Secure America’s Medicine Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 8644 To ensure the availability of critical medications in the event of public health emergencies, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 20, 2020 Mr. SMITH of Missouri (for himself and Mr. SCHNEIDER) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To ensure the availability of critical medications in the event of public health emergencies, 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; SENSE OF CONGRESS. 3 This Act may be cited as the ‘‘Secure America’s Med- 4 icine Act of 2020’’. 5 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 8644 IH SEC. 2. ENSURING THE AVAILABILITY OF CRITICAL MEDI- 1 CATIONS IN THE EVENT OF PUBLIC HEALTH 2 EMERGENCIES. 3 (a) IN GENERAL.—The Public Health Service Act is 4 amended by inserting after section 319F–4 of such Act 5 (42 U.S.C. 247d–6e) the following new section: 6 ‘‘SEC. 319F–5. ENSURING THE AVAILABILITY OF CRITICAL 7 MEDICATIONS IN THE EVENT OF PUBLIC 8 HEALTH EMERGENCIES. 9 ‘‘(a) LIST OF CRITICAL MEDICATIONS.— 10 ‘‘(1) IN GENERAL.—The Secretary shall main- 11 tain a list of medications (in this section referred to 12 as ‘critical medications’) with respect to which it is 13 critical that the Federal Government ensure avail- 14 ability in the event of a public health emergency. 15 ‘‘(2) COLLABORATION.—The Secretary shall 16 carry out this subsection and subsection (b) in col- 17 laboration with the Assistant Secretary for Pre- 18 paredness and Response, the Commissioner of Food 19 and Drugs, the Director of the Centers for Disease 20 Control and Prevention, and the Secretary of Home- 21 land Security. 22 ‘‘(3) TIMING OF LIST; REPORTING.—The Sec- 23 retary shall— 24 ‘‘(A) not later than 180 days after the date 25 of the enactment of the this section— 26 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 8644 IH ‘‘(i) establish the initial list required 1 by paragraph (1); 2 ‘‘(ii) submit a report, in a manner 3 that does not compromise national secu- 4 rity, to the Committee on Appropriations 5 and the Committee on Energy and Com- 6 merce of the House of Representatives and 7 the Committee on Appropriations and the 8 Committee on Health, Education, Labor, 9 and Pensions of the Senate, setting 10 forth— 11 ‘‘(I) the list in effect under para- 12 graph (1); 13 ‘‘(II) the reasons why each crit- 14 ical medication is included on the list; 15 ‘‘(III) the reasons why other 16 medications described in paragraph 17 (4) were not included; and 18 ‘‘(IV) which critical medications 19 are designated critical medications 20 under subsection (b) and the reasons 21 for each such designation; and 22 ‘‘(iii) make publicly available the list 23 in effect under paragraph (1) and the most 24 recent report under clause (ii), subject to 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 8644 IH any redactions or edits necessary to re- 1 move classified information or otherwise 2 ensure that national security is not com- 3 promised; and 4 ‘‘(B) not later than March 15 of each year 5 following the year in which the first list of crit- 6 ical medications is required by paragraph (1)— 7 ‘‘(i) update the list required by para- 8 graph (1); 9 ‘‘(ii) submit an updated report under 10 subparagraph (A)(ii); and 11 ‘‘(iii) make publicly available such up- 12 dated list and report in accordance with 13 subparagraph (A)(iii). 14 ‘‘(4) REQUIRED INCLUSION ON LIST.—Subject 15 to paragraph (5), the Secretary shall include on the 16 list under paragraph (1) the following medications: 17 ‘‘(A) Commonly-used medications likely to 18 be needed in order to prevent, mitigate, or treat 19 the adverse health effects which frequently re- 20 sult from a public health emergency, including 21 medications routinely needed to effectively man- 22 age patients in hospital emergency rooms or in- 23 tensive care units, and medications needed dur- 24 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 8644 IH ing surgical procedures often required during a 1 public health emergency. 2 ‘‘(B) Anti-infective medications, including 3 antibiotic, antifungal, and antiviral medications, 4 which are either commonly used to treat infec- 5 tious diseases or have a significant likelihood of 6 being needed to treat an infectious disease that, 7 if not so treated, may result in a public health 8 emergency. 