I 
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 Illi-
nois, Ms. NORTON, Ms. JAYAPAL, Mrs. CHERFILUS-MCCORMICK, Mr. 
DAVIS of Illinois, Mr. GARCI´A 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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Affordable Drug Man-
ufacturing 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: 
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‘‘SEC. 310C. MANUFACTURING OF DRUGS. 
‘‘(a) ESTABLISHMENT OF OFFICE OF DRUG MANU-
FACTURING.— 
‘‘(1) IN GENERAL.—There is established within 
the Department of Health and Human Services an 
office to be known as the Office of Drug Manufac-
turing (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 pre-
scription 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 afford-
able drugs and associated devices. 
‘‘(3) PERSONNEL.— 
‘‘(A) DIRECTOR.— 
‘‘(i) IN GENERAL.—The Office shall 
be headed by a Director, who shall be ap-
pointed by the President. 
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‘‘(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 po-
sition of Director of the Office; or 
‘‘(II) may be employed by the Of-
fice during the 6-year period begin-
ning on the date on which the reg-
istered lobbyist terminates its reg-
istration 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 appli-
cable. 
‘‘(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 en-
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tity on any date on which wrongful con-
duct is the subject of a settlement, decree 
or enforcement action described in clause 
(iii)(III) occurred— 
‘‘(I) may be appointed to the po-
sition of Director of the Office; or 
‘‘(II) may be employed by the Of-
fice during the 6-year period begin-
ning on the later of— 
‘‘(aa) the date of the settle-
ment; and 
‘‘(bb) the date on which the 
enforcement 
action 
has 
con-
cluded. 
‘‘(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 Fed-
eral settlement, including a Federal 
consent decree; or 
‘‘(bb) the subject of an enforce-
ment action in a court of the United 
States or by an agency. 
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‘‘(4) DUTIES.— 
‘‘(A) IN GENERAL.—The Office shall— 
‘‘(i) prepare and submit applications 
for approval to the Food and Drug Admin-
istration, or enter into contracts for such 
submission, for the manufacture of appli-
cable drugs when authorized under this 
section, and in accordance with subpara-
graph (G); 
‘‘(ii) acquire rights to manufacture 
applicable drugs as authorized under this 
section; 
‘‘(iii) manufacture, or enter into con-
tracts with entities, with preference for 
nonprofit entities and public partners, to 
manufacture, applicable drugs as author-
ized under this section; 
‘‘(iv) determine a fair price for each 
applicable drug, in accordance with sub-
paragraph (B); 
‘‘(v) 
sell 
manufactured 
applicable 
drugs at a fair price as authorized under 
this section; and 
‘‘(vi) manufacture, or enter into con-
tracts with entities, with preference for 
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‘‘(vii) the impact of formulary design 
on patient access to the applicable drug; 
and 
‘‘(viii) the cost to acquire the applica-
ble drug at the National Average Drug Ac-
quisition 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 INGREDI-
ENTS.— 
‘‘(i) IN GENERAL.—The Office shall 
manufacture, or enter into contracts with 
entities to manufacture, an active pharma-
ceutical 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 nec-
essary for the manufacture of medical 
countermeasures or medicines deemed 
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essential from a public health perspec-
tive; 
‘‘(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 manu-
facture of applicable drugs; or 
‘‘(V) the manufacture of such in-
gredient is necessary for, or would im-
prove 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 admin-
istrative costs of the Office with respect to 
the ingredient, and the impact of such 
price on market competition for the ingre-
dient. 
‘‘(F) PURCHASE
REQUIREMENTS.—Not-
withstanding applicable laws relating to the 
procurement of prescription drugs, the Office 
shall establish minimum purchase requirements 
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for the Department of Veterans Affairs, the De-
partment of Defense, the Public Health Service, 
and the Coast Guard to purchase drugs manu-
factured by or as a result of the Office. 
