I 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 contamina- tion. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safe Medicine Act’’. 4 SEC. 2. FINDINGS. 5 (a) FINDINGS.—Congress finds the following: 6 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 5982 IH (1) Following the enactment of the Drug Price 1 Competition and Patent Term Restoration Act of 2 1984 (Public Law 98–417), the People’s Republic of 3 China was able to corner the market on generic 4 drugs, pharmaceutical ingredients, and related mate- 5 rials through its steady supply of readily exploitable 6 labor and threadbare safety regulations. Ninety per- 7 cent of the medications taken by individuals in the 8 United States are generic, rendering them especially 9 dependent on supplies originating in the People’s 10 Republic of China. 11 (2) The number of drugs produced outside of 12 the United States doubled between 2001 and 2008. 13 At present, 80 percent of the active pharmaceutical 14 ingredients used in drugs taken by individuals in the 15 United States come from overseas, mainly the Peo- 16 ple’s Republic of China and the Republic of India. 17 The United States no longer produces penicillin, 18 with the last fermentation plant phasing out of pro- 19 duction in 2004. 20 (3) In 2008, the counterfeiting of Heparin pre- 21 cursor chemicals by a Chinese-based pharmaceutical 22 plant led to the deaths of 81 individuals in the 23 United States, with 785 more being severely injured. 24 The counterfeit product cost one-hundredth of the 25 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 5982 IH price of the real product, indicating a clear economic 1 motive for distributing contaminated materials. 2 (4) In 2018, the Secretary of Health and 3 Human Services, acting through the Commissioner 4 of Food and Drugs, issued recalls of valsartan, 5 losartan, and irbesartan, common blood pressure 6 drugs. The Secretary of Health and Human Serv- 7 ices, acting through the Commissioner of Food and 8 Drugs, determined that versions of such drugs have 9 been contaminated, as a result of Chinese and In- 10 dian manufacturing practices and that one Chinese 11 company, Zhejaiang Huahai Pharmaceuticals had 12 ‘‘systemic problems of supervision’’, with the potent 13 carcinogens N-Nitroso-N-methyl-4-aminobutyric acid 14 (NMBA), N-Nitrosodimethylamine (NDMA), and N- 15 Nitrosodiethylamine (NDEA), for a period of 4 16 years before being detected. 17 (5) Domestic pharmaceutical facilities are in- 18 spected every 2 years, whereas foreign pharma- 19 ceutical facilities are inspected only every 9 years. 20 Further, inspections of foreign facilities by the Food 21 and Drug Administration have declined in the past 22 2 years. In the People’s Republic of China, these in- 23 spections have fallen by more than 10 percent. 24 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 5982 IH (6) In 2010, the People’s Republic of China 1 embargoed the shipment of rare earth metals to 2 Japan as political leverage in its negotiations over a 3 boating incident that took place between the two 4 countries in the East China Sea. National security 5 experts warn that if such an incident were to take 6 place between the United States and China, and 7 China were to embargo medicine and pharmaceutical 8 ingredients, the United States would be helpless. 9 United States dependence on Chinese medicine and 10 pharmaceutical ingredients poses a national security 11 risk. 12 (b) PURPOSES.—The purposes of this Act are— 13 (1) to direct the Secretary of Health and 14 Human Services to study the dependence of the 15 United States on Chinese drugs; and 16 (2) to authorize the Food and Drug Adminis- 17 tration to order a temporary boxed warning on po- 18 tentially contaminated drugs. 19 SEC. 3. STUDY OF DEPENDENCE OF UNITED STATES ON 20 CHINESE DRUGS. 21 Not later than one year after the date of the enact- 22 ment of this Act, the Secretary of Health and Human 23 Services, in consultation with the heads of other appro- 24 priate Federal departments and agencies, shall submit to 25 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 5982 IH Congress a report on vulnerabilities to the United States 1 medicine supply chain. Such report shall include— 2 (1) an identification of any finished drugs and 3 their essential components including raw materials, 4 chemical components, and active ingredients nec- 5 essary for the manufacture of medicines whose sup- 6 ply is at risk of disruption due to dependence on a 7 single or limited number of providing countries; 8 (2) an identification of the defense and geo- 9 political contingencies that are sufficiently likely to 10 arise that may disrupt, strain, compromise, or elimi- 11 nate supply chains of medicines and their essential 12 components and recommendations for reasonable 13 preparation for the occurrence of such contingencies; 14 (3) an assessment of the resilience and capacity 15 of the current supply chain and industrial base to 16 support the population of the United States upon 17 the occurrence of the contingencies identified pursu- 18 ant to paragraph (2), including with respect to— 19 (A) the manufacturing capacity of the 20 United States; 21 (B) gaps in domestic manufacturing capa- 22 bilities including non-existent, extinct, threat- 23 ened, and single-point-of-failure capabilities; 24 and 25 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 5982 IH (C) supply chains with single points of fail- 1 ure and limited resiliency; 2 (4) legislative, regulatory, and policy changes 3 necessary to avoid, or prepare for, contingencies 4 identified pursuant to paragraph (2); 5 (5) recommendations to diversify supply away 6 from predominant dependency on sources of supply 7 in competitor countries and politically unstable coun- 8 tries that may cut off United States supply, and ad- 9 dress critical bottlenecks and mitigate single points 10 of failure and limited resilience; and 11 (6) an assessment of the potential impact on 12 domestic drug prices if the People’s Republic of 13 China were to embargo the export of drugs and 14 pharmaceutical ingredients to the United States. 15 SEC. 4. AUTHORIZING TEMPORARY BOXED WARNINGS ON 16 POTENTIALLY CONTAMINATED DRUGS. 17 The Secretary of Health and Human Services, acting 18 through the Commissioner of Food and Drugs, may issue 19 a temporary order deeming certain drugs to be mis- 20 branded within the meaning of section 502 of the Federal 21 Food, Drug, and Cosmetic Act (21 U.S.C. 352), if— 22 (1) such drugs, or the active pharmaceutical in- 23 gredients thereof, are manufactured in a country 24 that the Secretary determines may be producing 25 VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 5982 IH contaminated drugs (or active pharmaceutical ingre- 1 dients) because of systemic problems of supervision 2 in the manufacture of such drugs or active pharma- 3 ceutical ingredients; and 4 (2) the labeling of such drugs does not bear a 5 boxed warning of the potential for contamination. 6 Æ VerDate Sep 11 2014 23:31 Feb 26, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H5982.IH H5982 pamtmann on DSKBC07HB2PROD with BILLS