250165 Transparency and Accountability at the FDA: Has PDUFA improved scientific integrity?

Tuesday, November 1, 2011: 11:10 AM

Francesca Grifo, PhD , Scientific Integrity Program, Union of Concerned Scientists, Washington, DC
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.

Learning Areas:
Advocacy for health and health education
Public health or related public policy

Learning Objectives:
1) Describe the current state of scientific integrity at , and whether the Food and Drug Administration Amendments Act has effected more accountability and transparency at the agency. 2) Identify the current political landscape and budget realities and their impacts on FDA’s reform initiatives. 3)Assess the FDA Commissioner Margaret Hamburg's conflict of interest guidance and its impact on reducing special interest influence at the agency.

Keywords: Policy/Policy Development, Accountability

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified because I direct a Scientific Integrity Program an have worked closely on PDUFA transparency issues.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.