Title: Safe Medicine Act
Policy area: Health

Summary:
Safe Medicine Act
This bill addresses issues related to the manufacture of drugs, including essential medicines.
The Department of Health and Human Services, the Department of Defense, and the Department of Veterans Affairs must jointly develop and implement a strategy to increase the domestic production of essential medicines, medical countermeasures, and critical inputs.
If the Food and Drug Administration determines that a drug or active pharmaceutical ingredient is manufactured in a country that may be producing contaminated drugs or ingredients due to systemic manufacturing-related problems, the labeling for that drug or ingredient must have a boxed warning about the potential for contamination.
For government procurement purposes, the President's authority to waive certain purchasing requirements that discriminate against foreign products may not be used to waive any preferences for goods that are essential medicines, medical countermeasures, or critical inputs.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5003 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 5003

 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

                            August 10, 2021

  Mr. Posey (for himself and Mr. Ryan) 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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