§360n Priority Review to Encourage Treatments for Tropical Diseases

Summary

Gives a prize called a "priority review voucher" to a company when the FDA approves a new drug or biologic for a listed tropical disease. A priority review means the FDA will act on a drug application within 6 months after it gets the application. The law names many tropical diseases (for example, tuberculosis, malaria, dengue, Zika, filovirus diseases, leprosy, schistosomiasis) and also allows the FDA to add other infectious diseases that mainly hurt poor people and lack a big market in wealthy countries. A qualifying tropical disease product application must be for prevention or treatment, be approved after September 27, 2007, include new clinical trials run or sponsored by the applicant, include a statement that those trial reports were not submitted for approval in India, Brazil, Thailand, or certain inspection-agreement countries before September 27, 2007, and must contain an active moiety or ingredient not previously approved. When FDA approves a qualifying tropical disease product, it gives its sponsor one priority review voucher. The voucher can be sold or transferred any number of times before it is used. A sponsor cannot get a voucher for applications submitted before September 27, 2007, and the FDA will not issue any vouchers earlier than one year after that date. If a company plans to use a voucher, it must tell the FDA at least 90 days before sending in the drug application and agree to pay a special user fee. The FDA sets that fee each year based on the average cost of priority reviews, the fee is due when the voucher-use application is filed, there are no waivers or refunds, and the fees go into FDA’s account only as allowed by Congress.