[Congressional Record Volume 163, Number 127 (Thursday, July 27, 2017)]
[Senate]
[Pages S4451-S4452]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 417. Mr. CRUZ submitted an amendment intended to be proposed to
amendment SA 267 proposed by Mr. McConnell to the bill H.R. 1628, to
provide for reconciliation pursuant to title II of the concurrent
resolution on the budget for fiscal year 2017; which was ordered to lie
on the table; as follows:
At the appropriate place, insert the following:
SEC. __. RECIPROCAL MARKETING APPROVAL FOR CERTAIN DRUGS,
BIOLOGICAL PRODUCTS, AND DEVICES.
The Federal Food, Drug, and Cosmetic Act is amended 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 reciprocal
marketing approval in effect under this section is deemed to
be subject to an application or premarket notification 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 Secretary'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);
``(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product, rescinded or withdrawn any such approval or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 covered product in
one or more of the countries included in the list under
section 802(b)(1) has not, because of any concern relating to
the safety 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rescinded or withdrawn;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 marketing approval
under this section with respect to a covered product if the
Secretary affirmatively determines that the covered product--
``(i) is a drug that is not safe and effective; or
``(ii) is a device for which there is no reasonable
assurance of safety and effectiveness; 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 Secretary shall--
``(A) include the denial in a list of such denials for each
month; and
``(B) not later than the end of the respective month,
submit the list to the Committee on Energy and Commerce of
the House of Representatives 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 Secretary deems necessary to
determine whether the criteria listed in subsection (b)(2)
are met; and
``(2) include, with respect to each country included in the
list under section 802(b)(1) where the covered product is
authorized to be lawfully marketed, 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 approval 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 covered product
shall expeditiously negotiate and finalize the form and
content of the labeling for a covered product for which
reciprocal marketing approval is to be granted; and
``(2) in the case of a device for which reciprocal
marketing approval is to be granted, the Secretary shall--
``(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 Orders.--
``(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 resolution of disapproval of
the decision is enacted.
``(2) Procedure.--
``(A) In general.--Subject to subparagraph (B), the
procedures described in subsections (b) through (g) of
section 802 of title 5, United States Code, shall apply to
the consideration of a joint resolution under this
subsection.
``(B) Terms.--For purposes of this subsection--
``(i) the reference to `section 801(a)(1)' in section
802(b)(2)(A) of title 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 disapproval.--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 premarket 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
application or premarket notification for approval or
clearance under section 505(c), 510(k), or 515 of
[[Page S4452]]
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 marketing approval to
request such approval.
``(k) Covered Product Defined.--In this section, the term
`covered product' means a drug, biological product, or
device.''.
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