[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5575 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5575
To direct the Secretaries of Health and Human Services, Defense, and
Veterans Affairs to end American over-dependence on Chinese
pharmaceuticals by encouraging the growth of a robust domestic medicine
supply chain for generic drugs, to empower the Food and Drug
Administration to issue boxed warnings in the case of critical
contamination, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 19, 2023
Mr. Posey introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Armed Services, Veterans' Affairs, and Ways and Means, for a period to
be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To direct the Secretaries of Health and Human Services, Defense, and
Veterans Affairs to end American over-dependence on Chinese
pharmaceuticals by encouraging the growth of a robust domestic medicine
supply chain for generic drugs, to empower the Food and Drug
Administration to issue boxed warnings in the case of critical
contamination, 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 ``Safe Medicine Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Following the enactment of the Drug Price Competition
and Patent Term Restoration Act of 1984 (Public Law 98-417),
the People's Republic of China was able to corner the market on
generic drugs, pharmaceutical ingredients, and related
materials through its steady supply of readily exploitable
labor and threadbare safety regulations. Ninety percent of the
medications taken by individuals in the United States are
generic, rendering them especially dependent on supplies
originating in the People's Republic of China.
(2) The number of drugs produced outside of the United
States doubled between 2001 and 2008. At present, 80 percent of
the active pharmaceutical ingredients used in drugs taken by
individuals in the United States come from overseas, mainly the
People's Republic of China and the Republic of India. The
United States no longer produces penicillin, with the last
fermentation plant phasing out of production in 2004.
(3) In 2008, the counterfeiting of Heparin precursor
chemicals by a Chinese-based pharmaceutical plant led to the
deaths of 81 individuals in the United States, with 785 more
being severely injured. The counterfeit product cost one-
hundredth of the price of the real product, indicating a clear
economic motive for distributing contaminated materials.
(4) In 2018, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, issued
recalls of Valsartan, Losartan, and Irbesartan, common blood
pressure drugs. The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, determined
that versions of such drugs have been contaminated as a result
of Chinese and Indian manufacturing practices and that one
Chinese company, Zhejaiang Huahai Pharmaceuticals, had
``systemic problems of supervision'', with the potent
carcinogens N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), N-
Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA),
for a period of 4 years before being detected.
(5) During an October 30, 2020, hearing before the Health
Subcommittee of the Energy and Commerce Committee of the House
of Representatives, it was discovered that the Food and Drug
Administration (FDA) has data on active pharmaceutical
ingredient facilities and locations because they regulate and
inspect them. But the FDA does not know how much volume is
produced at these facilities. A single plant could make 90
percent of global supply or 10 percent, but the FDA does not
know.
(6) The FDA cannot determine the United States dependence
because it does not thoroughly regulate or inspect the
facilities where the key chemicals and raw materials to make
active pharmaceutical ingredients are made.
(7) Domestic pharmaceutical facilities undergo far more
rigorous inspections than manufacturing facilities in the
People's Republic of China. Since early 2020, the FDA recalled
its inspectors from China and elsewhere to protect them from
the Coronavirus. As a result, FDA inspections have plummeted to
near zero for the past year.
(8) In 2010, the People's Republic of China embargoed the
shipment of rare earth metals to Japan as political leverage in
its negotiations over a boating incident that took place
between the 2 countries in the East China Sea. National
security experts warn that if such an incident were to take
place between the United States and China, and China were to
embargo medicine and pharmaceutical ingredients, the United
States would be helpless. Sun Yu and Demetri Sevastopulo,
``China Targets Rare Earth Export Curbs To Hobble US Defense
Industry.'' Ars Technica, February 16, 2021, arstechnica.com/
tech-policy/2021/02/china-targets-rare-earth-export-curbs-to-
hobble-us-defense-industry/. United States dependence on
Chinese medicine and pharmaceutical ingredients poses a
national security risk.
(9) The United States is dependent on other nations,
particularly China, for our generic medicine and key
ingredients that are used to make these drugs. Inspections at
Chinese facilities are inadequate compared to inspections at
facilities located in the United States.
(10) The United States cannot rely on questionable
inspections at facilities located in China.
(11) To protect Americans, we must encourage the
development of essential generic drug manufacturing here in the
United States and countries allied with the United States in a
current defense effort for the 227 essential medicines and
medical countermeasures identified by the FDA in accordance
with Executive Order 13944, issued on August 6, 2020.
SEC. 3. DOMESTIC MANUFACTURING TO END OVER-DEPENDENCE OF THE UNITED
STATES ON CHINESE DRUGS.
