§360n Priority review to encourage treatments for tropical diseases

Summary

When the FDA approves a qualifying drug for a tropical disease, the drug’s sponsor gets a priority review voucher. Priority review means the FDA must act on the later drug application within 6 months. The voucher can be used for one future human drug or biological-product application (under 21 U.S.C. 355(b)(1) or 42 U.S.C. 262) filed after the tropical product is approved. The voucher can be sold or transferred any number of times. It only applies to tropical disease drugs approved after September 27, 2007, and vouchers are not issued any earlier than the date that is 1 year after September 27, 2007. Tropical diseases listed include tuberculosis, malaria, cholera, dengue, Zika, filovirus diseases, and several others, plus any other infectious disease the Secretary names that has little market in developed countries and mainly affects poor or marginalized people. A qualifying tropical disease application must be for prevention or treatment, be eligible for priority review, include new clinical trial reports done or sponsored by the applicant (not just bioavailability studies), include a sworn statement that those reports were not submitted for approval in India, Brazil, Thailand, or any member of the Pharmaceutical Inspection Convention or Cooperation Scheme before September 27, 2007, and must be for a drug or biologic whose active moiety/ingredient has not been approved before. A sponsor who wants to use a voucher must tell the FDA at least 90 days before they submit the later application, and that notice is a binding promise to pay the special priority-review fee. The FDA will set that fee each fiscal year based on the prior year’s average cost to do priority reviews and must set it before the fiscal year (the rule starts after September 30, 2007). The fee is due when the application is submitted. If the fee and all other FDA user fees are not paid, the application is incomplete. The FDA cannot waive or refund these fees. Fees collected go to the FDA’s appropriation account as offsetting collections and may only be collected to the extent allowed by appropriations laws.