Preventing Drug Shortages Act

I 116TH CONGRESS 2D SESSION H. R. 6080 To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 4, 2020 Mr. PETERS (for himself, Mr. ENGEL, Ms. ESHOO, Mr. GUTHRIE, Mr. SCHRA- DER, Mr. MCCAUL, Mr. HUDSON, and Mr. BILIRAKIS) introduced the fol- lowing bill; which was referred to the Committee on Energy and Com- merce A BILL To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes. 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 ‘‘Preventing Drug 4 Shortages Act’’. 5 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6080 IH SEC. 2. ADDITIONAL MANUFACTURER REPORTING RE- 1 QUIREMENTS IN RESPONSE TO SUPPLY DIS- 2 RUPTIONS. 3 (a) EXPANSION TO INCLUDE ACTIVE PHARMA- 4 CEUTICAL INGREDIENTS.—Subsection (a) of section 506C 5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 356c) is amended— 7 (1) in the matter preceding paragraph (1), by 8 inserting ‘‘or its active pharmaceutical ingredients’’ 9 after ‘‘a drug’’; and 10 (2) in the matter following paragraph (2)— 11 (A) by inserting ‘‘or its active pharma- 12 ceutical ingredients’’ before ‘‘that is likely’’; 13 (B) ‘‘or its active pharmaceutical ingre- 14 dient or ingredients’’ after ‘‘that drug’’; and 15 (C) by adding at the end the following: 16 ‘‘Notification under this subsection shall include 17 full disclosure of the problems resulting in the 18 supply disruption, the source of the active phar- 19 maceutical ingredient, any alternative sources 20 for the active pharmaceutical ingredient that 21 are known or contacted by manufacturer, infor- 22 mation concerning the extent of the supply dis- 23 ruption, the expected duration of the supply 24 disruption, the expected impact to distribution 25 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 6080 IH and availability in pharmacies, and such other 1 information as the Secretary may require.’’. 2 (b) MANUFACTURING REPORTING.—Section 506C of 3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 4 356c) is amended by adding at the end the following: 5 ‘‘(j) MANUFACTURER REPORTING.—Each manufac- 6 turer of a drug described in subsection (a) or of any active 7 pharmaceutical ingredient of such a drug shall report in 8 such manufacturer’s annual establishment registration 9 and product listing under subsections (b) and (j) of section 10 510 the specific facilities in which such drug or ingredient 11 is manufactured (including the volume manufactured at 12 each such facility) to help ensure uninterrupted supply of 13 the drug or ingredient. Information obtained through re- 14 porting under this section shall be maintained by the Sec- 15 retary in a confidential and internal manner and shall be 16 trade secret and/or confidential commercial or financial in- 17 formation pursuant to section 552(b)(4) of title 5, United 18 States Code.’’. 19 (c) CONSUMER NOTIFICATION.—Not later than one 20 year after the date of enactment of this Act, the Secretary 21 shall develop and submit to the Committee on Energy and 22 Commerce of the House of Representatives and the Com- 23 mittee on Health, Education, Labor, and Pensions of the 24 Senate legislative and regulatory recommendations for 25 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 6080 IH consumer notification in the case of a drug shortage, dis- 1 continuance, or interruption of the manufacture of a drug 2 described in section 506C(a) of the Federal Food, Drug, 3 and Cosmetic Act (21 U.S.C. 356c(a)), including rec- 4 ommendations for notification to patients and physicians, 5 pharmacists, and other practitioners authorized under ap- 6 plicable State law to prescribe or dispense drugs. 7 (d) EFFECTIVE DATE.—The amendments made by 8 this section shall take effect on the date that is 180 days 9 after the date of enactment of this Act. 10 SEC. 3. GAO REPORT ON INTRA-AGENCY COORDINATION. 11 (a) IN GENERAL.—Not later than 18 months after 12 the date of the enactment of this Act, the Comptroller 13 General of the United States shall submit to the Com- 14 mittee on Energy and Commerce of the House of Rep- 15 resentatives and the Committee on Health, Education, 16 Labor, and Pensions of the Senate a report examining the 17 Food and Drug Administration’s intra-agency coordina- 18 tion, communication, and decision making in assessing 19 drug shortage risks, and taking corrective action. 20 (b) CONTENT.—The report shall include— 21 (1) consideration of— 22 (A) risks associated with violations of cur- 23 rent good manufacturing practices; 24 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 6080 IH (B) corrective and preventative actions 1 with respect to such violations requested by the 2 Food and Drug Administration; 3 (C) the effects of potential manufacturing 4 slow-downs or shut-downs on potential drug 5 shortages, including the discontinuance of drug 6 manufacturing and marketing; 7 (D) efforts to prioritize review of applica- 8 tions for drugs that the Secretary has deter- 9 mined under section 506E of the Federal Food, 10 Drug, and Cosmetic Act (21 U.S.C. 356e) to be 11 in shortage; and 12 (E) efforts to prioritize inspections of fa- 13 cilities necessary for approval of applications for 14 drugs described in subparagraph (D); 15 (2) a description of how the Food and Drug 16 Administration proactively coordinates strategies to 17 mitigate the consequences of the violations, slow- 18 downs, and shut-downs described in paragraph (1) 19 across agencies; and 20 (3) an evaluation of changes in relevant Food 21 and Drug Administration practices that such agency 22 has proposed but not yet implemented. 23 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 6080 IH SEC. 4. IMPROVING CRITICAL INFRASTRUCTURE BY RE- 1 QUIRING RISK MANAGEMENT PLANS. 2 (a) RISK MANAGEMENT PLANS.—Section 506C of 3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 4 356c), as amended by section 2(b), is further amended by 5 adding at the end the following: 6 ‘‘(k) RISK MANAGEMENT PLANS.—The Secretary 7 may require a manufacturer of a drug described in sub- 8 section (a) to conduct periodic risk assessments— 9 ‘‘(1) to identify vulnerabilities in the manufac- 10 turing supply chain of such manufacturer; and 11 ‘‘(2) to develop plans to mitigate the risks asso- 12 ciated with any vulnerabilities so identified.’’. 13 (b) GUIDANCE.—Not later than 18 months after the 14 date of the enactment of this Act, the Secretary of Health 15 and Human Services, acting through the Commissioner of 16 Food and Drugs, shall finalize guidance implementing 17 subsection (l) of section 506C of the Federal Food, Drug, 18 and Cosmetic Act, as added by subsection (a). Such guid- 19 ance shall include guidance on— 20 (1) examples of what may be considered a vul- 21 nerability in the manufacturing supply chain in con- 22 ducting a risk assessment pursuant to such sub- 23 section; 24 VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 6080 IH (2) the timeframe within which a manufacturer 1 must conduct such an assessment and provide a re- 2 sponse to the Food and Drug Administration; 3 (3) expectations of the Secretary of Health and 4 Human Services for a manufacturer to mitigate in 5 a reasonable manner any risks associated with 6 vulnerabilities in the manufacturing supply chain 7 identified in such an assessment; and 8 (4) how the Secretary will coordinate with other 9 Federal agencies to communicate and resolve any 10 such vulnerabilities. 11 Æ VerDate Sep 11 2014 21:47 Mar 10, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H6080.IH H6080 kjohnson on DSK79L0C42PROD with BILLS