No more half measures: Senate to add Ebola to priority review program
- RAPS' Alec Gaffney has a big scoop: On November 19, the Senate will consider the Adding Ebola to the FDA Priority Review Voucher Act to expedite drug-development efforts. This voucher allows companies to reduce the 10-month FDA review process by four months.
- Ebola would be the 17th disease to make this list. The legislation was introduced by the outgoing Senate Health, Labor, Education, and Pensions Committee Chairman Sen. Tom Harkin (D-IA) and his imminent replacement, Sen. Lamar Alexander (R-TN).
- In addition to adding Ebola to the list, the Senate will also consider changes to the priority review voucher system, such as reducing the amount of time that companies must give the FDA prior notice about their intention to use a priority review voucher from a full year to just 90 days.
When discussing treatment of a hard-to-treat disease, Hippocrates said: "For extreme diseases, extreme methods of care, as to restriction, are most suitable." That idea was part of the reason that Hippocrates came to be known as the "Father of Medicine."
Since then, medicine has changed dramatically, but the sense of urgency is the same. Sens. Harkin and Alexander have evoked that very compulsion with the proposed changes to the priority review program during the Ebola crisis. Not only will companies developing drugs for designated tropical diseases be able to use a priority review voucher to decrease the review time—they will be able to use it over and over, with only 90 days' notice to the FDA.