Mitigating Emergency Drug Shortages Act

II 116TH CONGRESS 1ST SESSION S. 2723 To amend the Federal Food, Drug, and Cosmetic Act to reduce drug shortages, and for other purposes. IN THE SENATE OF THE UNITED STATES OCTOBER 29, 2019 Ms. COLLINS (for herself and Ms. SMITH) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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 ‘‘Mitigating Emergency 4 Drug Shortages Act’’. 5 SEC. 2. PRIORITIZE REVIEWS OF DRUG APPLICATIONS; IN- 6 CENTIVES. 7 (a) PRIORITIZED REVIEWS AND INSPECTIONS.—Sec- 8 tion 506C(g) of the Federal Food, Drug, and Cosmetic 9 Act (21 U.S.C. 356c(g)) is amended— 10 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 2 •S 2723 IS (1) in the matter preceding paragraph (1), by 1 striking ‘‘the Secretary may’’ and inserting ‘‘the 2 Secretary shall’’; 3 (2) in paragraph (1), by inserting ‘‘prioritize 4 and’’ before ‘‘expedite the review’’; and 5 (3) in paragraph (2), by inserting ‘‘prioritize 6 and’’ before ‘‘expedite an inspection’’. 7 (b) REPORT.—Not later than one year after the date 8 of enactment of this Act, the Secretary of Health and 9 Human Services shall develop and submit to the Com- 10 mittee on Health, Education, Labor, and Pensions of the 11 Senate and the Committee on Energy and Commerce of 12 the House of Representatives a report containing legisla- 13 tive and regulatory recommendations— 14 (1) to create market-based incentives or other 15 appropriate mechanisms, sufficient to encourage— 16 (A) the manufacture of drugs in shortage 17 or at risk of shortage; 18 (B) the domestic manufacture of finished 19 dosage forms of such drugs; and 20 (C) the domestic manufacture of active 21 pharmaceutical ingredients for such drugs; and 22 (2) to expand the Emerging Technology Pro- 23 gram of the Food and Drug Administration to cre- 24 ate or upgrade existing technologies to address drug 25 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 3 •S 2723 IS shortage challenges and promote modern, reliable 1 manufacturing strategies. 2 SEC. 3. ADDITIONAL MANUFACTURER REPORTING RE- 3 QUIREMENTS IN RESPONSE TO DRUG SHORT- 4 AGES. 5 (a) EXPANSION TO INCLUDE ACTIVE PHARMA- 6 CEUTICAL INGREDIENTS.—Subsection (a) of section 506C 7 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 8 356c) is amended— 9 (1) in the matter preceding paragraph (1), by 10 inserting ‘‘or its active pharmaceutical ingredients’’ 11 after ‘‘a drug’’; and 12 (2) in the flush text at the end— 13 (A) by inserting ‘‘or its active pharma- 14 ceutical ingredients’’ before ‘‘that is likely’’; 15 (B) ‘‘or its active pharmaceutical ingredi- 16 ents’’ after ‘‘that drug’’; and 17 (C) by adding at the end the following: 18 ‘‘Notification under this subsection shall include 19 full disclosure of the problems resulting in the 20 shortage, the source of the active pharma- 21 ceutical ingredient, associated medical devices 22 used for preparation or administration included 23 in the finished dosage form, any alternative 24 sources for the active pharmaceutical ingredient 25 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 4 •S 2723 IS that are known or contacted by manufacturer, 1 information concerning the extent of the short- 2 age, the expected duration of the shortage, the 3 expected impact to distribution and availability 4 in pharmacies, and such other information as 5 the Secretary may require.’’. 6 (b) MANUFACTURING REPORTING.—Section 506C of 7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 8 356c) is amended by adding at the end the following: 9 ‘‘(j) MANUFACTURER REPORTING.—Each manufac- 10 turer of a drug described in subsection (a) or of any active 11 pharmaceutical ingredient or associated medical devices 12 used for preparation or administration included in the fin- 13 ished dosage form of such a drug, shall report in such 14 manufacturer’s annual establishment registration and 15 product listing under subsections (b) and (j) of section 16 510 the specific facilities in which such drug or ingredient 17 is manufactured and contingency and redundancy plans 18 to help ensure uninterrupted supply of the drug or ingre- 19 dient. Additional manufacturer reporting requirements 20 under this section shall be maintained by the Secretary 21 in a confidential and internal manner for use by the agen- 22 cy to help ensure continued supply of such drugs.’’. 23 (c) CONSUMER NOTIFICATION.—Not later than one 24 year after the date of enactment of this Act, the Secretary 25 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 5 •S 2723 IS shall develop and submit to the Committee on Health, 1 Education, Labor, and Pensions of the Senate and the 2 Committee on Energy and Commerce of the House of 3 Representatives legislative and regulatory recommenda- 4 tions for consumer notification in the case of a drug short- 5 age, discontinuance, or interruption of the manufacture of 6 a drug described in section 506C(a) of the Federal Food, 7 Drug, and Cosmetic Act (21 U.S.C. 356c(a)), including 8 recommendations for notification to patients and physi- 9 cians, pharmacists, and other practitioners authorized 10 under applicable State law to prescribe or dispense drugs. 11 (d) REPORTING AFTER FACTORY INSPECTIONS.