Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021

II 117TH CONGRESS 1ST SESSION S. 154 To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other pur- poses. IN THE SENATE OF THE UNITED STATES FEBRUARY 2, 2021 Mr. CRUZ (for himself, Mr. JOHNSON, and Ms. ERNST) introduced the fol- lowing 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 provide for reciprocal marketing approval of certain drugs, biological products, and devices that are author- ized to be lawfully marketed abroad, and for other pur- poses. 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 ‘‘Reciprocity Ensures 4 Streamlined Use of Lifesaving Treatments Act of 2021’’. 5 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 154 IS SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN 1 DRUGS, BIOLOGICAL PRODUCTS, AND DE- 2 VICES. 3 The Federal Food, Drug, and Cosmetic Act is amend- 4 ed by inserting after section 524A of such Act (21 U.S.C. 5 360n–1) the following: 6 ‘‘SEC. 524B. RECIPROCAL MARKETING APPROVAL. 7 ‘‘(a) IN GENERAL.—A covered product with recip- 8 rocal marketing approval in effect under this section is 9 deemed to be subject to an application or premarket notifi- 10 cation for which an approval or clearance is in effect under 11 section 505(c), 510(k), or 515 of this Act or section 12 351(a) of the Public Health Service Act, as applicable. 13 ‘‘(b) ELIGIBILITY.—The Secretary shall, with respect 14 to a covered product, grant reciprocal marketing approval 15 if— 16 ‘‘(1) the sponsor of the covered product submits 17 a request for reciprocal marketing approval; and 18 ‘‘(2) the request demonstrates to the Sec- 19 retary’s satisfaction that— 20 ‘‘(A) the covered product is authorized to 21 be lawfully marketed in one or more of the 22 countries included in the list under section 23 802(b)(1) or in the United Kingdom; 24 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 154 IS ‘‘(B) absent reciprocal marketing approval, 1 the covered product is not approved or cleared 2 for marketing, as described in subsection (a); 3 ‘‘(C) the Secretary has not, because of any 4 concern relating to the safety or effectiveness of 5 the covered product, rescinded or withdrawn 6 any such approval or clearance; 7 ‘‘(D) the authorization to market the cov- 8 ered product in one or more of the countries in- 9 cluded in the list under section 802(b)(1) or in 10 the United Kingdom has not, because of any 11 concern relating to the safety or effectiveness of 12 the covered product, been rescinded or with- 13 drawn; 14 ‘‘(E) the covered product is not a banned 15 device under section 516; and 16 ‘‘(F) there is a public health or unmet 17 medical need for the covered product in the 18 United States. 19 ‘‘(c) SAFETY AND EFFECTIVENESS.— 20 ‘‘(1) IN GENERAL.—The Secretary— 21 ‘‘(A) may decline to grant reciprocal mar- 22 keting approval under this section with respect 23 to a covered product if the Secretary affirma- 24 tively determines that the covered product— 25 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 154 IS ‘‘(i) is a drug that is not safe and ef- 1 fective; or 2 ‘‘(ii) is a device for which there is no 3 reasonable assurance of safety and effec- 4 tiveness; and 5 ‘‘(B) may condition reciprocal marketing 6 approval under this section on the conduct of 7 specified postmarket studies, which may include 8 such studies pursuant to a risk evaluation and 9 mitigation strategy under section 505–1. 10 ‘‘(2) REPORT TO CONGRESS.—Upon declining 11 to grant reciprocal marketing approval under this 12 section with respect to a covered product, the Sec- 13 retary shall— 14 ‘‘(A) include the denial in a list of such de- 15 nials for each month; and 16 ‘‘(B) not later than the end of the respec- 17 tive month, submit the list to the Committee on 18 Energy and Commerce of the House of Rep- 19 resentatives and the Committee on Health, 20 Education, Labor, and Pensions of the Senate. 21 ‘‘(d) REQUEST.