Transparency and Accountability at the FDA: Has PDUFA improved scientific integrity?

Transparency and accountability are central to ensuring scientific integrity in the decision-making process at the Food and Drug Administration (FDA). Next year, Congress will reauthorize the Prescription Drug User Fee Act (PDUFA), a law which gives the FDA the authority to negotiate user fees with the pharmaceutical industry to pay for certain aspects of the agency's drug approval process. This framework generates inherent conflicts of interest. However, PDUFA reauthorization and enactment have proven to be vehicles for positive reforms at the FDA. The Food and Drug Administration Amendments Act (FDAAA), approved as part of the 2007 PDUFA reauthorization, enlarged the participation of stakeholders in the PDUFA process and increased its transparency. FDAAA also directed the FDA to reduce the number of conflicted experts on its advisory panels, and it instituted new rules to ensure that FDA scientists would be able to more easily publish their research in peer-reviewed journals. FDAAA also required more disclosure of the science behind drug approvals and the advisory discussions; however not all of these reforms have been enacted. More recently, the FDA, under Commissioner Margaret Hamburg, issued a guidance document on conflict of interest that directs agency staff to make greater efforts to operate as free of special-interest influence as possible. PDUFA reauthorization provides another opportunity to increase transparency and strengthen scientific integrity in FDA drug approvals, but it will require concerted outside attention to assure that appropriate changes are made, and ultimately enacted. Where these efforts stand, and what the future of PDUFA holds for scientific integrity and public health will be explored and discussed, as well as the role the public health community can have in ensuring positive reforms. Specifically, the impact of the new conflict of interest guidance, and the current political landscape and budget realities will be examined in the context of their impacts on the FDA's reform initiatives.