I 
116TH CONGRESS 
2D SESSION 
H. R. 6260 
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 HOUSE OF REPRESENTATIVES 
MARCH 12, 2020 
Mr. ROY introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Rules, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Reciprocity Ensures 
Streamlined 
Use 
of 
Lifesaving 
Treatments 
for 
Coronavirus Patients Act of 2020’’. 
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SEC. 2. RECIPROCAL MARKETING APPROVAL FOR CERTAIN 
DRUGS, BIOLOGICAL PRODUCTS, AND DE-
VICES. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 524A of such Act (21 U.S.C. 
360n–1) the following: 
‘‘SEC. 524B. RECIPROCAL MARKETING APPROVAL. 
‘‘(a) IN GENERAL.—A covered product with recip-
rocal marketing approval in effect under this section is 
deemed to be subject to an application or premarket notifi-
cation for which an approval or clearance is in effect under 
section 505(c), 510(k), or 515 of this Act or section 
351(a) of the Public Health Service Act, as applicable. 
‘‘(b) ELIGIBILITY.—The Secretary shall, with respect 
to a covered product, grant reciprocal marketing approval 
if— 
‘‘(1) the sponsor of the covered product submits 
a request for reciprocal marketing approval; and 
‘‘(2) the request demonstrates to the Sec-
retary’s satisfaction that— 
‘‘(A) the covered product is authorized to 
be lawfully marketed in one or more of the 
countries included in the list under section 
802(b)(1) for the treatment or prevention the 
coronavirus or another disease of epidemic po-
tential; 
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‘‘(B) absent reciprocal marketing approval, 
the covered product is not approved or cleared 
for marketing, as described in subsection (a); 
‘‘(C) the Secretary has not, because of any 
concern relating to the safety or effectiveness of 
the covered product, rescinded or withdrawn 
any such approval or clearance; 
‘‘(D) the authorization to market the cov-
ered product in one or more of the countries in-
cluded in the list under section 802(b)(1) has 
not, because of any concern relating to the safe-
ty or effectiveness of the covered product, been 
rescinded or withdrawn; 
‘‘(E) the covered product is not a banned 
device under section 516; and 
‘‘(F) there is a public health or unmet 
medical need for the covered product in the 
United States. 
‘‘(c) SAFETY AND EFFECTIVENESS.— 
‘‘(1) IN GENERAL.—The Secretary— 
‘‘(A) may decline to grant reciprocal mar-
keting approval under this section with respect 
to a covered product if the Secretary affirma-
tively determines that the covered product— 
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‘‘(i) is a drug that is not safe and ef-
fective; or 
‘‘(ii) is a device for which there is no 
reasonable assurance of safety and effec-
tiveness; and 
‘‘(B) may condition reciprocal marketing 
approval under this section on the conduct of 
specified postmarket studies, which may include 
such studies pursuant to a risk evaluation and 
mitigation strategy under section 505–1. 
‘‘(2) REPORT TO CONGRESS.—Upon declining 
to grant reciprocal marketing approval under this 
section with respect to a covered product, the Sec-
retary shall— 
‘‘(A) include the denial in a list of such de-
nials for each month; and 
‘‘(B) not later than the end of the respec-
tive month, submit the list to the Committee on 
Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate. 
‘‘(d) REQUEST.—A request for reciprocal marketing 
approval shall— 
‘‘(1) be in such form, be submitted in such 
manner, and contain such information as the Sec-
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