Title: Safe Medicine Act
Policy area: Health

Summary:
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)]

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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.
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