9 ‘‘(C) Commonly-used medications which 10 are life-supporting, life-sustaining, or intended 11 for the use in the prevention or treatment of a 12 debilitating disease or condition, as such terms 13 are defined in section 506C of the Federal 14 Food, Drug, and Cosmetics Act and the regula- 15 tions thereunder. 16 ‘‘(5) LIMITATIONS ON INCLUSION ON LIST.— 17 The Secretary— 18 ‘‘(A) shall not be required to include on 19 the list under paragraph (1) every medication 20 meeting the criteria described in paragraph (4); 21 ‘‘(B) shall prioritize the inclusion on the 22 list under paragraph (1) of 300 to 400 medica- 23 tions meeting such criteria— 24 ‘‘(i) that are most commonly used; or 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 8644 IH ‘‘(ii) for which a shortage would be 1 most likely to have the greatest potential 2 adverse health consequences; 3 ‘‘(C) in applying subparagraph (B), shall 4 count as a single medication— 5 ‘‘(i) all strengths, dosage forms, and 6 package forms of a given medication; 7 ‘‘(ii) medications that are therapeuti- 8 cally equivalent (under the Food and Drug 9 Administration’s most recent publication of 10 ‘Approved Drug Products with Therapeutic 11 Equivalence Evaluations’); and 12 ‘‘(iii) a biological product licensed 13 under section 351(a) and all biosimilar bio- 14 logical products that are licensed under 15 section 351(k) using the biological product 16 as the reference product; and 17 ‘‘(D) in applying subparagraph (B), shall 18 not prioritize the inclusion of any medication 19 that is a qualified countermeasure (as defined 20 in section 319F–1(a)(2)), a security counter- 21 measure (as defined in section 319F– 22 2(c)(1)(B)), or a qualified pandemic and epi- 23 demic product (as defined in section 319F– 24 3(i)). 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 8644 IH ‘‘(6) PUBLIC INPUT AND COMMENT.—In devel- 1 oping and updating the list under paragraph (1), the 2 Secretary shall solicit public input, including by— 3 ‘‘(A) consulting (through public meetings 4 or other forms of engagement) with relevant 5 stakeholders, including health care providers, 6 medical professional societies, public health ex- 7 perts, State and local public health depart- 8 ments, patient groups, and drug manufacturers 9 and distributors; 10 ‘‘(B) publishing in the Federal Register, 11 for public review and comment, the Secretary’s 12 proposed list of critical medications, together 13 with the Secretary’s reasons why each medica- 14 tion included on such proposed list was included 15 and the reasons why other medications were not 16 included; 17 ‘‘(C) accepting public comment on such 18 proposed list and reasons for a period of not 19 less than 60 days; 20 ‘‘(D) taking such comments into account 21 in determining the final list under paragraph 22 (1); and 23 ‘‘(E) addressing such comments in report- 24 ing under paragraph (3). 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 8644 IH ‘‘(7) ADDITIONAL CONSIDERATIONS.—In devel- 1 oping and updating the list under paragraph (1), the 2 Secretary shall consider— 3 ‘‘(A) the most recent annual threat-based 4 review conducted by the Secretary under section 5 319F–2(a)(2), the most recent report of the 6 Comptroller General of the United States under 7 section 319F–2(a)(5), and the most recent rec- 8 ommendations of the Public Health Emergency 9 Countermeasures Enterprise established under 10 section 2811–1; 11 ‘‘(B) input from each member of the Pub- 12 lic Health Emergency Countermeasures Enter- 13 prise (or a designee thereof); and 14 ‘‘(C) if available, the report of the National 15 Academies of Sciences, Engineering, and Medi- 16 cine prepared pursuant to section 3101 of the 17 Coronavirus Aid, Relief, and Economic Stability 18 Act (Public Law 116–136). 19 ‘‘(b) DESIGNATION OF CRITICAL MEDICATIONS FOR 20 WHICH AVAILABILITY IS AT RISK IN THE EVENT OF A 21 PUBLIC HEALTH EMERGENCY.— 22 ‘‘(1) IN GENERAL.—The Secretary shall— 23 ‘‘(A) evaluate each critical medication to 24 determine whether there is adequate assurance 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 8644 IH that it will be available in sufficient quantities 1 in the event of a public health emergency, on a 2 timely basis, within each portion of the United 3 States where it is needed; and 4 ‘‘(B) designate each critical medication 5 with respect to which the Secretary determines 6 there is not such an adequate assurance. 7 ‘‘(2) FACTORS TO BE TAKEN INTO ACCOUNT.