US senators are working to introduce a bill to encourage pharma and biotech companies to develop new treatments and vaccines against Ebola. Specifically, the bill would add Ebola to FDA’s priority review voucher program, first introduced in 2007. The program incentivizes the development of medicines for neglected tropical diseases. As well as providing faster review of the qualifying medicine, the FDA also awards a priority review voucher to the developer, which can be used for any other product, whether qualifying or not.
The vouchers can also be sold, but only once, and overall they are considered less valuable than vouchers offered through other FDA programs, such as the FDA’s rare pediatric disease voucher program (one of which was sold by BioMarin for $67.5 million earlier this year). Vouchers obtained through the neglected tropical diseases program can only be redeemed by giving the FDA 365-days’ notice and have rarely been used by companies. Therefore, critics are dubious as to whether adding Ebola to the list will have a positive – or any – impact (1). Especially as it could be months before any Ebola drug is eligible for the scheme since companies must first receive full approval for their investigational new drug application. Sixteen diseases currently qualify for the program, but Ebola is not one of them since previous outbreaks have been sporadic and the death toll lower than diseases like cholera, malaria and tuberculosis.
Meanwhile, Europe is also trying to spur development; the Innovative Medicines Initiative recently issued a €280-million call for projects to boost European research into Ebola. The funding will cover “urgent action” to address the current epidemic and a long-term strategy for managing future outbreaks.
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References
- A. Gaffney, “Senators Call for Expansion of FDA Program to Help Fight Ebola”, 28 October 2014, http://www.raps.org
