Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

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. 1. Short title This Act may be cited as the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016 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 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(a); (C) the Secretary has not, because of any concern relating to the safety or effectiveness of the covered product, rescinded or withdrawn any such approval or clearance; (D) the authorization to market the covered product in one or more of the countries included in the list under section 802(b)(1) has not, because of any concern relating to the safety or effectiveness of the covered product, been rescinded or withdrawn; (E) the covered product is not a banned device under section 516; and (F) there is a public health or unmet medical need for the covered product in the United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) (ii) the reference to section 801(a)(1)(A) (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 .

Summary: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to establish 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. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective. The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device. Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process. User fees apply to requests for reciprocal marketing approval. The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.