— 8 In carrying out paragraph (1), the Secretary shall 9 take into account factors including— 10 ‘‘(A) volume inventories of each critical 11 medication that are normally available for use 12 in the United States, in the public and private 13 sector, in the absence of a public health emer- 14 gency; 15 ‘‘(B) current and expected production ca- 16 pacity, in the United States and in foreign 17 countries, of each critical medication, including 18 the domestic and foreign capacity to surge pro- 19 duction of each critical medication and the time 20 required to do so, taking into account, among 21 other things, current marketplace trends and 22 factors and the economic viability of creating 23 and maintaining such surge capacity in the ab- 24 sence of nonemergency commercial demand; 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 8644 IH ‘‘(C) the potential demand and historic de- 1 mand trends for each critical medication in the 2 event of a public health emergency, including 3 demand in the United States and in foreign 4 countries; and 5 ‘‘(D) potential constraints on the timely 6 manufacture and distribution of each critical 7 medication in sufficient quantities for each por- 8 tion of the United States where it is needed in 9 the event of public health emergency, including 10 constraints due to the unavailability or limited 11 availability of such critical medication or any 12 key ingredients thereof (including active phar- 13 maceutical ingredients) from one or more for- 14 eign countries. 15 ‘‘(3) CONDUCT OF EVALUATION.—In carrying 16 out paragraph (1), the Secretary may consider such 17 other factors as the Secretary considers relevant to 18 determining the supply chain vulnerability of each 19 critical medication and each key ingredient thereof 20 (including active pharmaceutical ingredients) in the 21 event of a public health emergency, which may in- 22 clude— 23 ‘‘(A) whether and to what extent the exist- 24 ing sources of such supply for the United 25 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 8644 IH States are domestic or foreign, the specific for- 1 eign countries from which any such foreign sup- 2 ply is obtained and in what quantities, and the 3 extent of the risk of a disruption in supply from 4 each such foreign country in the event of a pub- 5 lic health emergency; 6 ‘‘(B) the location of each domestic and for- 7 eign establishment registered under section 510 8 of the Federal Food, Drug, and Cosmetic Act 9 and identified in such registration as manufac- 10 turing, preparing, propagating, or compounding 11 such critical medication or a key ingredient 12 thereof, as well as, for each such establishment, 13 the current and historical production thereof 14 and the current production capacity thereof; 15 ‘‘(C) the likelihood of continued or in- 16 creased production from each domestic and for- 17 eign establishment referenced in subparagraph 18 (B), and the timeframe necessary for any in- 19 crease in production, taking into account regu- 20 latory, logistical, economic, and other relevant 21 factors; and 22 ‘‘(D) any economic, regulatory, or other 23 impediments to domestic production thereof. 24 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 8644 IH ‘‘(4) TIMEFRAME FOR DESIGNATION AND RE- 1 EVALUATION.—The Secretary shall— 2 ‘‘(A) determine whether to designate a 3 critical medication under paragraph (1) not 4 later than 90 days after the earlier of— 5 ‘‘(i) the date that such medication was 6 first proposed by the Secretary to be a 7 critical medication through publication in 8 the Federal Register in accordance with 9 subsection (a)(4)(B); or 10 ‘‘(ii) the date that such medication be- 11 came a critical medication pursuant to the 12 final determination of the Secretary in ac- 13 cordance with subsection (a)(1)(A); or 14 ‘‘(B) not later than March 15 each year, 15 reevaluate in accordance with paragraph (1)(A) 16 each designation in effect under paragraph 17 (1)(B). 18 ‘‘(5) PUBLIC INPUT AND FACTORS TO BE CON- 19 SIDERED.—In carrying out paragraph (1), the Sec- 20 retary shall— 21 ‘‘(A) consult with relevant stakeholders, in- 22 cluding those described in subsection (a)(6)(A); 23 VerDate Sep 11 2014 18:38 Nov 06, 2020 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H8644.IH H8644 pamtmann on DSKBC07HB2PROD with BILLS 13 •HR 8644 IH ‘‘(B) consider the annual threat-based re- 1 view and reports referenced in and input re- 2 ceived under subsection (a)(7); and 3 ‘‘(C) consult with experts in medication 4 production, distribution, and demand, including 5 economists or other analysts with expe [Text truncated for display. 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