I 
117TH CONGRESS 
1ST SESSION 
H. R. 728 
To amend the Public Health Service Act to establish an Emergency Office 
of Manufacturing for Public Health, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 2, 2021 
Ms. SCHAKOWSKY 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 
Emergency Office of Manufacturing for Public Health, 
and for other purposes. 
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 ‘‘Pandemic Emergency 
Manufacturing Act of 2021’’. 
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. 310B. MANUFACTURING OF DRUGS, BIOLOGICAL 
PRODUCTS, DEVICES, AND PERSONAL PRO-
TECTIVE EQUIPMENT. 
‘‘(a) EMERGENCY OFFICE OF MANUFACTURING FOR 
PUBLIC HEALTH.— 
‘‘(1) ESTABLISHMENT.—There is established 
within the Department of Health and Human Serv-
ices an office to be known as the Emergency Office 
of Manufacturing for Public Health (referred to in 
this section as the ‘Office’). 
‘‘(2) PURPOSE.—The purposes of the Office 
are— 
‘‘(A) to ensure an adequate supply of, and 
increase access to, prescription drugs, biological 
products, devices, and other supplies, including 
personal protective equipment, necessary to, as 
appropriate, diagnose, mitigate, prevent, or 
treat COVID–19 and to mitigate the harm the 
COVID–19 pandemic might otherwise cause for 
the strategic national stockpile under section 
319F–2, Federal, State, local, and Native 
health programs, and the commercial market; 
‘‘(B) to address shortages in the strategic 
national stockpile and commercial market of 
prescription drugs, biological products, devices, 
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and personal protective equipment used to treat 
conditions other than COVID–19; and 
‘‘(C) to provide prescription drugs, biologi-
cal products, devices, and personal protective 
equipment necessary to diagnose, mitigate, pre-
vent, and treat COVID–19 and to mitigate the 
harm the COVID–19 pandemic might otherwise 
cause, to Federal, State, local, and Native 
health programs, at no cost, and to consumers 
in the commercial market and other inter-
national entities at cost. 
‘‘(3) PERSONNEL.— 
‘‘(A) DIRECTOR.— 
‘‘(i) IN GENERAL.—The Office shall 
be headed by a Director, who shall be ap-
pointed by the President, not later than 15 
days after the date of enactment of the 
Pandemic Emergency Manufacturing Act 
of 2021, by and with the advice and con-
sent of the Senate. 
‘‘(ii) ACTING DIRECTOR.—The Assist-
ant Secretary for Preparedness and Re-
sponse, if in compliance with subparagraph 
(C), may serve as Director of the Office in 
an acting capacity until the later of Senate 
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confirmation of a Director or 3 months 
after date of enactment of the Pandemic 
Emergency Manufacturing Act of 2021. 
‘‘(iii) COMPENSATION.—The Director 
shall be compensated at the rate prescribed 
for level III of the Executive Schedule 
under section 5314 of title 5, United 
States Code. 
‘‘(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 manufacturer lob-
byist— 
‘‘(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 
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of 1995 or the agent terminates its 
status, as applicable. 
‘‘(ii) SENIOR
EXECUTIVES
OF
LAW- 
BREAKING COMPANIES.—No former senior 
executive of a covered entity— 
‘‘(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.—For pur-
poses of clause (ii), the term ‘covered enti-
ty’ means any entity that is— 
‘‘(I) a drug manufacturer; and 
‘‘(II)(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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‘‘(III) the cost to acquire or man-
ufacture applicable COVID–19 prod-
uct under this section. 
‘‘(ii) FAIR PRICE.—In determining a 
fair price for an applicable drug, biological 
product, or device under subparagraph 
(A)(iv) the Office shall consider— 
‘‘(I) the impact of price on pa-
tient access to the applicable drug, bi-
ological product, or device; 
‘‘(II) the cost of the applicable 
drug, biological product, or device to 
Federal or State health care pro-
grams; 
‘‘(III) the cost to the Federal 
Government of manufacturing the ap-
plicable drug, biological product, or 
device; 
‘‘(IV) the administrative costs of 
operating the Office; 
‘‘(V) the cost to acquire or manu-
facture the applicable drug, biological 
product, or device under this section; 
and 
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‘‘(VI) the impact of price on 
market competition for the applicable 
drug, biological product, or device. 
‘‘(iii) 
TRANSPARENCY.—All 
prices 
charged for applicable COVID–19 products 
and applicable drugs, biological products, 
or devices shall be made publicly available 
by the Office. 
‘‘(C) OBTAINING
RIGHTS
TO
MANUFAC-
TURE AND MARKET.— 
‘‘(i) IN GENERAL.—When necessary to 
fulfill the Office’s duties under this section, 
the Office shall acquire the rights to manu-
facture and market applicable COVID–19 
products and applicable drugs, biological 
products, and devices as authorized under 
this section. 
