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SKAPP Advances Conversation on Strengthening FDA

The Project on Scientific Knowledge and Public Policy (SKAPP) held a panel discussion and workshop in February 2007 to advance the conversation about how the Food and Drug Administration can be strengthened to meet its evolving responsibilities. An Institute of Medicine report calling for reform at the FDA has focused attention on the agency, and upcoming Congressional reauthorization of the Prescription Drug User Fee Act (PDUFA) will keep the FDA in the spotlight.

“Bringing together experts to discuss the future of the FDA yielded a host of insights and ideas for new paths the agency might take,” explains Susan Wood, PhD, who joined SKAPP in 2006 and organized the events. Wood drew national attention to the issue of science being disregarded in the FDA decisions in 2005 when she resigned from her post as the FDA's Director of the Office of Women’s Health and Assistant Commissioner for Women’s Health.

Former FDA Commissioners' Panel Discussion
On February 21st, four former FDA Commissioners shared their views on the challenges and opportunities facing the agency today. Frank E. Young, MD, PhD (Commissioner 1984 – 89), David A. Kessler, MD (Commissioner 1990 -97), and Jane E. Henney, MD (Commissioner 1999 - 2001) appeared at a panel discussion at the George Washington University, and Donald Kennedy, PhD (Commissioner 1977 – 79) joined the panel by phone.

During the panelists’ remarks, several common themes emerged. Interference of politics in FDA’s scientific was one major concern; Kessler specifically raised the Plan B issue as an example of a political move being made under the guise of science, and Henney noted that the agency’s integrity and credibility must be based on a bedrock of scientific evidence – the public, she explained, have confidence in FDA’s decision-making because they believe it’s based on science.

Panelists also noted that recent FDA Commissioners have been serving shorter terms, and that this has made it difficult for strong leadership to exist at the agency. Young suggested that commissioners be given at least a six-year term, and that they have money available to them for ongoing research and training. Several panelists also raised concerns about a lack of funding for the FDA to fulfill its mandates, and Henney and Young suggested moving FDA appropriations out of Congress’s agriculture appropriations process. The need for the executive and legislative branch to work together on strengthening the FDA was a recurring theme throughout the panel discussion.

Panelists also discussed some of the challenges that are emerging as the fields of medicine and food production change. Young suggested that the FDA “is a mirror of the crisis in medicine today.” Kessler predicted that the current model of pharmaceutical development will change because it is not sustainable; the emphasis on blockbuster drugs will have to give way to an era of narrowly targeted drugs, and such a model can’t support today’s Big Pharma.

Other topics discussed during the discussion included current proposed legislation, FDA scientists facing political pressure, independence of federal advisory committee scientists, post-market drug safety, experimental drug access, and direct-to-consumer pharmaceutical advertising. A webcast and transcript of the event are available from Kaisernetwork.org.

“Strengthening the FDA” Workshop
On February 22nd, SKAPP convened a day-long workshop in which more than 40 leading experts and thinkers – many of them former FDA employees – exchanged insights and ideas about how to strengthen the FDA to fulfill its mission. Susan Wood opened the event by reviewing the FDA’s mission statement:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The main topics under discussion included the FDA’s use of science, the impact of its resources, and what the agency might learn from the experience of the National Science Foundation and Social Security Administration, which operate as independent agencies.

Daniel Carpenter, PhD of Harvard University’s Department of Government focused participants’ attention on the effects of PDUFA. He presented two analyses, using two separate methods, that he and his colleagues performed to assess effects of the review time goals adopted under PDUFA. They report:

Using the first set of methods, we find broad evidence that the deadlines have induced a piling of approvals right before the deadline elapses. Using the second set of methods, we find that these "pre-deadline" approvals are subject to substantially different post market experiences than drugs approved either after the deadlines or "very early" in the approval process.

Dr. Carpenter has allowed us to post a draft of his paper, “Deadline Effects in Regulatory Drug Review: A Methodological and Empirical Analysis,” and David W. Feigal, Jr., MD, MPH (a former FDA employee currently with Elan Pharmaceuticals) has allowed us to post the slides from his presentation on the impact of resources on FDA.

Resources:
Kaisernetwork.org webcast of panel discussion
Compilation of quotes from the commissioner panel, organized by topic
Background on current FDA issues
Background documents related to PDUFA
Draft paper from Daniel Carpenter: “Deadline Effects in Regulatory Drug Review: A Methodological and Empirical Analysis”
Presentation by David Feigal regarding resources at the FDA