
application, including any additional filing
requirements that the purchaser would need to
be in compliance with due to material changes
in information provided in the approved
application.
``(B) Failure to use.--If the Office makes a
determination that a person purchasing an approved
application under subparagraph (A)--
``(i) fails to market the applicable drug
within 6 months of the date of such purchase;
or
``(ii) increases the average manufacturer
price for the applicable drug above the fair
price (increased by the consumer price index
for all urban consumers (as published by the
Bureau of Labor Statistics) for that year),
the Office shall revoke the purchaser's approved
application and resume production of the applicable
drug. The Office may waive the application of this
subparagraph in the case of a National Emergency or in
any other case determined appropriate by the Office.
``(d) Ensuring Patient Access.--
``(1) In general.--The Office shall carry out appropriate
activities to ensure the distribution and coverage of all
applicable drugs that the Office is manufacturing or has
entered into a contract to manufacture under this section.
``(2) Advisory council.--The Office shall establish an
advisory council to inform the Office on the identification of
applicable drugs, market landscape, and supply chain
considerations to ensure delivery of applicable drugs to
consumers. The advisory committee shall include representatives
from community and retail pharmacies, pharmacy benefit
managers, drug wholesalers, hospitals, health plans,
independent patient groups, clinicians, and consumer advocacy
organizations.
``(e) Insulin.--Not later than 1 year after the date of enactment
of this section, the Office shall begin the public manufacturing of at
least 1 insulin product of each dosage form (such as vial, pump, or pen
dosage forms) and of each different type of insulin (such as rapid-
acting, short-acting, intermediate-acting, long-acting, ultra-long
acting, and premixed), meeting the definition of applicable drug and in
accordance with this section.
``(f) Asthma and COPD Inhalers.--Not later than 1 year after the
date of enactment of this section, the Office shall begin the public
manufacturing of at least 1 inhaler, meeting the definition of
applicable drug and in accordance with this section.
``(g) Epinephrine Auto-Injector.--Not later than 1 year after the
date of enactment of this section, the Office shall begin the public
manufacturing of an epinephrine auto-injector, meeting the definition
of applicable drug and in accordance with this section.
``(h) Naloxone.--Not later than 1 year after the date of enactment
of this section, the Office shall begin the public manufacturing of
naloxone, including naloxone indicated for community use, meeting the
definition of applicable drug and in accordance with this section.
``(i) Antibiotics.--Not later than 1 year after the date of
enactment of this section, and in consultation with the Centers for
Disease Control and Prevention and the Food and Drug Administration to
ensure the appropriate use of manufactured antibiotics, the Office
shall begin the public manufacturing of no fewer than three discrete
antibiotics meeting the definition of applicable drug in accordance
with this section.
``(j) Applicable Drug.--In this section, the term `applicable drug'
means a drug (as defined in section 201 of the Federal Food, Drug, and
Cosmetic Act), biological product (as defined in section 351 of the
Public Health Service Act), or combination product (as described in
section 503(g) of the Federal Food, Drug, and Cosmetic Act) for which
an approved application under section 505 or 515 of the Federal Food,
Drug, and Cosmetic Act or section 351 of the Public Health Service Act,
or clearance under section 510(k) of the Federal Food, Drug, and
Cosmetic Act, is in effect, and--
``(1)(A) for which, with respect to a drug included in the
list described in section 505(j)(7) of the Federal Food, Drug,
and Cosmetic Act, each patent included with respect to such
drug in such list has expired, or each patent that claims a
biological product has expired;
``(B) any period of regulatory exclusivity granted under--
``(i) clause (ii), (iii), or (iv) of section
505(c)(3)(E) of the Federal Food, Drug, and Cosmetic
Act, section 505(j)(5)(B)(iv) of such Act, clause (ii),
(iii), or (iv) of section 505(j)(5)(F) of such Act,
section 527 of such Act, and any extension of such a
period granted under section 505A or 505E of such Act,
has expired; or
``(ii) paragraph (6) or (7) of section 351(k) of
the Public Health Service Act, and any extension of
such a period granted under paragraph (2) or (3) of
section 351(m) of such Act, has expired; and
``(C)(i) that is not being marketed in the United States;
or
``(ii) that is being marketed in the United States by 3 or
fewer manufacturers with an approved abbreviated new drug
application or biosimilar (not including manufacturers of
authorized generics under a new drug application or
biosimilar), and that--
``(I) in the previous 5-year period, has
experienced an increase in the wholesale acquisition
cost by at least 1 of its manufacturers that is greater
than the consumer price index for all urban consumers
(as published by the Bureau of Labor Statistics) for 1
of the years in that the same period;
``(II) is included in the drug shortage list under
section 506E of the Federal Food, Drug, and Cosmetic
Act; or
``(III)(aa) has an average wholesale acquisition
cost that the Office determines to be a barrier to
patient access; and
``(bb) is listed by the World Health Organization
as an essential medicine; or
``(2) for which there is in effect a license, or patent use
is authorized, under--
``(A) section 1498 of title 28, United States Code;
``(B) section 202 of title 35, United States Code;
``(C) section 203 of title 35, United States Code
(march-in rights);
``(D) section 209 of title 35, United States Code;
or
``(E) any other licensing authority of the Federal
Government.
``(k) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section.''.
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