Reflection and refocus: Former FDA commissioners meet to discuss current agency woes

Washington -- Four former Food and Drug Administration commissioners met recently to discuss how to restore the beleaguered agency's tarnished reputation to its former luster.

The withdrawals of such high profile drugs as the cholesterol-lowering Baycol in 2001 and the pain reliever Vioxx in 2004, coupled with leadership controversies and delays in making an emergency contraceptive available over the counter, have damaged credibility and raised questions about integrity, said the former agency heads.

Donald Kennedy, PhD, commissioner from 1977 to 1979; Frank Young, MD, PhD, 1984 to 1989; David Kessler, MD, 1990 to 1997; and Jane Henney, MD, 1998 to 2001; were at George Washington University School of Public Health and Health Services in Washington, D.C., Feb. 21 for a rare joint discussion on ways to strengthen the agency. The event was moderated by Susan F. Wood, PhD, a GWU research professor who had been director of the FDA's Office of Women's Health until 2005, when she resigned over the delay in approving the over-the-counter contraceptive Plan B.

"We all recognize that we are at an important time for the FDA," Dr. Wood said. Legislation is pending in Congress that would affect funding as well as drug safety and the overall credibility of the agency. "Now is the time for all of us to think broadly about the FDA, because we may not have the opportunity again for several years."

Looking back at the state of the agency he led until 1997, Dr. Kessler, now dean of the School of Medicine at the University of California, San Francisco, thought he and his colleagues had "done a pretty good job." The first HIV drug had been approved and was followed by a dozen more. Average approval time for all new drugs was reduced from 33 months to 12.

Then the withdrawals started, Dr. Kessler said. "Vioxx cost us. An enormous number of people were put at risk."

Dr. Kessler urged a rethinking of the entire pharmaceutical development process. He would like to see a shift away from the blockbuster drugs that have dominated the market for the past decade to a focus on the "right drug, right person, right disease and right dose."

"At least if you are tailoring the drug to the people who need it, then your risk-benefit equation becomes easier," he said.

The handling of Plan B's over-the-counter status also hurt, he said. Some women's groups had accused the agency of unreasonably delaying its decision because of politics. "If you are going to do something for political reasons, OK. But say you are going to do it for political reasons, or you lose credibility."

On the straight and narrow

Maintaining the agency's integrity and credibility is vital to ensuring that it has a strong and bright future, said Dr. Henney, now senior vice president and provost for health affairs at the University of Cincinnati. The agency's decision-making ability has remained credible because it always has been based on science, she said. "In recent days, there has been some question about that."

It is crucial for the agency to return to science when making decisions, Dr. Henney said. The public and the industry depend on the agency's objectivity, especially in approving new drugs, she added.

Dr. Kennedy, president emeritus of Stanford University in Palo Alto, Calif., and editor-in-chief of the journal Science, said one prominent agency need -- that of an effective national system for registering adverse drug reactions -- had remained unaddressed since he took office in 1977. "We don't have anything close to it."

Dr. Kennedy also noted that the public should be made aware that the agency's role is to achieve a balance between the premature introduction of a new therapy and excessive inhibition of innovation. "Unless the public can be educated to recognize this difficult balance, there will be a credibility problem."

As for solutions, all four commissioners agreed that the FDA is underfunded and called on Congress to increase appropriations. "Adequate funding makes a lot else possible," Dr. Kennedy said.

All agreed that a boost in appropriations would be superior to increasing the agency's reliance on the payment of user fees by pharmaceutical companies to fund the review of products being considered for approval.

The user fee program, first authorized in 1992 by the Prescription Drug User Fee Act, is scheduled to be reauthorized this year. User fees now total more than $300 million and fund just more than half of drug reviews. The FDA has proposed that $87 million be added to that total this year.

Dr. Henney, who was at the FDA as deputy commissioner when PDUFA was introduced, said the new law was necessary at the time because the agency was underfunded and faced a backlog of drugs awaiting approval. But she noted that the manufacturers weren't buying approval.

"I worried that there would be a perception that the review process would be too heavily influenced," she said. "I still believe in the integrity of the review process," but she expressed concern that others, including the public, might find the practice questionable. She urged Congress to pay close attention to the balance between user fees and appropriations when considering this year's funding levels.

The former commissioners also endorsed a recommendation made last fall by an Institute of Medicine panel calling for six-year appointments for future commissioners. In the past 30 years, commissioners have served an average of 2.5 years, according to the IOM report, ranging from two months to 6.3 years.

Dr. Young, now CEO of the Cosmos Alliance, an investment company he formed in 2002 to help develop biomedical products, urged that commissioners be recruited in a professional fashion and not named as political appointees.