—A request for reciprocal marketing 22 approval shall— 23 ‘‘(1) be in such form, be submitted in such 24 manner, and contain such information as the Sec- 25 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 154 IS retary deems necessary to determine whether the cri- 1 teria listed in subsection (b)(2) are met; and 2 ‘‘(2) include, with respect to each country in- 3 cluded in the list under section 802(b)(1) where the 4 covered product is authorized to be lawfully mar- 5 keted, as described in subsection (b)(2)(A), an 6 English translation of the dossier issued by such 7 country to authorize such marketing. 8 ‘‘(e) TIMING.—The Secretary shall issue an order 9 granting, or declining to grant, reciprocal marketing ap- 10 proval with respect to a covered product not later than 11 30 days after the Secretary’s receipt of a request under 12 subsection (b)(1) for the product. An order issued under 13 this subsection shall take effect subject to Congressional 14 disapproval under subsection (g). 15 ‘‘(f) LABELING; DEVICE CLASSIFICATION.—During 16 the 30-day period described in subsection (e)— 17 ‘‘(1) the Secretary and the sponsor of the cov- 18 ered product shall expeditiously negotiate and final- 19 ize the form and content of the labeling for a cov- 20 ered product for which reciprocal marketing ap- 21 proval is to be granted; and 22 ‘‘(2) in the case of a device for which reciprocal 23 marketing approval is to be granted, the Secretary 24 shall— 25 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 154 IS ‘‘(A) classify the device pursuant to section 1 513; and 2 ‘‘(B) determine whether, absent reciprocal 3 marketing approval, the device would need to be 4 cleared pursuant to section 510(k) or approved 5 pursuant to section 515 to be lawfully marketed 6 under this Act. 7 ‘‘(g) CONGRESSIONAL DISAPPROVAL OF FDA OR- 8 DERS.— 9 ‘‘(1) IN GENERAL.—A decision of the Secretary 10 to decline to grant reciprocal marketing approval 11 under this section shall not take effect if a joint res- 12 olution of disapproval of the decision is enacted. 13 ‘‘(2) PROCEDURE.— 14 ‘‘(A) IN GENERAL.—Subject to subpara- 15 graph (B), the procedures described in sub- 16 sections (b) through (g) of section 802 of title 17 5, United States Code, shall apply to the con- 18 sideration of a joint resolution under this sub- 19 section. 20 ‘‘(B) TERMS.—For purposes of this sub- 21 section— 22 ‘‘(i) the reference to ‘section 23 801(a)(1)’ in section 802(b)(2)(A) of title 24 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 154 IS 5, United States Code, shall be considered 1 to refer to subsection (c)(2); and 2 ‘‘(ii) the reference to ‘section 3 801(a)(1)(A)’ in section 802(e)(2) of title 4 5, United States Code, shall be considered 5 to refer to subsection (c)(2). 6 ‘‘(3) EFFECT OF CONGRESSIONAL DIS- 7 APPROVAL.—Reciprocal marketing approval under 8 this section with respect to the applicable covered 9 product shall take effect upon enactment of a joint 10 resolution of disapproval under this subsection. 11 ‘‘(h) APPLICABILITY OF RELEVANT PROVISIONS.— 12 The provisions of this Act shall apply with respect to a 13 covered product for which reciprocal marketing approval 14 is in effect to the same extent and in the same manner 15 as such provisions apply with respect to a product for 16 which approval or clearance of an application or pre- 17 market notification under section 505(c), 510(k), or 515 18 of this Act or section 351(a) of the Public Health Service 19 Act, as applicable, is in effect. 20 ‘‘(i) FEES FOR REQUEST.—For purposes of imposing 21 fees under chapter VII, a request for reciprocal marketing 22 approval under this section shall be treated as an applica- 23 tion or premarket notification for approval or clearance 24 VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 154 IS under section 505(c), 510(k), or 515 of this Act or section 1 351(a) of the Public Health Service Act, as applicable. 2 ‘‘(j) OUTREACH.—The Secretary shall conduct an 3 outreach campaign to encourage the sponsors of covered 4 products that are potentially eligible for reciprocal mar- 5 keting approval to request such approval. 6 ‘‘(k) COVERED PRODUCT DEFINED.—In this section, 7 the term ‘covered product’ means a drug, biological prod- 8 uct, or device.’’. 9 Æ VerDate Sep 11 2014 20:14 Feb 14, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\S154.IS S154 pamtmann on DSKBC07HB2PROD with BILLS