Ebola Voucher Law Cuts Wait Time for Redeeming Priority Review
Drugmakers may receive a priority review voucher for a separate product, and redeem it within three months, if they pursue development of Ebola treatments under a new law.
President Obama enacted legislation recently that expands the FDA’s priority review program for tropical diseases to include all strains of the Ebola virus and a related condition called the Marburg virus.
A drugmaker pursuing an Ebola therapy or vaccine can apply to receive a voucher. If the application for a drug or biologic is approved, then the company receives a voucher for a separate product that would get a six month review instead of the normal 10 months.
The law also amends the program to let drugmakers notify the FDA within 90 days of redeeming a voucher. Previously a company had to notify the agency a full year before using one.
Under the law, a drugmaker may continue to sell the voucher to another drugmaker. A voucher recently sold by Knight Therapeutics fetched $125 million from Gilead Sciences.
The law also specifies there is no limit on how many times a voucher can be sold or transferred. Previously there was no reference to the number of times a voucher could be transferred.
Currently there are no treatments or vaccines for Ebola. Congress wanted to spur incentives for drugmakers to pursue treatments in the wake of the West Africa outbreak being described as the worst in history.
To read the law, visit www.fdanews.com/12-18-14-EbolaLaw.pdf. — Robert King