Safe Medicine Act
This bill authorizes the Food and Drug Administration to temporarily ban the sale of a drug if (1) the drug (or an active ingredient of the drug) is manufactured in a country that, because of systemic problems of supervision, may be producing contaminated drugs; and (2) the drug's labeling does not have certain warnings about potential contamination.
The bill also requires the Department of Health and Human Services to report to Congress on vulnerabilities in the U.S. medicine supply chain, including vulnerabilities related to reliance on production from other countries.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5982 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 5982
To direct the Secretary of Health and Human Services to study American
dependence on Chinese pharmaceuticals and to empower the Food and Drug
Administration to issue boxed warnings in the case of critical
contamination.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 26, 2020
Mr. Posey (for himself and Mr. Ryan) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to study American
dependence on Chinese pharmaceuticals and to empower the Food and Drug
Administration to issue boxed warnings in the case of critical
contamination.
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.
(a) 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) Domestic pharmaceutical facilities are inspected every
2 years, whereas foreign pharmaceutical facilities are
inspected only every 9 years. Further, inspections of foreign
facilities by the Food and Drug Administration have declined in
the past 2 years. In the People's Republic of China, these
inspections have fallen by more than 10 percent.
(6) 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 two 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. United States dependence on Chinese
medicine and pharmaceutical ingredients poses a national
security risk.
(b) Purposes.--The purposes of this Act are--
(1) to direct the Secretary of Health and Human Services to
study the dependence of the United States on Chinese drugs; and
(2) to authorize the Food and Drug Administration to order
a temporary boxed warning on potentially contaminated drugs.
SEC. 3. STUDY OF DEPENDENCE OF UNITED STATES ON CHINESE DRUGS.
Not later than one year after the date of the enactment of this
Act, the Secretary of Health and Human Services, in consultation with
the heads of other appropriate Federal departments and agencies, shall
submit to Congress a report on vulnerabilities to the United States
medicine supply chain. Such report shall include--
(1) an identification of any finished drugs and their
essential components including raw materials, chemical
components, and active ingredients necessary for the
manufacture of medicines whose supply is at risk of disruption
due to dependence on a single or limited number of providing
countries;
(2) an identification of the defense and geopolitical
contingencies that are sufficiently likely to arise that may
disrupt, strain, compromise, or eliminate supply chains of
medicines and their essential components and recommendations
for reasonable preparation for the occurrence of such
contingencies;
(3) an assessment of the resilience and capacity of the
current supply chain and industrial base to support the
population of the United States upon the occurrence of the
contingencies identified pursuant to paragraph (2), including
with respect to--
(A) the manufacturing capacity of the United
States;
(B) gaps in domestic manufacturing capabilities
including non-existent, extinct, threatened, and
single-point-of-failure capabilities; and
(C) supply chains with single points of failure and
limited resiliency;
(4) legislative, regulatory, and policy changes necessary
to avoid, or prepare for, contingencies identified pursuant to
paragraph (2);
(5) recommendations to diversify supply away from
predominant dependency on sources of supply in competitor
countries and politically unstable countries that may cut off
United States supply, and address critical bottlenecks and
mitigate single points of failure and limited resilience; and
(6) an assessment of the potential impact on domestic drug
prices if the People's Republic of China were to embargo the
export of drugs and pharmaceutical ingredients to the United
States.
SEC. 4. AUTHORIZING TEMPORARY BOXED WARNINGS ON POTENTIALLY
CONTAMINATED DRUGS.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, may issue a temporary order deeming
certain drugs to be misbranded within the meaning of section 502 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), if--
(1) such drugs, or the active pharmaceutical ingredients
thereof, are 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 such drugs or active
pharmaceutical ingredients; and
(2) the labeling of such drugs does not bear a boxed
warning of the potential for contamination.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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