House Introduces Bill to Add Ebola to Priority Review Voucher Program

House lawmakers have introduced bipartisan legislation that would give manufacturers of Ebola drugs a voucher that can be used to get priority review for a separate product.

The bill would expand the priority review program for tropical diseases to include all strains of the Ebola virus and the Marburg virus, a related condition. The legislation mirrors a Senate bill that is moving quickly toward approval.

H.R. 5729 was unveiled during a hearing of the House Energy & Commerce Committee’s health subcommittee on the development of new therapies in response to the West Africa outbreak. “There should be an intensive effort to find and approve a treatment, or better yet, a vaccine to prevent Ebola,” said Rep. Marsha Blackburn (R-Tenn.), vice chair of the full committee.

Other lawmakers noted that new incentives are needed to spur development of Ebola treatments since it isn’t a lucrative disease space.

“The need for [a] drug is sporadic and U.S. patient population is almost non-existent and the countries with the most Ebola patients can’t afford to pay high prices,” said Rep. Henry Waxman (D-Calif.), the full committee’s ranking minority member.

The tropical disease voucher program was created in 2007 and expanded in 2012 to include rare pediatric diseases. The voucher is awarded after a drug in the specific disease area is approved, and gives a separate product a review timeline of six months as opposed to the standard 10 months. Vouchers also can be sold to other drugmakers. Knight Therapeutics said it sold a voucher it received for a tropical disease drug to Gilead Sciences for a record $125 million.

The Senate Committee on Health, Education, Labor and Pensions passed companion legislation that now moves to the full Senate.

While the voucher bill has bipartisan support, unity at the House hearing was lacking for President Obama’s $6.18 billion funding request to combat the Ebola outbreak.

The funding will be divvied up between federal agencies represented at the hearing, including the National Institutes of Health, FDA, Centers for Disease Control and Prevention and Biomedical Advanced Research and Development Authority. The FDA is expected to receive a small part of the funding: $25 million to help accelerate review and development of Ebola therapies.

While Democrats on the panel were in favor of the request, some Republicans were skeptical. Rep. Bill Cassidy (R-La.) openly wondered whether the agencies could make do with the funding they have now. — Kellen Owings