S 2161 — Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019

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things, that their product has been approved in one of the specified countries, the FDA and listed countries have not withdrawn approval because of safety or effectiveness concerns, and there is a public health or unmet medical need for the product.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.

Bill Text

• Introduced Introduced in Senate Current html July 18, 2019

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill introduces provisions for reciprocal marketing approval for certain drugs, biological products, and devices, amending the Federal Food, Drug, and Cosmetic Act.

• 21 U.S.C. 360n

  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.

  This adds a new section for reciprocal marketing approval for certain products.

• 21 U.S.C. 360n

  (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.

  This establishes eligibility criteria for gaining reciprocal marketing approval.

• 21 U.S.C. 360n

  (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.

  This allows the Secretary to assess safety and effectiveness before granting reciprocal marketing approval.

• 21 U.S.C. 360n

  (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.

  This specifies the requirements for submitting a request for reciprocal marketing approval.

• 21 U.S.C. 360n

  (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.

  This sets a timeline for the Secretary's decision on reciprocal marketing approval.

• 21 U.S.C. 360n

  (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.

  This allows Congress to disapprove the Secretary's decision on reciprocal marketing approval.

• 21 U.S.C. 360n

  (k) Covered Product Defined.--In this section, the term `covered product' means a drug, biological product, or device.

  This defines what constitutes a 'covered product' for purposes of this section.

Action History

1. July 18, 2019

   Introduced in Senate

2. July 18, 2019

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

• Ted Cruz · Primary
• Ron Johnson · Cosponsor
• Mike Lee · Cosponsor
• Joni Ernst · Cosponsor

Subjects