‘‘(ii) LICENSING AUTHORITY.— 
‘‘(I) 
IN
GENERAL.—Notwith-
standing any other provision of law, 
the Secretary shall issue licenses, as 
useful for fulfilling the duties under 
this Act, allowing the Office to prac-
tice or have practiced (which may in-
clude licensure of retroactive practice) 
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any invention in the United States or 
territories of the United States, in-
cluding making, using, offering to sell 
or selling, importing, or exporting 
such invention, to reference or rely 
upon clinical trial data submitted to a 
regulatory authority or the grant of 
marketing approval, and to access and 
use otherwise confidential informa-
tion, including know-how, related to 
the manufacture of an applicable 
COVID–19 
product 
or 
applicable 
drug, biological product, or device. 
‘‘(II) NON-VOLUNTARY
LICENS-
ING.—For any license that involves a 
non-voluntary authorization to use 
patented inventions, regulatory test 
data, data, know-how or other intel-
lectual property rights, the license 
shall provide for reasonable remunera-
tion to rights holders such as a rea-
sonable royalty on the sales of prod-
uct, a 1-time payment, or some com-
bination, provided that the combined 
royalty payments to all rights holders 
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shall not exceed the percentage of 
sales that is the average percent of all 
royalty payments reported to the In-
ternal Revenue Service by companies 
in the pharmaceutical and medicines 
sector, North American Industry Clas-
sification System code 325410, pro-
vided that when products are distrib-
uted for free, the royalty shall be 
based upon the cost of goods. When 
there are multiple rights holders, the 
allocation of the total royalty pay-
ments shall be determined by— 
‘‘(aa) agreement among the 
rights holders; 
‘‘(bb) allocation by arbitra-
tion among the rights holders; or 
‘‘(cc) if neither item (aa) 
nor (bb) applies, by the Office. 
‘‘(iii) 
TRANSPARENCY.—Subject 
to 
clause (iv), the Secretary shall post any 
contract agreement under subparagraph 
(A) or license issued under clause (ii) on 
the public internet website of the Depart-
ment of Health and Human Services, on 
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the date on which such agreement or li-
cense takes effect. 
‘‘(iv) PROTECTED INFORMATION.—In 
carrying out this section, the Secretary 
shall enforce applicable law concerning the 
protection of confidential commercial infor-
mation and trade secrets. 
‘‘(D) ACTIVE PHARMACEUTICAL INGREDI-
ENTS.— 
‘‘(i) IN GENERAL.—The Office shall 
manufacture, or enter into contracts with 
entities to manufacture, an active pharma-
ceutical ingredient applicable to a drug or 
biological product that is either an applica-
ble COVID–19 product or an applicable 
drug or biological product if— 
‘‘(I) the Office determines that 
such ingredient is not readily available 
from existing suppliers or the existing 
supply of such ingredient to the do-
mestic market is vulnerable to disrup-
tion; 
‘‘(II) the manufacture of such in-
gredient would improve the ability of 
other entities to enter the market for 
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the 
manufacture 
of 
applicable 
COVID–19 products or applicable 
drugs, biological products, or devices, 
or otherwise expand the manufacture 
of applicable COVID–19 products or 
applicable drugs, biological products, 
or devices; or 
‘‘(III) the manufacture of such 
ingredient is necessary for the Office 
to carry out its duties under this sec-
tion. 
‘‘(ii) 
PRICE
DETERMINATIONS.—In 
determining the price at which to sell an 
active pharmaceutical ingredient manufac-
tured in accordance with clause (i), the Of-
fice 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. 
‘‘(E) PRIORITY.—In awarding contracts 
under this paragraph, the Office shall prioritize 
entities manufacturing applicable COVID–19 
products and applicable drugs, biological prod-
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ucts, and devices using components originating 
and manufactured in the United States. 
‘‘(F) CONTRACT REQUIREMENTS.—All con-
tracts issued under this paragraph shall include 
a requirement that the contract recipients rea-
sonably price products produced under the con-
tract. 
‘‘(b) MANUFACTURING OF PRODUCTS.— 
‘‘(1) IN
GENERAL.—As soon as practicable 
after the date of enactment of this section, but no 
later than 1 month after such date of enactment, the 
Office shall begin— 
‘‘(A) manufacturing, or entering into con-
tracts with entities for the manufacture of ap-
plicable COVID–19 products and applicable 
drugs, 
biological 
products, 
and 
devices, 
prioritizing drugs, biological products, devices 
or personal protective equipment the manufac-
ture of which would provide the greatest public 
health impact; and 
‘‘(B) constructing, or entering into con-
tracts to construct, manufacturing facilities, in-
cluding the construction of advanced manufac-
turing technology, RNA vaccines, DNA vac-
cines, recombinant protein vaccines, viral vec-
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tor-based vaccines, live attenuated vaccines, in-
activated vaccines, or other therapeutics, after 
clinical data relating to such products have 
demonstrated strong positive indications of 
safety and efficacy, to ensure immediate pro-
duction at-scale upon Federal approval. 