‘‘(G) LIMITATION
ON
UNDUE
INFLU-
ENCE.—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 address-
ing drug shortages in the pharmaceutical mar-
ket; 
‘‘(C) improving public health; 
‘‘(D) addressing health disparities; 
‘‘(E) reducing the cost of prescription 
drugs to Federal and State health programs; or 
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‘‘(F) addressing public health emergencies 
as defined in this Act, the National Emer-
gencies Act, and the Robert T. Stafford Dis-
aster Relief and Emergency Assistance Act, in 
coordination with the Biomedical Advanced Re-
search and Development Authority, the Admin-
istration for Strategic Preparedness and Re-
sponse, the Centers for Disease Control and 
Prevention, and any other Federal agency that 
the Office determines necessary, to enable effi-
cient procurement, including contracting, for 
the Federal emergency response. 
‘‘(6) MANUFACTURING
LEVELS.—Not later 
than 1 year after the date of enactment of this sec-
tion, the Office shall manufacture, or enter into con-
tracts 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 manu-
facture, 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 Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate, and the Committee on Energy and 
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Commerce of the House of Representatives, an an-
nual report that includes— 
‘‘(A) an assessment of the major problems 
faced by patients in accessing affordable appli-
cable drugs; 
‘‘(B) a description of the status of all 
medications for which manufacturing has been 
authorized under this section, including medica-
tions 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 manufac-
tured 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 manufac-
turing has been authorized under this section 
and the use of such funds; 
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‘‘(E) an analysis of how the public manu-
facture of drugs meeting the conditions de-
scribed in paragraph (5) would impact, or has 
already impacted, competition, access to such 
drugs, the costs of such drugs, the costs of pre-
scription drugs to Federal and State health pro-
grams, 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 ap-
plicable drug that the Office determines should be manu-
factured, 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 
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into a contract with another entity to submit an ap-
plication 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 Cos-
metic 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 appli-
cable 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 
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marketing the applicable drug, the ap-
proved application for the drug. 
‘‘(ii) CONTINUED COMPLIANCE WITH 
FDA REQUIREMENTS.—The Office shall en-
sure that any application purchased under 
clause (i) is consistent with existing stand-
ards applied by the Food and Drug Ad-
ministration related to the transfer of own-
ership rights for an approved application, 
including any additional filing require-
ments 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 pur-
chasing an approved application under subpara-
graph (A)— 
‘‘(i) fails to market the applicable 
drug within 6 months of the date of such 
purchase; or 
‘‘(ii) increases the average manufac-
turer price for the applicable drug above 
the fair price (increased by the consumer 
price index for all urban consumers (as 
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published by the Bureau of Labor Statis-
tics) for that year), 
the Office shall revoke the purchaser’s approved 
application and resume production of the appli-
cable drug. The Office may waive the applica-
tion of this subparagraph in the case of a Na-
tional Emergency or in any other case deter-
mined 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 es-
tablish an advisory council to inform the Office on 
the identification of applicable drugs, market land-
scape, and supply chain considerations to ensure de-
livery of applicable drugs to consumers. The advi-
sory 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. 
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‘‘(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 Of-
fice shall begin the public manufacturing of at least 1 in-
haler, meeting the definition of applicable drug and in ac-
cordance 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 epi-
nephrine 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 ap-
plicable 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 
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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 anti-
biotics meeting the definition of applicable drug in accord-
ance 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 sec-
tion 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 sec-
tion 351 of the Public Health Service Act, or clearance 
under section 510(k) of the Federal Food, Drug, and Cos-
metic Act, is in effect, and— 
‘‘(1)(A) for which, with respect to a drug in-
cluded 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 biologi-
cal product has expired; 
‘‘(B) any period of regulatory exclusivity grant-
ed under— 
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‘‘(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 ex-
tension of such a period granted under para-
graph (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 ap-
proved abbreviated new drug application or bio-
similar (not including manufacturers of authorized 
generics under a new drug application or biosimilar), 
and that— 
‘‘(I) in the previous 5-year period, has ex-
perienced an increase in the wholesale acquisi-
tion cost by at least 1 of its manufacturers that 
is greater than the consumer price index for all 
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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 acqui-
sition cost that the Office determines to be a 
barrier to patient access; and 
‘‘(bb) is listed by the World Health Orga-
nization 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. 
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‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section.’’. 
Æ 
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