Endorsements & Opposition
There is general support for adding Zika virus to the eligible list of diseases under the priority review voucher program. The bill moved quickly through the Senate and will likely pass the House.
Support for the voucher program itself, however, is mixed. Some believe that the program isn’t necessary for companies to develop such drugs. Medicines san Frontiers argues that companies should be required to show they conducted the research necessary to obtain approval for the drug. Furthermore, vouchers do not require that companies that develop the drug actually need to sell it. The program also does not require the drugs developed for such tropical diseases to be affordable. It also does not preclude companies from developing a drug with the voucher that is marketed outside the U.S. Additionally, it may discourage innovation because the program incentivizes drug development, not other treatments. Some worry that the accelerated timeline of approval with the voucher by the FDA will cause the FDA to approve drugs without adequate consideration.
Elise Demeter, PhD, Thomas Williams, JD, MBE & Aubrey Incorvaia, MPP