LOSS Act of 202

I 116TH CONGRESS 2D SESSION H. R. 6660 To amend the Federal Food, Drug, and Cosmetic Act to require the holders of approved applications for drugs to conduct a risk assessment to identify and evaluate risks to their supply chain and develop, maintain, and implement risk mitigation plans to address such risks, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 1, 2020 Ms. BLUNT ROCHESTER (for herself and Mr. CARTER of Georgia) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to require the holders of approved applications for drugs to conduct a risk assessment to identify and evaluate risks to their supply chain and develop, maintain, and implement risk mitigation plans to address such risks, 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 VerDate Sep 11 2014 17:33 May 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 6660 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Limit Ongoing Short- 2 ages and Stabilize Supply Act of 2020’’ or the ‘‘LOSS 3 Act of 2020’’. 4 SEC. 2. RISK ASSESSMENTS AND RISK MITIGATION PLANS 5 FOR DRUGS. 6 (a) IN GENERAL.—The Federal Food, Drug, and 7 Cosmetic Act is amended by inserting after section 506C– 8 1 of such Act (21 U.S.C. 356c–1) the following new sec- 9 tion: 10 ‘‘SEC. 506C–2. RISK ASSESSMENTS AND RISK MITIGATION 11 PLANS FOR DRUGS. 12 ‘‘(a) COVERED DRUG DEFINED.—In this section, the 13 term ‘covered drug’— 14 ‘‘(1) means a drug that— 15 ‘‘(A) is described in section 506C(a); or 16 ‘‘(B) is included, or was included at any 17 point during the preceding 5 years, in the drug 18 shortage list in effect under section 506E; and 19 ‘‘(2) includes any such drug that is not required 20 to be approved pursuant to an application under 21 subsection (b) or (j) of section 505 of this Act or 22 subsection (a) or (k) of section 351 of the Public 23 Health Service Act to be lawfully marketed. 24 ‘‘(b) REQUIREMENT.—The manufacturer of a covered 25 drug shall— 26 VerDate Sep 11 2014 17:33 May 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 6660 IH ‘‘(1) conduct a risk assessment that identifies 1 and evaluates risks to the supply of the drug, includ- 2 ing vulnerabilities that would likely lead to a mean- 3 ingful disruption in the supply of the drug in the 4 United States; 5 ‘‘(2) develop and maintain a risk mitigation 6 plan to ensure the supply of the drug during such 7 a shortage; and 8 ‘‘(3) implement such plan during such a short- 9 age. 10 ‘‘(c) CONFIDENTIALITY.—The Secretary shall— 11 ‘‘(1) maintain the confidentiality of any risk as- 12 sessment, and any risk mitigation plan, under this 13 section; and 14 ‘‘(2) limit the use by the Secretary of informa- 15 tion in such an assessment or plan to preventing, 16 mitigating, or responding to a drug shortage. 17 ‘‘(d) GUIDANCE.—The Secretary shall publish guid- 18 ance on— 19 ‘‘(1) how manufacturers should work with their 20 supply chain partners in developing the required risk 21 assessments and risk mitigation plans; 22 ‘‘(2) the elements of a risk mitigation plan 23 under this section; and 24 VerDate Sep 11 2014 17:33 May 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 6660 IH ‘‘(3) the form and manner of developing and 1 maintaining such plan. 2 ‘‘(e) INSPECTION.—A risk mitigation plan under this 3 section shall be subject to inspection and copying by the 4 Secretary under section 704. 5 ‘‘(f) EXPEDITED INSPECTIONS AND REVIEWS.—The 6 Secretary may conduct an expedited inspection or review 7 as described in section 506C(g) for the purpose of facili- 8 tating the implementation of a risk management plan de- 9 veloped pursuant to this section.’’. 10 (b) PROHIBITED ACT.—Section 301 of the Federal 11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend- 12 ed by adding at the end the following: 13 ‘‘(fff) The failure to conduct a risk assessment, or 14 to develop, maintain, and implement a risk mitigation 15 plan, in accordance with section 506C–2.’’. 16 (c) APPLICABILITY.—The amendments made by this 17 section apply beginning on the date that is 24 months 18 after the date of enactment of this Act, except that the 19 Secretary of Health and Human Services, acting through 20 the Commissioner of Food and Drugs, shall have discre- 21 tion to allow persons subject to such amendments addi- 22 tional time to comply with such amendments as the Sec- 23 retary determines necessary. 24 VerDate Sep 11 2014 01:22 May 07, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 6660 IH SEC. 3. DISCONTINUANCE OR INTERRUPTION IN PRODUC- 1 TION. 2 (a) ACTIVE PHARMACEUTICAL INGREDIENTS.— 3 (1) ACTIVE PHARMACEUTICAL INGREDIENTS.— 4 Section 506C of the Federal Food, Drug, and Cos- 5 metic Act (21 U.S.C. 356c) is amended by adding 6 at the end the following: 7 ‘‘(j) APPLICABILITY WITH RESPECT TO ACTIVE 8 PHARMACEUTICAL INGREDIENTS.—This section shall 9 apply with respect to an active pharmaceutical ingredient 10 in a drug described in subsection (a) in the same manner 11 and to the same extent as this section applies with respect 12 to a drug described in subsection (a), except that sub- 13 section (i) shall not apply with respect to active pharma- 14 ceutical ingredients.’’. 15 (2) GUIDANCE.— 16 (A) ISSUANCE.—Not later than 24 months 17 after the date of enactment of this Act, the Sec- 18 retary of Health and Human Services, acting 19 through the Commissioner of Food and Drugs, 20 shall issue final guidance on implementing the 21 amendment made by paragraph (1). 22 (B) CONTENTS.—The guidance required 23 by subparagraph (A) shall specify— 24 VerDate Sep 11 2014 17:33 May 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 6660 IH (i) the form and manner of the disclo- 1 sures required by the amendment made by 2 paragraph (1); and 3 (ii) the details that need to be in- 4 cluded in such disclosures. 5 (b) PROHIBITED ACTS WITH RESPECT TO DRUGS 6 AND ACTIVE PHARMACEUTICAL INGREDIENTS.—Section 7 301 of the Federal Food, Drug, and Cosmetic Act (21 8 U.S.C. 331), as amended by section 2(b), is further 9 amended by adding at the end the following: 10 ‘‘(ggg) The failure of a manufacturer of a drug de- 11 scribed in section 506C(a) or an active pharmaceutical in- 12 gredient of such a drug, without a reasonable basis as de- 13 termined by the Secretary, to notify the Secretary of a 14 permanent discontinuance or an interruption, and the rea- 15 sons for such discontinuance or interruption, as required 16 by section 506C.’’. 17 (c) APPLICABILITY.—The amendments made by sub- 18 sections (a) and (b) apply beginning on the date that is 19 180 days after the date of enactment of this Act. 20 Æ VerDate Sep 11 2014 17:33 May 05, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H6660.IH H6660 pamtmann on DSKBC07HB2PROD with BILLS