HR5729 and S2917 would make changes to an incentive programme already run by the US Food and Drug Administration (FDA) that awards priority review vouchers to companies which make drugs for tropical diseases.
The proposed rules would open up the qualifying tropical diseases to include Filoviruses, a family of viruses that includes Ebola and Marburg.
The vouchers can be used by makers of qualifying treatments to speed up future new drug applications (NDAs) for separate products, paring the regulator’s review time down from the usual ten months to six.
To redeem the voucher, a sponsor must pay an extra fee set by FDA each year to cover the agency’s cost for accelerated review.
Sold for $125m
The bills would also authorise the FDA to expand the list of qualifying diseases even further through an administrative order, rather than through a formal rule. The legislation would remove a limit on the number of times vouchers can be sold or transferred and would reduce the period required between notice by a sponsor and use of a voucher from one year to 90 days.
The House of Representatives bill has broad support from both Democrats and Republicans, led by Representatives Gene Green (D-TX) and Marsha Blackburn (R-TN).
Green said, “In 2007, Congress took action to break down economic barriers for developing treatments and vaccines against tropical diseases by establishing the tropical disease priority review voucher programme. Now it’s time for Congress to act again, and respond to the Ebola outbreak by making therapies and vaccines to treat the deadly virus eligible for the programme.”
Vouchers can be transferred between pharma companies. In the first known example, Knight Therapeutics announced last week it had sold the priority review voucher it received in March for Impavido, a parasite medicine, to Gilead Sciences for $125m.