II 

116TH CONGRESS 

1ST SESSION S. 2161 

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 purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2019 

Mr. CRUZ (for himself, Mr. JOHNSON, and Mr. LEE) introduced the following 

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 authorized to be lawfully marketed abroad, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Reciprocity Ensures 

5 Streamlined Use of Lifesaving Treatments Act of 2019’’. 


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1 SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN 

2 DRUGS, BIOLOGICAL PRODUCTS, AND DE3 VICES. 

4 The Federal Food, Drug, and Cosmetic Act is amend5 ed by inserting after section 524A of such Act (21 U.S.C. 

6 360n–1) the following: 

7 ‘‘SEC. 524B. RECIPROCAL MARKETING APPROVAL. 

8 ‘‘(a) IN GENERAL.—A covered product with recip9 rocal marketing approval in effect under this section is 

10 deemed to be subject to an application or premarket notifi11 cation for which an approval or clearance is in effect under 

12 section 505(c), 510(k), or 515 of this Act or section 

13 351(a) of the Public Health Service Act, as applicable. 

14 ‘‘(b) ELIGIBILITY.—The Secretary shall, with respect 

15 to a covered product, grant reciprocal marketing approval 

16 if— 

17 ‘‘(1) the sponsor of the covered product submits 

18 a request for reciprocal marketing approval; and 

19 ‘‘(2) the request demonstrates to the Sec20 retary’s satisfaction that— 

21 ‘‘(A) the covered product is authorized to 

22 be lawfully marketed in one or more of the 

23 countries included in the list under section 

24 802(b)(1); 


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1 ‘‘(B) absent reciprocal marketing approval, 

2 the covered product is not approved or cleared 

3 for marketing, as described in subsection (a); 

4 ‘‘(C) the Secretary has not, because of any 

5 concern relating to the safety or effectiveness of 

6 the covered product, rescinded or withdrawn 

7 any such approval or clearance; 

8 ‘‘(D) the authorization to market the cov9 ered product in one or more of the countries in10 cluded in the list under section 802(b)(1) has 

11 not, because of any concern relating to the safe12 ty or effectiveness of the covered product, been 

13 rescinded or withdrawn; 

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 mar22 keting approval under this section with respect 

23 to a covered product if the Secretary affirma24 tively determines that the covered product— 


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1 ‘‘(i) is a drug that is not safe and ef2 fective; or 

3 ‘‘(ii) is a device for which there is no 

4 reasonable assurance of safety and effec5 tiveness; and 

6 ‘‘(B) may condition reciprocal marketing 

7 approval under this section on the conduct of 

8 specified postmarket studies, which may include 

9 such studies pursuant to a risk evaluation and 

10 mitigation strategy under section 505–1. 

11 ‘‘(2) REPORT TO CONGRESS.—Upon declining 

12 to grant reciprocal marketing approval under this 

13 section with respect to a covered product, the Sec14 retary shall— 

15 ‘‘(A) include the denial in a list of such de16 nials for each month; and 

17 ‘‘(B) not later than the end of the respec18 tive month, submit the list to the Committee on 

19 Energy and Commerce of the House of Rep20 resentatives and the Committee on Health, 

21 Education, Labor, and Pensions of the Senate. 

22 ‘‘(d) REQUEST.—A request for reciprocal marketing 

23 approval shall— 

24 ‘‘(1) be in such form, be submitted in such 

25 manner, and contain such information as the SecVerDate Sep 11 2014 23:34 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2161.IS S2161

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1 retary deems necessary to determine whether the cri2 teria listed in subsection (b)(2) are met; and 

3 ‘‘(2) include, with respect to each country in4 cluded in the list under section 802(b)(1) where the 

5 covered product is authorized to be lawfully mar6 keted, as described in subsection (b)(2)(A), an 

7 English translation of the dossier issued by such 

8 country to authorize such marketing. 

9 ‘‘(e) TIMING.—The Secretary shall issue an order 

10 granting, or declining to grant, reciprocal marketing ap11 proval with respect to a covered product not later than 

12 30 days after the Secretary’s receipt of a request under 

13 subsection (b)(1) for the product. An order issued under 

14 this subsection shall take effect subject to Congressional 

15 disapproval under subsection (g). 

16 ‘‘(f) LABELING; DEVICE CLASSIFICATION.—During 

17 the 30-day period described in subsection (e)— 

18 ‘‘(1) the Secretary and the sponsor of the cov19 ered product shall expeditiously negotiate and final20 ize the form and content of the labeling for a cov21 ered product for which reciprocal marketing ap22 proval is to be granted; and 

23 ‘‘(2) in the case of a device for which reciprocal 

24 marketing approval is to be granted, the Secretary 

25 shall— 


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1 ‘‘(A) classify the device pursuant to section 

2 513; and 

3 ‘‘(B) determine whether, absent reciprocal 

4 marketing approval, the device would need to be 

5 cleared pursuant to section 510(k) or approved 

6 pursuant to section 515 to be lawfully marketed 

7 under this Act. 

8 ‘‘(g) CONGRESSIONAL DISAPPROVAL OF FDA OR9 DERS.— 

10 ‘‘(1) IN GENERAL.—A decision of the Secretary 

11 to decline to grant reciprocal marketing approval 

12 under this section shall not take effect if a joint res13 olution of disapproval of the decision is enacted. 

14 ‘‘(2) PROCEDURE.— 

15 ‘‘(A) IN GENERAL.—Subject to subpara16 graph (B), the procedures described in sub17 sections (b) through (g) of section 802 of title 

18 5, United States Code, shall apply to the con19 sideration of a joint resolution under this sub20 section. 

21 ‘‘(B) TERMS.—For purposes of this sub22 section— 

23 ‘‘(i) the reference to ‘section 

24 801(a)(1)’ in section 802(b)(2)(A) of title 


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1 5, United States Code, shall be considered 

2 to refer to subsection (c)(2); and 

3 ‘‘(ii) the reference to ‘section 

4 801(a)(1)(A)’ in section 802(e)(2) of title 

5 5, United States Code, shall be considered 

6 to refer to subsection (c)(2). 

7 ‘‘(3) EFFECT OF CONGRESSIONAL DIS8 APPROVAL.—Reciprocal marketing approval under 

9 this section with respect to the applicable covered 

10 product shall take effect upon enactment of a joint 

11 resolution of disapproval under this subsection. 

12 ‘‘(h) APPLICABILITY OF RELEVANT PROVISIONS.— 

13 The provisions of this Act shall apply with respect to a 

14 covered product for which reciprocal marketing approval 

15 is in effect to the same extent and in the same manner 

16 as such provisions apply with respect to a product for 

17 which approval or clearance of an application or pre18 market notification under section 505(c), 510(k), or 515 

19 of this Act or section 351(a) of the Public Health Service 

20 Act, as applicable, is in effect. 

21 ‘‘(i) FEES FOR REQUEST.—For purposes of imposing 

22 fees under chapter VII, a request for reciprocal marketing 

23 approval under this section shall be treated as an applica24 tion or premarket notification for approval or clearance 


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1 under section 505(c), 510(k), or 515 of this Act or section 

2 351(a) of the Public Health Service Act, as applicable. 

3 ‘‘(j) OUTREACH.—The Secretary shall conduct an 

4 outreach campaign to encourage the sponsors of covered 

5 products that are potentially eligible for reciprocal mar6 keting approval to request such approval. 

7 ‘‘(k) COVERED PRODUCT DEFINED.—In this section, 

8 the term ‘covered product’ means a drug, biological prod9 uct, or device.’’. 

Æ 


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