Safe Medicine Act

Bill: 116-hr-5982
Sponsor: full_name: Rep. Posey, Bill [R-FL-8]
Introduced: 2020-02-26
Policy area: Health
Subjects: Administrative law and regulatory procedures

Asia

China

Congressional oversight

Drug safety, medical device, and laboratory regulation

Government studies and investigations

Health care costs and insurance

Health information and medical records

Health technology, devices, supplies

Manufacturing

Prescription drugs

Public contracts and procurement

Trade restrictions
Latest action: action_date: 2020-02-26
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2020-02-26
action_desc: Introduced in House
text: <p><b>Safe Medicine Act</b></p> <p>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. </p> <p>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.</p>

tv_txt: I 116th CONGRESS 2d Session H. R. 5982 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.

1. Short title This Act may be cited as the Safe Medicine Act . 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. 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. 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.