Regulatory Focus™ > News Articles > US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

Posted 20 November 2014 | By Alexander Gaffney, RAC 

US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

Bill Background

The legislation, the Adding Ebola to the FDA Priority Review Voucher Program Act, would make three notable changes to the neglected tropical disease PRV program. First, it would shorten the amount of time necessary for it to be redeemed from its current 365 days to just 90 days. Second, it would permit the voucher to be sold an unlimited number of times instead of its current limit of just one sale. And third, the bill would explicitly add the category of Filovirus—a category which includes the Ebola virus as well as the Marburg and Lloviu virus—to the PRV program, making products approved to treat them eligible for the voucher.

While FDA currently has the authority to add diseases to the list of eligible diseases under the PRV program, it can only do so through regulation—a long process which would likely take longer to accomplish than the passage of the bill.

For more information about the PRV program and its history, please see Focus' story from 12 November 2014: "US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola."

Senate Surges Ahead, With House Close Behind

On 19 November 2014, the Senate Health, Education, Labor and Pensions (HELP) Committee—the Senate committee charged with FDA oversight—announced it had approved the bill. It will now go before the entire Senate for a vote, where it is expected to pass. The bill currently has 45 co-sponsors—nearly half the Senate.

Separately, Reps. Gene Green (D-TX) and Marsha Blackburn (R-TN) also introduced an identical companion bill in the House on 18 November 2014. The bill has already attracted three additional bi-partisan co-sponsors, and has been referred to the House Energy and Commerce Committee for mark-up and consideration.


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