(a) In General.--The Secretaries of Health and Human Services,
Defense, and Veterans Affairs, acting jointly and in consultation with
the Commissioner of Food and Drugs, shall--
(1) not later than 180 days after the date of enactment of
this Act, develop a procurement strategy, including for long-
term contracts, to strengthen and mobilize the Public Health
Industrial Base to increase the manufacture in the United
States of essential medicines, medical countermeasures, and
critical inputs, including the 227 essential medicines, medical
countermeasures, and critical inputs published on October 30,
2020, by the Food and Drug Administration in accordance with
Executive Order 13944; and
(2) beginning as soon as feasible after the development of
such strategy, and not later than 5 years after the development
of such strategy, implement such strategy.
(b) Contents.--The strategy under subsection (a) shall--
(1) be consistent with all applicable Federal law;
(2) identify essential components, including key starting
materials, active ingredients, and critical inputs, necessary
for manufacturing the essential medicines and medical
countermeasures published on October 30, 2020, by the Food and
Drug Administration in accordance with Executive Order 13944;
and
(3) address the capacity of the supply chain and industrial
base to strengthen and mobilize the Public Health Industrial
Base to increase the manufacture in the United States of
essential medicines, medical countermeasures, and critical
inputs.
(c) Definitions.--In this section:
(1) The term ``critical inputs'' means active
pharmaceutical ingredients, active pharmaceutical ingredient
starting material, and other ingredients of drugs and
components of medical devices that the Commissioner of Food and
Drugs determines to be critical in assessing the safety and
effectiveness of essential medicines and medical
countermeasures.
(2) The term ``essential medicine'' means medicine--
(A) that is needed to protect the American public
at all times, including from outbreaks of emerging
infectious diseases, such as COVID-19, as well as
chemical, biological, radiological, and nuclear
threats; and
(B) of which sufficient and reliable, long-term
domestic production of these products, mostly generic
drugs, their active pharmaceutical ingredients, and key
starting materials, is needed to minimize potential
shortages by reducing the Nation's dependence on
foreign manufacturers of these products.
(3) The term ``medical countermeasure'' means--
(A) a qualified countermeasure (as defined in
section 319F-1 of the Public Health Service Act (42
U.S.C. 247d-6a));
(B) a qualified pandemic or epidemic product (as
defined in section 319F-3 of such Act (42 U.S.C. 247d-
6d));
(C) a security countermeasure (as defined in
section 319F-2 of such Act (42 U.S.C. 247d-6b)); or
(D) personal protective equipment (such as gloves,
respirators (face masks), and ventilators).
(4) The term ``Public Health Industrial Base'' means the
facilities and associated workforces within the United States,
including research and development facilities, that help
produce essential medicines, medical countermeasures, and
critical inputs for the health care and public health sector.
SEC. 4. REQUIRING BOXED WARNINGS ON POTENTIALLY CONTAMINATED DRUGS.
(a) In General.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall--
(1) issue an order deeming a drug or active pharmaceutical
ingredient (or a category thereof) to be misbranded within the
meaning of section 502 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 352) if such drug or active pharmaceutical
ingredient (or category thereof)--
(A) is manufactured in a country that the Secretary
determines may be producing contaminated drugs or
active pharmaceutical ingredients because of systemic
problems of supervision in the manufacture of drugs or
active pharmaceutical ingredients; and
(B) the labeling of such drug or active
pharmaceutical ingredient (or category thereof) does
not bear a boxed warning of the potential for
contamination;
(2) make each such order effective for a period of not more
than 180 days; and
(3) renew each such order each time the preceding order
ends and the criteria listed in paragraph (1) continue to
apply.
(b) Waivers.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs--
(1) may waive the requirement to issue or renew an order
under subsection (a) so long as the labeling of the drug or
active pharmaceutical ingredient (or category thereof) bears a
boxed warning of the potential for contamination;
(2) shall make any such waiver effective for a period not
to exceed 180 days; and
(3) may renew any such waiver one or more times.
SEC. 5. LIMITATION ON WAIVER AUTHORITY UNDER THE TRADE AGREEMENTS ACT
OF 1979.
Section 301 of the Trade Agreements Act of 1979 (19 U.S.C. 2511) is
amended by adding at the end the following:
``(g) Limitation on Waiver Authority Relating to Essential
Medicines, Medical Countermeasures, and Critical Inputs.--
``(1) In general.--The authority of the President under
subsection (a) to waive the application of any law, regulation,
procedure, or practice regarding Government procurement does
not authorize the waiver of any preferences for goods that are
essential medicines, medical countermeasures, or critical
inputs.
``(2) Definitions.--In this subsection, the terms
`essential medicines', `medical countermeasures', and `critical
inputs'--
``(A) have the meanings given such terms in section
3(c) of the Safe Medicine Act; and
``(B) include the 227 essential medicines, medical
countermeasures, and critical inputs published on
October 30, 2020, by the Food and Drug Administration
in accordance with Executive Order 13944.''.
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