I 
114TH CONGRESS 
2D SESSION 
H. R. 6241 
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 
SEPTEMBER 28, 2016 
Mr. DESANTIS introduced the following bill; which was referred to the Com-
mittee 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 Act of 2016’’. 
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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); 
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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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retary deems necessary to determine whether the cri-
teria listed in subsection (b)(2) are met; and 
‘‘(2) include, with respect to each country in-
cluded in the list under section 802(b)(1) where the 
covered product is authorized to be lawfully mar-
keted, as described in subsection (b)(2)(A), an 
English translation of the dossier issued by such 
country to authorize such marketing. 
‘‘(e) TIMING.—The Secretary shall issue an order 
granting, or declining to grant, reciprocal marketing ap-
proval with respect to a covered product not later than 
30 days after the Secretary’s receipt of a request under 
subsection (b)(1) for the product. An order issued under 
this subsection shall take effect subject to Congressional 
disapproval under subsection (g). 
‘‘(f) LABELING; DEVICE CLASSIFICATION.—During 
the 30-day period described in subsection (e)— 
‘‘(1) the Secretary and the sponsor of the cov-
ered product shall expeditiously negotiate and final-
ize the form and content of the labeling for a cov-
ered product for which reciprocal marketing ap-
proval is to be granted; and 
‘‘(2) in the case of a device for which reciprocal 
marketing approval is to be granted, the Secretary 
shall— 
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‘‘(A) classify the device pursuant to section 
513; and 
‘‘(B) determine whether, absent reciprocal 
marketing approval, the device would need to be 
cleared pursuant to section 510(k) or approved 
pursuant to section 515 to be lawfully marketed 
under this Act. 
‘‘(g) CONGRESSIONAL DISAPPROVAL OF FDA OR-
DERS.— 
‘‘(1) IN GENERAL.—A decision of the Secretary 
to decline to grant reciprocal marketing approval 
under this section shall not take effect if a joint res-
olution of disapproval of the decision is enacted. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the procedures described in sub-
sections (b) through (g) of section 802 of title 
5, United States Code, shall apply to the con-
sideration of a joint resolution under this sub-
section. 
‘‘(B) TERMS.—For purposes of this sub-
section— 
‘‘(i) 
the 
reference 
to 
‘section 
801(a)(1)’ in section 802(b)(2)(A) of title 
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5, United States Code, shall be considered 
to refer to subsection (c)(2); and 
‘‘(ii) 
the 
reference 
to 
‘section 
801(a)(1)(A)’ in section 802(e)(2) of title 
5, United States Code, shall be considered 
to refer to subsection (c)(2). 
‘‘(3) 
EFFECT
OF
CONGRESSIONAL
DIS-
APPROVAL.—Reciprocal marketing approval under 
this section with respect to the applicable covered 
product shall take effect upon enactment of a joint 
resolution of disapproval under this subsection. 
‘‘(h) APPLICABILITY OF RELEVANT PROVISIONS.— 
The provisions of this Act shall apply with respect to a 
covered product for which reciprocal marketing approval 
is in effect to the same extent and in the same manner 
as such provisions apply with respect to a product for 
which approval or clearance of an application or pre-
market notification under section 505(c), 510(k), or 515 
of this Act or section 351(a) of the Public Health Service 
Act, as applicable, is in effect. 
‘‘(i) FEES FOR REQUEST.—For purposes of imposing 
fees under chapter VII, a request for reciprocal marketing 
approval under this section shall be treated as an applica-
tion or premarket notification for approval or clearance 
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under section 505(c), 510(k), or 515 of this Act or section 
351(a) of the Public Health Service Act, as applicable. 
‘‘(j) OUTREACH.—The Secretary shall conduct an 
outreach campaign to encourage the sponsors of covered 
products that are potentially eligible for reciprocal mar-
keting approval to request such approval. 
‘‘(k) COVERED PRODUCT DEFINED.—In this section, 
the term ‘covered product’ means a drug, biological prod-
uct, or device.’’. 
Æ 
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