Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

Posted 04 December 2014 | By Alexander GaffneyRAC

Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

The US House has quickly passed legislation making changes to the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus.

S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act, passed the US House of Representatives by unanimous consent on 3 December 2013, just one day after the same bill was passed by the US Senate.

As in the Senate, the legislation passed the House "without objection."

The bill adds the Ebola virus to a list of diseases allowing drug manufacturers to become eligible to receive a special incentive if they get an Ebola treatment approved by FDA. The incentive, a special priority review voucher, would allow a company to have any one of its drugs received by FDA in just 6 months instead of the usual 10. The legislation also allows vouchers to be redeemed more quickly (in 90 days instead of 365) and to be sold an unlimited number of times instead of just once.

For a complete explanation of the Ebola voucher reform bill, please see our explainer article here,

House legislators said the bill would "help encourage more investment and innovation for the development of treatments for these diseases." Senate legislators made similar remarks the day prior, saying the legislation was a "strong step" that might "one day help lead to a cure" for the Ebola virus.

The bill now goes to President Barack Obama, who is expected to sign it.

 

House Statement

Bill Tracker for S.2917


Categories: Regulatory News

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