U.S. Lawmakers To Add Ebola Drugs To Priority Review Voucher Program

By Cyndi Root

Lawmakers in the U.S. seek to add the Ebola virus to the priority review voucher program that extends benefits to pharmaceutical companies for developing treatments for certain diseases. The voucher program was established in 2007 by an Act of Congress and two senators intend to introduce a bill adding Ebola to the list. Currently, many tropical diseases urgently need treatments. The voucher program rewards companies that submit a treatment for review by extending the right to a faster review of the companies’ next drug.

The voucher program extends a priority review to the company that submits a drug for one of the diseases or conditions specified in the program. This review has a PDUFA goal date of 6 months in contrast to the standard 10 months. The Food and Drug Administration (FDA) still expects the sponsor to submit fees for the human drug application, and there are a number of conditions to redeem the voucher.

Drug makers seeking to qualify for the voucher program must submit an application for one of the listed tropical disease, and the drug or biological candidate must not have any active ingredient that has been approved before. Currently 16 diseases or conditions occupy the list, and the rules state that a drug candidate may be for “Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.”

Ebola Voucher Bill

While the FDA states in its guidance that treatments for other diseases than those listed are acceptable under certain conditions, Senators Lamar Alexander (R-Tenn) and Tom Harkin (D-Iowa) are introducing the bill to specifically include the Ebola virus in the program. Senator Alexander said in a statement, “This bill will help fight Ebola with a tool that encourages the development of necessary but unprofitable drugs — offering a reward for drug makers who invest the time and resources to develop drugs to treat, and hopefully cure, Ebola.”

Consumer advocacy groups are weighing in before the Senators submit the Harkin-Alexander bill, asking that the bill reflect some oversight on pharmaceutical companies, including the expected cost of the treatment and financial details if the company sells the voucher to another entity.