FDA clears new tool for Ebola arsenal
The FDA has exercised its emergency use authority to clear a sixth diagnostic product for combating the Ebola virus, as the US Senate has advanced legislation to include Ebola as a tropical disease eligible for a voucher program incenting development of treatments for the disease. The agency has cleared the RealStar Ebola virus RT-PCR Kit 1.0 manufactured by altona Diagnostic GmbH of Hamburg, Germany. The device has the advantage of being able to detect all Ebola virus species through analysis of in vitro samples of plasma from persons thought to be infected, RAPS reports.
Aimed at speeding development of Ebola treatments, the bipartisan legislation from the Senate's Health Education Labor and Pensions (HELP) committee would amend by statute the Tropical Disease Priority Review Voucher program to include the Ebola virus as an eligible disease. In the system, companies with successfully developed drugs are granted transferable vouchers which entitle a shortened six-month priority review.
The bill also makes several notable changes to the voucher system. Companies could give FDA just 90 days notice prior to using a voucher instead of the full year's notice now required; tropical vouchers which now cannot be sold more than once will be sellable an unlimited number of times; and FDA going forward would be able to amend the list of eligible diseases under the program via orders rather than through regulation.