§360n Priority Review to Encourage Treatments for Tropical Diseases

Summary

The rule creates a special fast review and a tradable voucher to encourage new drugs for tropical diseases. "Priority review" means the FDA must act on a drug application within 6 months. A "priority review voucher" is given to the sponsor of an approved tropical disease product and lets the voucher holder get priority review for one later human drug application. "Tropical disease" covers many named illnesses (for example, tuberculosis, malaria, cholera, dengue, Zika, filovirus diseases, leprosy, and others) and any other infectious disease the Secretary adds that has no big market in wealthy countries and mostly affects poor or marginalized people. A "tropical disease product application" is a human drug or biologic application approved after September 27, 2007 that the FDA finds eligible, includes new clinical trial reports done or sponsored by the applicant (and not previously filed for approval in India, Brazil, Thailand, or certain inspected countries before September 27, 2007), and whose active ingredient has not already been approved in the U.S. When the FDA approves such an application, it must give the sponsor a priority review voucher. The voucher can be transferred or sold any number of times and used once to get priority review. No voucher is allowed for applications submitted before September 27, 2007, and vouchers cannot be issued earlier than one year after September 27, 2007. Anyone planning to use a voucher must tell the FDA at least 90 days before submitting the drug application, and that notice is a binding promise to pay the required fee. The FDA will set a yearly user fee (based on the average cost of priority reviews in the prior year), which is due when the application using the voucher is submitted. Applications are incomplete if the fee is not paid. Fees cannot be waived or refunded, and collected fees go to the FDA’s account only as allowed by Congress.