‘‘(2) SUBMISSION OF APPLICATIONS.—For each 
applicable COVID–19 product, and for each applica-
ble drug, biological product, or device that the Office 
determines should be manufactured, as provided for 
under this section, the Secretary shall— 
‘‘(A) submit an application under sub-
section (b) or (j) of section 505, or under sec-
tion 515, of the Federal Food, Drug, and Cos-
metic Act or subsection (a) or (k) of section 
351 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 an-
other entity to submit such an application or 
notification); 
‘‘(B) request an emergency use authoriza-
tion of the product under section 564A of the 
Federal Food, Drug, and Cosmetic Act (or 
enter into a contract with another entity to sub-
mit an application for such use); or 
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‘‘(C) obtain from the holder of an applica-
tion approved under subsection (c) or (j) of sec-
tion 505 or section 515 of the Federal Food, 
Drug, and Cosmetic Act or subsection (a) or 
(k) of section 351 of the Public Health Service 
Act, or cleared under section 510(k) of the Fed-
eral Food, Drug, and Cosmetic Act, rights to 
manufacture such applicable drug. 
‘‘(3) MANUFACTURING TIMELINES.— 
‘‘(A) 
PERSONAL
PROTECTIVE
EQUIP-
MENT.—Not later than 1 month after the date 
of enactment of this section, the Secretary shall 
begin the public manufacturing of personal pro-
tective equipment, including surgical masks, 
surgical gowns, face shields, and N95 masks, 
meeting the definition of applicable COVID–19 
product and in accordance with this section. 
‘‘(B) COVID–19 DIAGNOSTIC TEST MATE-
RIALS.—Not later than 1 month after the date 
of enactment of this section, the Secretary shall 
begin the public manufacturing of materials 
necessary for the development of COVID–19 di-
agnostic tests, including chemical reagents, test 
swabs, and materials necessary to develop sero-
logical COVID–19 tests, meeting the definition 
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of applicable COVID–19 product and in accord-
ance with this section. 
‘‘(C) COVID–19 TREATMENT DRUGS.—As 
soon as practicable after the date of enactment 
of this section, the Secretary shall begin the 
public manufacturing of drugs and biological 
products in shortage, and any devices used to 
administer such drugs and biological products, 
that are used for treatment of severe COVID– 
19 cases, including albuterol, drugs used to 
intubate patients, antibiotics, and antivirals, 
meeting the definition of applicable COVID–19 
product and in accordance with this section. 
‘‘(4) PRIORITY
MANUFACTURING.—The Office 
shall prioritize the manufacturing of applicable 
COVID–19 products and applicable drugs, biological 
products, and devices that would have the greatest 
impact on— 
‘‘(A) diagnosing, mitigating, preventing, 
treating, or curing COVID–19; 
‘‘(B) limiting the harm the COVID–19 
pandemic might otherwise cause to public 
health and the economy; 
‘‘(C) addressing shortages of drugs, bio-
logical, products, and devices; 
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‘‘(D) reducing the cost of combating 
COVID–19 to Federal, State, local, and Native 
health programs; and 
‘‘(E) alleviating demographic disparities in 
COVID–19 outcomes or access to diagnosis, 
mitigation, prevention, and treatment. 
‘‘(c) PROVISION OF PRODUCTS.— 
‘‘(1) PROVISION
OF
APPLICABLE
COVID–19 
PRODUCTS.—The Secretary shall provide applicable 
COVID–19 products at no cost to Federal, State, 
local, and Native health programs, and other domes-
tic health care providers and suppliers, including do-
mestic commercial health care providers, as deter-
mined by the Secretary, and sell at cost applicable 
COVID–19 products to other commercial entities 
and international entities. Amounts received from 
the sale of such drugs shall be used for the activities 
of the Office. 
‘‘(2) PROVISION OF APPLICABLE DRUGS, BIO-
LOGICAL PRODUCTS AND DEVICES.—The Secretary 
shall sell applicable drugs, biological products, and 
devices produced under this section at a fair price to 
other entities. Amounts received from the sale of 
such drugs shall be used to replenish the national 
strategic stockpile under section 319F–2. 
