Posted 18 December 2014
By Alexander Gaffney, RAC
President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars.
The law, Adding Ebola to the FDA Priority Review Voucher Program Act, was signed into law by Obama on 16 December 2013.
The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a program created in 2007 to spur the development of new treatments for tropical diseases—diseases which disproportionately affect developing countries.
The program's centerpiece is a voucher that allows a company to receive "priority review" status for any drug, allowing FDA to review it for approval in just six months instead of the usual 10. The voucher can also be sold.
For a complete explanation of the Ebola voucher reform bill, please see our explainer article here.
As written, the law makes several notable changes to the program.
First, it permits a tropical PRV to be redeemed by its intended user in just 90 days. Previously, a company needed to give FDA a full 365 days' notice prior to sending the agency an application.
Second, it adds Ebola to the list of products eligible to receive a PRV.
Third, it permits a voucher to be sold—"transferred"—an unlimited number of times. Previously, a voucher could only be sold once, which made it potentially risky to purchase.
It remains unclear if FDA will retroactively apply the new voucher standards to existing tropical PRVs, such as one purchased by Gilead in November 2014 for $125 million. If the agency does, Gilead's voucher could go from being redeemable in 365 days to being redeemable in just 90 days, thereby allowing it to get its product to market even faster.
Obama Signing Statement