— 12 Section 704(b) of the Federal Food, Drug, and Cosmetic 13 Act (21 U.S.C. 374(b)) is amended— 14 (1) by redesignating paragraphs (1) and (2) 15 and subparagraphs (A) and (B); 16 (2) by striking ‘‘(b) Upon completion’’ and in- 17 serting ‘‘(b)(1) Upon completion’’; and 18 (3) by adding at the end the following: 19 ‘‘(2) In carrying out this subsection with respect to 20 any establishment manufacturing a drug approved under 21 subsection (c) or (j) of section 505 that is described in 22 506C(a) or 505(j)(11)(A), a copy of the report shall be 23 sent promptly to the appropriate offices of the Food and 24 Drug Administration with expertise regarding drug short- 25 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 6 •S 2723 IS ages. Such offices shall ensure timely and effective coordi- 1 nation regarding the reviews of such report and overseeing 2 the alignment of any feedback regarding such report, or 3 corrective or preventative actions, after consideration of 4 the systematic benefits and risks to public health, patient 5 safety, the drug supply and drug supply chain, and timely 6 patient access to such drugs.’’. 7 (e) EFFECTIVE DATE.—The amendments made by 8 this section and section 2 shall take effect on the date 9 that is 180 days after the date of enactment of this Act. 10 SEC. 4. GAO REPORT ON INTRA-AGENCY COORDINATION. 11 (a) IN GENERAL.—Not later than 18 months after 12 the date of enactment of this Act, the Comptroller General 13 of the United States shall submit to the Committee on 14 Health, Education, Labor, and Pensions of the Senate and 15 the Committee on Energy and Commerce of the House 16 of Representatives a report examining the Food and Drug 17 Administration’s intra-agency coordination, communica- 18 tion, and decision making in assessing drug shortage risks, 19 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 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 7 •S 2723 IS (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 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 8 •S 2723 IS SEC. 5. MODIFICATIONS TO DRUG SHORTAGE LIST MAIN- 1 TAINED BY FDA. 2 (a) IN GENERAL.—Section 506E of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 356e) is amend- 4 ed— 5 (1) in subsection (a), by striking the period and 6 inserting the following: ‘‘, by region, including States 7 and localities, where the shortages exist. The Sec- 8 retary may enter into a private-public partnership to 9 maintain such list.’’; and 10 (2) in subsection (b)(3)(C), by inserting before 11 the period the following: ‘‘, strength, or dosage 12 form’’. 13 (b) EFFECTIVE DATE.—The amendments made by 14 subsection (a) shall take effect on the date of enactment 15 of this Act, and shall apply to updates made to the drug 16 shortage list under section 506E of the Federal Food, 17 Drug, and Cosmetic Act after the date of enactment of 18 this Act. 19 SEC. 6. NATIONAL SECURITY RISK ASSESSMENT OF DRUG, 20 ACTIVE PHARMACEUTICAL INGREDIENT AND 21 MEDICAL DEVICE MANUFACTURING OPER- 22 ATIONS. 23 (a) ASSESSMENT AND REPORT.— 24 (1) IN GENERAL.—The Secretary of Health and 25 Human Services, in collaboration with the Secretary 26 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 9 •S 2723 IS of Homeland Security and in consultation with 1 stakeholders (including pharmacists, hospitals, phy- 2 sicians, and pharmaceutical and medical device man- 3 ufacturers), shall conduct a risk assessment of na- 4 tional security threats arising from, or related to, 5 the manufacture and distribution of drugs described 6 in 506C(a) of the Federal Food, Drug, and Cosmetic 7 Act (21 U.S.C. 356c(a)) or of any active pharma- 8 ceutical ingredients of such drugs or associated med- 9 ical devices used for preparation or administration of 10 such drugs. Not later than 18 months after the date 11 of enactment of this Act, the Secretary shall submit 12 to the Committee on Health, Education, Labor, and 13 Pensions of the Senate and the Committee on En- 14 ergy and Commerce of the House of Representatives 15 a report outlining findings under such assessment 16 and any recommended actions. 17 (2) CONTENT.—The assessment and report 18 under paragraph (1) shall include— 19 (A) a review of manufacturing and dis- 20 tribution of drugs described in such section 21 506C(a), active pharmaceutical ingredients of 22 such drugs, and associated medical devices used 23 for preparation or administration of such drugs, 24 that includes consideration of whether manufac- 25 VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS 10 •S 2723 IS turing sites and distribution systems should be 1 considered critical infrastructure (as defined in 2 section 1016(e) of the Critical Infrastructures 3 Protection Act of 2001 (42 U.S.C. 5195c(e))); 4 (B) a review of risks associated with the 5 foreign manufacture of such drugs, ingredients, 6 or devices; and 7 (C) recommendations on how to mitigate 8 any such risks. 9 (b) STANDING FORUM.—The Secretary of Health 10 and Human Services, in collaboration with the Secretary 11 of Homeland Security, shall establish a standing forum 12 to engage stakeholders, including pharmacists, hospitals, 13 physicians, and pharmaceutical and medical device manu- 14 facturers, to mitigate risks identified through the assess- 15 ment conducted under subsection (a). 16 Æ VerDate Sep 11 2014 03:26 Oct 31, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S2723.IS S2723 kjohnson on DSK79L0C42 with BILLS