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‘‘(d) OVERSIGHT OF CONTRACTS.—In the case of ap-
plicable COVID–19 products and applicable drugs, bio-
logical products, and devices manufactured via contracts, 
the Inspector General of the Department of Health and 
Human Services shall conduct a review of not fewer than 
1 of every 3 contracts entered into under this section, and 
of the entities entering into such contracts, to ensure that 
the Office is issuing contracts under fair and reasonable 
terms and conditions, including facilitating the procure-
ment by the Federal Government of applicable COVID– 
19 products and applicable drugs, biological products, and 
medical devices at fair and reasonable prices. The Inspec-
tor General shall make each such review public and, in 
cases where such a review identifies unreasonable prices, 
submit recommendations to Congress on how the Office 
should improve its contracting systems to ensure reason-
able pricing. 
‘‘(e) 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, a monthly report during the 
public health emergency declared by the Secretary under 
section 319 on January 31, 2020, with respect to COVID– 
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19, and a final report 3 months after the public health 
emergency has concluded, that includes— 
‘‘(1) an assessment of the major supply chain 
challenges facing hospitals, medical providers, the 
Federal Government, State, local, and tribal govern-
ments, and the private sector in procuring drugs, bi-
ological products, devices, and personal protective 
equipment to combat and prevent the spread of 
COVID–19; and 
‘‘(2) a description of the status of all drugs, bi-
ological products, devices, active pharmaceutical in-
gredients, and personal protective equipment for 
which manufacturing has been authorized under this 
section, including drugs, biological products, devices, 
active pharmaceutical ingredients, and personal pro-
tective equipment being manufactured, drugs, bio-
logical products, devices, active pharmaceutical in-
gredients, and personal protective equipment for 
which the Office has submitted an application for 
approval or a notification for clearance or classifica-
tion to the Food and Drug Administration but has 
not yet received approval, clearance, or classification, 
and drugs, biological products, devices, active phar-
maceutical ingredients, and personal protective 
equipment for which the Office has received ap-
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‘‘(A) IN GENERAL.—The term ‘applicable 
COVID–19 product’ means a product that is 
included on a list that the Secretary of Health 
and Human Services, in consultation with the 
Commissioner of Food and Drugs, the Assist-
ant Secretary for Preparedness and Response, 
and the Director of the Centers for Disease 
Control and Prevention, shall compile not later 
than 2 weeks after the date of enactment of 
this section and shall review and update, as 
necessary, every 2 weeks of— 
‘‘(i) qualified pandemic or epidemic 
products, as defined under section 319F– 
3, that are— 
‘‘(I)(aa) drugs, biological prod-
ucts, and devices that are manufac-
tured, 
used, 
designed, 
developed, 
modified, licensed or procured— 
‘‘(AA) to diagnose, mitigate, 
prevent, treat, or cure COVID– 
19; or 
‘‘(BB) to limit the harm the 
COVID–19 pandemic might oth-
erwise cause; 
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‘‘(bb) drugs, biological products, 
and devices that are manufactured, 
used, designed, developed, modified, li-
censed, or procured to diagnose, miti-
gate, prevent, treat, or cure a serious 
or life-threatening disease or condition 
caused by a product described in item 
(aa); or 
‘‘(cc) drugs, biological products, 
devices or technologies intended to en-
hance the use or effect of a drug, bio-
logical product, or device described in 
item (aa) or (bb); and 
‘‘(ii) personal protective equipment, 
including protective equipment for eyes, 
face, head, and extremities, protective 
clothing, respiratory devices, and protective 
shields and barriers, used to protect people 
from COVID–19 infection. 
‘‘(B) CONSULTATION.—In developing the 
list described in subparagraph (A), the Sec-
retary shall consult with the Administrator of 
the Federal Emergency Management Adminis-
tration and the Secretary of Defense to ensure 
that, in instances where the President has en-
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acted the Defense Production Act to produce 
applicable COVID–19 products, the Office does 
not replicate or overproduce products being de-
veloped under the Act. 
‘‘(3) NATIVE
HEALTH
PROGRAM.—The term 
‘Native health program’ shall include— 
‘‘(A) a program provided through the In-
dian Health Service; 
‘‘(B) any health program operated by— 
‘‘(i) an Indian tribe, or Tribal organi-
zation, as such terms are defined in section 
4 of the Indian Self-Determination and 
Education Assistance Act; 
‘‘(ii) an inter-tribal consortium, as de-
fined in section 501(a) of the Indian Self- 
Determination and Education Assistance 
Act; or 
‘‘(iii) an urban Indian organization, as 
defined in section 4 of the Indian Health 
Care Improvement Act; and 
‘‘(C) any health program provided through 
a Native Hawaiian health care system, as de-
fined in section 12 of the Native Hawaiian 
Health Care Improvement Act. 
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‘‘(4) DOMESTIC HEALTH CARE PROVIDER.—The 
term ‘domestic health care provider’ shall include the 
direct support professional, home health, and per-
sonal care attendant workforce. 
‘‘(g) 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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