Title: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
Policy area: Health

Summary:
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019
This bill establishes a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country and there is an unmet need.
Specifically, the bill requires the product's sponsor to demonstrate, among other things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.
The FDA may only decline approval if the FDA determines that the product is not safe or effective. The FDA must make such a determination not later than 30 days after receiving a request.
Congress may pass a joint resolution to grant reciprocal marketing approval of a product that the FDA declines to approve through the reciprocal process.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2161 Introduced in Senate (IS)]

<DOC>






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.

    Be it enacted by the Senate and House of Representatives 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 2019''.

SEC. 2. 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 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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