How Congress is failing on Zika
Earlier this year, Congress hastily passed a bill adding Zika to the Food and Drug Administration priority review voucher program. The bill was introduced by Sen. Al Franken of Minnesota in February, cleared the Senate in March and passed a month later in the House.
The main goal of the voucher program is to spur development of new drugs for neglected diseases. Pharmaceutical companies seeking approval of a Zika vaccine or therapy may now receive a transferable voucher that shortens FDA review period of a second, unrelated drug by about four months. Having a second drug enter the market faster could generate financial gains more quickly and is designed to create an incentive for pharmaceutical companies to allocate more resources to otherwise underfunded diseases like Zika.
Priority review vouchers initially covered neglected tropical diseases like Chagas, or sleeping sickness. Later, they were expanded to include rare pediatric diseases. The program was an attempt to encourage costly research and development in areas with markets that are too small for companies to recover the costs associated with generating innovative drugs and therapies.
The voucher is a prize companies are free to use as they wish. Many use the voucher to bolster in-house drugs. Alternatively, they can sell the voucher to other companies, who may then apply for priority review of any drug. Abbvie set a record last year by paying $350 million for one of these vouchers.
At first blush, the mechanism is clever: The pharmaceutical industry self-funds R&D while stimulating innovation in traditionally neglected areas. The problem is that money generated under Zika priority review is unlikely to ever be spent on Zika R&D – or on any other type of neglected disease.
As rational economic agents, what are pharmaceutical companies likely to do after obtaining a voucher? Scholars predict they will invest it in one of their blockbuster drugs, destined for the larger and more reliable markets of money-making diseases like cholesterol, acid reflux or asthma. Studies also show that pharmaceutical companies have used the voucher program to bring drugs developed outside the United States to the FDA for regulatory approval. They then pocket the profits derived from the voucher.
Not only is the priority review program misaligned with the goals of promoting R&D for neglected diseases, but the vouchers also consume FDA’s internal resources and force the agency to reshuffle its priorities. A month before Congress made Zika eligible for priority review, the FDA suggested ending the program.
The task of increasing R&D and funding for neglected diseases was already a complicated one. Governmental agencies like the FDA don’t necessarily want to play a role in promoting these goals, as programs like the priority review vouchers take resources away from their general mandate.
One thing the Zika crisis has made clear is that solving emerging disease outbreaks increasingly involves navigating treacherous political waters. Congress’ lack of understanding of the real scope of voucher program compromises efforts to find new ways of encouraging R&D in neglected diseases like Zika. Its inaction when it comes to extending funding for a major outbreak may endanger the health of thousands of Americans.
Ana Santos Rutschman is Jaharis Faculty Fellow in Health Law and Intellectual Property, DePaul University. This article is published courtesy of The Conversation (under Creative Commons-Attribution / No derivative).
