S 3220 — A bill to expand the tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis.

(a) Definitions In this section: (1) Priority review The term “priority review”, with respect to a human drug application as defined in section 379g(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007. (2) Priority review voucher The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 355(b)(1) of this title or section 262 of title 42 after the date of approval of the tropical disease product application. (3) Tropical disease The term “tropical disease” means any of the following: (A) Tuberculosis. (B) Malaria. (C) Blinding trachoma. (D) Buruli Ulcer. (E) Cholera. (F) Dengue/dengue haemorrhagic fever. (G) Dracunculiasis (guinea-worm disease). (H) Fascioliasis. (I) Human African trypanosomiasis. (J) Leishmaniasis. (K) Leprosy. (L) Lymphatic filariasis. (M) Onchocerciasis. (N) Schistosomiasis. (O) Soil transmitted helmithiasis. (P) Yaws. (Q) Filovirus Diseases. (R) Zika Virus Disease. (S) Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary. (4) Tropical disease product application The term “tropical disease product application” means an application that— (A) is a human drug application as defined in section 379g(1) of this title— (i) for prevention or treatment of a tropical disease; (ii) the Secretary deems eligible for priority review; (iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and (iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.1 (B) is approved after September 27, 2007, by the Secretary for use in the prevention, detection, or treatment of a tropical disease; and (C) is for— (i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or (ii) a biological product, no active ingredient of which has been approved in any other application under section 262 of title 42. (b) Priority review voucher (1) In general The Secretary shall award a priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such tropical disease product application. (2) Transferability The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 355(b)(1) of this title or section 262 of title 42 will be submitted after the date of the approval of the tropical disease product application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. (3) Limitation (A) No award for prior approved application A sponsor of a tropical disease product may not receive a priority review voucher under this section if the tropical disease product applicatio...