To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes.

I 116TH CONGRESS 2D SESSION H. R. 6062 To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life- saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 3, 2020 Mr. SCHNEIDER (for himself, Mr. HICE of Georgia, and Ms. SCHAKOWSKY) introduced the following bill; which was referred to the Committee on En- ergy and Commerce A BILL To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or inter- ruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, 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. DISCONTINUANCE OR INTERRUPTION IN THE 3 PRODUCTION OF LIFE-SAVING DEVICES. 4 (a) NOTIFICATION REQUIREMENT.—Section 506C of 5 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 6 356c) is amended— 7 VerDate Sep 11 2014 20:51 Mar 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 6062 IH (1) in the section heading, by striking ‘‘LIFE- 1 SAVING DRUGS’’ and inserting ‘‘LIFE-SAVING 2 DRUGS AND DEVICES’’; 3 (2) in the matter preceding paragraph (1) in 4 subsection (a), by striking ‘‘a drug’’ and inserting ‘‘a 5 drug or device’’; 6 (3) in subsection (a)(1)(C), by striking ‘‘such 7 drug’’ and inserting ‘‘such drug or device’’; 8 (4) in the matter following paragraph (2) in 9 subsection (a), by striking ‘‘the drug’’ each place it 10 appears and inserting ‘‘the drug or device’’; 11 (5) in subsection (c), by striking ‘‘the drugs’’ 12 and inserting ‘‘the drugs or devices’’; 13 (6) in the matter before paragraph (1) in sub- 14 section (g), by striking ‘‘a drug shortage of a drug 15 described in subsection (a)’’ and inserting ‘‘a drug 16 or device shortage of a drug or device described in 17 subsection (a)’’; 18 (7) in subsection (g)(1), by striking ‘‘or a sup- 19 plement to such an application submitted under sec- 20 tion 505(j), that could help mitigate or prevent such 21 shortage’’ and inserting ‘‘a supplement to such an 22 application submitted under section 505(j), or a sub- 23 mission for clearance of a device under section 24 510(k), classification of a device under section 25 VerDate Sep 11 2014 20:51 Mar 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 6062 IH 513(f)(2), or approval of a device under section 515, 1 that could help mitigate or prevent such shortage’’; 2 (8) in subsection (g)(2), by striking ‘‘such drug 3 shortage’’ and inserting ‘‘such drug or device short- 4 age’’; 5 (9) in subsection (h), by amending paragraph 6 (2) to read as follows: 7 ‘‘(2) the term ‘drug or device shortage’ or 8 ‘shortage’, with respect to a drug or device, means 9 a period of time when the demand or projected de- 10 mand for the drug or device within the United 11 States exceeds the supply of the drug or device; 12 and’’; and 13 (10) in subsection (h)(3)(A), by striking ‘‘a 14 drug’’ and inserting ‘‘a drug or device’’. 15 (b) ANNUAL REPORTING ON SHORTAGES.—Section 16 506C–1 of the Federal Food, Drug, and Cosmetic Act (21 17 U.S.C. 356c–1) is amended— 18 (1) in the section heading, by striking ‘‘DRUG 19 SHORTAGES’’ and inserting ‘‘DRUG AND DEVICE 20 SHORTAGES’’; 21 (2) in subsections (a) and (b), by striking 22 ‘‘drug shortages’’ each place it appears and inserting 23 ‘‘drug and device shortages’’; 24 VerDate Sep 11 2014 20:51 Mar 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 6062 IH (3) in subsection (a)(2), by striking ‘‘the staff 1 of the Center for Drug Evaluation and Research’s 2 Office of Compliance and Drug Shortage Program’’ 3 and inserting ‘‘the staffs of the Center for Drug 4 Evaluation and Research’s Office of Compliance and 5 Drug Shortage Program and the Center for Devices 6 and Radiological Health’’; 7 (4) in subsection (a)(3)(B)(i), by striking ‘‘ap- 8 plications and supplements’’ and inserting ‘‘applica- 9 tions, supplements, and submissions’’; and 10 (5) in subsections (a)(5) and (c), by striking 11 ‘‘drug shortage’’ and inserting ‘‘drug or device 12 shortage’’. 13 SEC. 2. DEVICE SHORTAGE LIST. 14 (a) IN GENERAL.—Section 506E of the Federal 15 Food, Drug, and Cosmetic Act (21 U.S.C. 356e) is amend- 16 ed— 17 (1) in the section heading, by striking ‘‘DRUG 18 SHORTAGE LIST’’ and inserting ‘‘DRUG AND DE- 19 VICE SHORTAGE LIST’’; and 20 (2) in subsection (a), by striking ‘‘list of drugs’’ 21 and inserting ‘‘list of drugs and devices’’. 22 (b) CONTENTS.—Section 506E(b) of the Federal 23 Food, Drug, and Cosmetic Act (21 U.S.C. 356e(b)) is 24 amended— 25 VerDate Sep 11 2014 20:47 Mar 06, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 6062 IH (1) in the matter before paragraph (1), by 1 striking ‘‘each drug’’ and inserting ‘‘each drug and 2 device’’; 3 (2) by striking ‘‘the drug’’ each place it appears 4 and inserting ‘‘the drug or device’’; 5 (3) in paragraph (1), by striking ‘‘the National 6 Drug Code number for such drug’’ and inserting 7 ‘‘the National Drug Code number for any such 8 drug’’; and 9 (4) in paragraph (2), by striking ‘‘such drug’’ 10 and inserting ‘‘such device’’. 11 (c) PUBLIC AVAILABILITY PUBLIC HEALTH EXCEP- 12 TION.—Section 506E(c) of the Federal Food, Drug, and 13 Cosmetic Act (21 U.S.C. 356e(b)) is amended by striking 14 ‘‘drug products’’ and inserting ‘‘drug products or devices’’. 15 (d) TECHNICAL CORRECTIONS.—Effective as if in- 16 cluded in the enactment of the 21st Century Cures Act 17 (Public Law 114–255), section 3101(a)(2)(G) of such Act 18 is amended, in the amendments made by such section to 19 section 506E(b)(3)(E) of the Federal Food, Drug, and 20 Cosmetic Act (21 U.S.C. 356e(b)(3)(E))— 21 (1) by striking ‘‘discontinuation’’ and inserting 22 ‘‘Discontinuation’’; and 23 (2) by striking ‘‘discontinuance’’ and inserting 24 ‘‘Discontinuance’’. 25 VerDate Sep 11 2014 20:51 Mar 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 6062 IH SEC. 3. IMPORTATION OF DEVICES IN SHORTAGE. 1 Section 801(d) of the Federal Food, Drug, and Cos- 2 metic Act (21 U.S.C. 381(d)) is amended— 3 (1) in paragraph (1), by adding at the end the 4 following subparagraph: 5 ‘‘(C) Except as authorized by the Secretary in the 6 case of a device that appears on the drug and device short- 7 age list under section 506E, no device may be imported 8 into the United States for commercial use if such device 9 is manufactured outside the United States, unless the 10 manufacturer has authorized the device to be marketed 11 in the United States and has caused the device to be la- 12 beled to be marketed in the United States.’’; and 13 (2) in paragraph (2), by striking ‘‘drug’’ each 14 place it appears and inserting ‘‘drug or device’’. 15 Æ VerDate Sep 11 2014 20:51 Mar 05, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H6062.IH H6062 pamtmann on DSKBC07HB2PROD with BILLS