Securing America’s Medicine Cabinet Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 70 To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JANUARY 4, 2021 Mr. BUCHANAN introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To support the advanced manufacturing technologies pro- gram of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharma- ceutical Manufacturing, 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 ‘‘Securing America’s 4 Medicine Cabinet Act of 2021’’. 5 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 70 IH SEC. 2. ADVANCED MANUFACTURING TECHNOLOGIES PRO- 1 GRAM. 2 Subchapter A of chapter V of the Federal Food, 3 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend- 4 ed by adding at the end the following: 5 ‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 6 PROGRAM. 7 ‘‘(a) IN GENERAL.—Not later than 1 year after the 8 date of enactment of the Securing America’s Medicine 9 Cabinet Act of 2021, the Secretary shall continue in effect 10 the program to evaluate and approve new drug manufac- 11 turing technologies that are included in an application, or 12 supplement to an application, for a drug under subsection 13 (b) or (j) of section 505 of this Act or for a biological 14 product submitted under subsection (a) or (k) of section 15 351 of the Public Health Service Act. 16 ‘‘(b) DESIGNATION.—The Secretary shall designate a 17 method of manufacturing a drug as an advanced manufac- 18 turing technology under this section if the drug manufac- 19 turer demonstrates that such technology is likely to— 20 ‘‘(1) prevent or resolve a drug shortage; 21 ‘‘(2) maintain an adequate supply of critical 22 medications for national emergencies; or 23 ‘‘(3) promote the adoption of innovative ap- 24 proaches to drug product design and manufacturing. 25 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 70 IH ‘‘(c) CONSULTATION.—If the Secretary designates a 1 method of manufacturing as an advanced manufacturing 2 technology under this section, the Secretary shall take ac- 3 tions to expedite the development and implementation of 4 such method of manufacture for purposes of approval of 5 the application under subsection (c) or (j) of section 505 6 of this Act or subsection (a) or (k) of section 351 of the 7 Public Health Service Act, which may include, as appro- 8 priate— 9 ‘‘(1) holding meetings between the sponsor of 10 the application and appropriate Food and Drug Ad- 11 ministration staff throughout the development of the 12 technology; 13 ‘‘(2) providing timely advice to, and interactive 14 communication with, the sponsor regarding the de- 15 velopment of the technology; and 16 ‘‘(3) involving senior managers and experienced 17 staff of the Food and Drug Administration, as ap- 18 propriate, in a collaborative, cross-disciplinary review 19 of the method of manufacturing. 20 ‘‘(d) EVALUATION OF AN ADVANCED MANUFAC- 21 TURING TECHNOLOGY.— 22 ‘‘(1) PACKAGE.—A sponsor who receives des- 23 ignation of an advanced manufacturing technology 24 under this section shall provide the Secretary with a 25 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 70 IH package of scientific evidence supporting the imple- 1 mentation of the advanced manufacturing technology 2 in a particular context-of-use. 3 ‘‘(2) EVALUATION.—Within 90 days of receiv- 4 ing the package, the Secretary shall determine 5 whether a designated advanced manufacturing tech- 6 nology is validated for the proposed context of use 7 based on the scientific merit the supporting evidence 8 provided by the sponsor. 9 ‘‘(3) EFFECT OF APPROVAL.—Upon approval, 10 the same sponsor may rely upon the advanced man- 11 ufacturing technology for use across multiple manu- 12 facturing product lines within the same context-of- 13 use without having to re-submit data to the Sec- 14 retary validating the underlying technology. 15 ‘‘(e) IMPLEMENTATION AND REPORTING.— 16 ‘‘(1) PUBLIC MEETING.—The Secretary shall 17 publish in the Federal Register a notice of a public 18 meeting to be held no later than 1 year after the 19 date of enactment of the Securing America’s Medi- 20 cine Cabinet Act of 2021 to discuss and obtain input 21 and recommendations from stakeholders regarding 22 the goals and scope of, and a suitable framework 23 and procedures and requirements for, the program 24 under this section. 25 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 70 IH ‘‘(2) PROGRAM GUIDANCE.—The Secretary 1 shall— 2 ‘‘(A) not later than 1 year after the date 3 of enactment of the Securing America’s Medi- 4 cine Cabinet Act of 2021, issue draft guidance 5 regarding the goals and implementation of the 6 program under this section; and 7 ‘‘(B) not later than 2 years after the date 8 of enactment of the Securing America’s Medi- 9 cine Cabinet Act of 2021, issue final guidance 10 with respect to the implementation of such pro- 11 gram. 12 ‘‘(3) REPORT.—The Secretary shall make avail- 13 able on the internet website of the Food and Drug 14 Administration an annual report on the progress of 15 the program under this section.’’. 16 SEC. 3. NATIONAL CENTER OF EXCELLENCE IN ADVANCED 17 PHARMACEUTICAL MANUFACTURING. 18 Chapter X of the Federal Food, Drug, and Cosmetic 19 Act (21 U.S.C. 391 et seq.) is amended by adding at the 20 end the following: 21 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 70 IH ‘‘SEC. 1015. NATIONAL CENTER OF EXCELLENCE IN AD- 1 VANCED PHARMACEUTICAL MANUFAC- 2 TURING. 3 ‘‘(a) IN GENERAL.—The Secretary shall designate in- 4 stitutions of higher education as National Centers of Ex- 5 cellence in Advanced Pharmaceutical Manufacturing, in- 6 cluding continuous pharmaceutical manufacturing. 7 ‘‘(b) ELIGIBILITY.—To be eligible for designation 8 under subsection (a) an entity shall— 9 ‘‘(1) be an institution of higher education; 10 ‘‘(2) demonstrate— 11 ‘‘(A) the physical and technical capacity 12 for research and development of advanced phar- 13 maceutical manufacturing; 14 ‘‘(B) a record of transferring scientific 15 knowledge to the marketplace; 16 ‘‘(C) scalable manufacturing knowledge, 17 which may be through collaborations of other 18 institutions of higher education, biopharma- 19 ceutical manufacturers, or other entities; 20 ‘‘(D) the ability to train a future workforce 21 for research on and implementation of advanced 22 pharmaceutical manufacturing; and 23 ‘‘(E) the ability to support Federal agen- 24 cies with technical assistance for advanced 25 pharmaceutical technologies, with an emphasis 26 VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 70 IH on creating a secure national pharmaceutical 1 stockpile and the ability to rapidly address drug 2 shortages; and 3 ‘‘(3) submit an application to the Secretary at 4 such time, in such form, and in such manner as the 5 Secretary may require. 6 ‘‘(c) TERMINATION.—The Secretary may terminate 7 the designation of an entity designated under subsection 8 (a) upon a determination that the entity no longer meets 9 the requirements of subsection (b). 10 ‘‘(d) ANNUAL REPORT.—Not later than 1 year after 11 the date on which the first designation is made under sub- 12 section (a), and annually thereafter, the Secretary shall 13 submit a report to Congress on the activities of the entities 14 designated under such subsection. 15 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 16 carry out this section, there are authorized to be appro- 17 priated $100,000,000 for the period of fiscal years 2022 18 through 2025.’’. 19 Æ VerDate Sep 11 2014 19:39 Jan 12, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H70.IH H70 pamtmann on DSKBC07HB2PROD with BILLS