Medical Device Daily Washington Editor

WASHINGTON — The May 1 meeting of the House Government Oversight and Reform Committee featured presentations by former commissioners of the FDA as well as the current incumbent, all enumerating the well-publicized problems encountered by the agency. And one former FDA chief said that Congress's monitoring and funding of the agency — because dysfunctional — is also one of those problems.

Committee chairman Henry Waxman (D-California) opened the session by saying that "some believe in having the smallest government possible and live by the old joke that the scariest words in the English language are, 'I'm from the government and I'm here to help.'"

Waxman said that government "can be a tremendous instrument of good" and that FDA "has had a remarkable record of accomplishment" in this regard. However, the troubles involving the drug Vioxx, tainted spinach and toxic pet food "reveal an alarming number of cracks" in the agency's function.

"The agency's history is full of success stories," including the pulling of thalidomide in the 1960s, and the effort required to speed aids drugs to market, Waxman said, adding, however, that "the agency, in my opinion, is vastly under-funded."

Still, "for all its challenges, FDA remains one of our nation's greatest assets," Waxman said.

Thomas Davis (R-Virginia), the ranking minority member, said that "in recent years, the agency has stumbled through some high-profile missteps," and that any thumbs-up to a product by the agency strikes citizens as a "good housekeeping seal of approval" — and thus the assumption that any approved products "can be used without worry or risk."

"We need to be sure that confidence is not misplaced, or grounded only on the legend of an infallible FDA or the myth of risk-free products," Davis said.

He said that the committee's review of FDA problems is no novelty.

"This committee has looked at some of these questions before," he said, noting several situations that the committee examined under GOP leadership, including the investigation into the flu vaccine shortage that "resulted in more frequent on-site FDA inspections.

"With regard to this range of issues, it can't be said that Republicans did no oversight for six years."

Donald Kennedy, former FDA commissioner from 1977 to 1979, and now editor-in-chief of Science magazine, said that FDA has operated under a budget crunch, and he estimated that proper appropriation for the agency in 2008 would be roughly $1.9 billion, not $1.56 billion.

Kennedy said user fees are no substitute for appropriated funds for two reasons, the first being a public perception that user fees unduly influence the agency's conduct.

"I am confident that PDUFA [the Prescription Drug User fee Act] and the agency have that under control, but the perception may be more general than we hope," he said.

Secondly, he said that drug user fees help to pay for reviewers' salaries "but not the external costs they bring to the agency management."

The listing of clinical trial data "appears to be an appropriate response" to the drug safety report released last September by the Institute of Medicine (Washington), he said, but "although the trials are listed, there is no information about the institutions, the investigators or the problems." Consequently, "to call them publicly available in any real sense is silly."

Kennedy reminded the committee that budget authorities in the executive branch "specifically prohibit present officials at the agency from speaking out publicly as enthusiastically as they would like about the need for more funding," a predicament that he said he "used to squirm about."

And he expressed the hope that the public "will know when its [FDA] officials express satisfaction with their budget allocations, that they have their fingers crossed beneath the witness table."

Frank Young, former FDA commissioner from 1984 to 1989, who initiated user fees on the pharma side, handled the fast-track approvals for AIDS drugs and is now CEO of the Cosmos Alliance (Washington), said that the agency is "the single most important consumer agency in the world" and that much of the world "follows FDA."

But he too said the agency is suffering from neglect and a workload greater than its resources.

Genomics, proteomics and nanotechnology are among the new challenges "that cannot be addressed" without more funds, Young said. Research at the Center for Biologics Evaluation and Review "has been eviscerated through the recent reorganization, and is almost non-existent" at the Center for Drug Evaluation and Review (CDER), he said.

FDA "needs much more than a bandage," according to Young, describing the turnover in commissioners as "scandalous." He characterized the recruitment process for the commissioner's position as impeded by "months and months of foot-dragging" on the part of Congress and recommended an appointment process without Senate review, as well as a six-year term.

Young said that unfunded mandates need to be kept to a minimum, citing the case of the Hatch-Waxman Act, which deals with challenges to drug patents. "We had great problems in the early days of the Hatch-Waxman Act, and I think that needs to be looked at."

Young called establishment of the FDA budget by the House Agriculture Committee "an historical accident, and silly," adding that Congress should consolidate the committees with FDA oversight into fewer committees.

Also present at the meeting was current FDA commissioner Andrew von Eschenbach, MD, who said he is "no stranger to the radical changes" in medical science. And he suggested that what is needed is to rewire the way the agency works rather just to "repair the FDA of old."

He said that the appointment of Janet Woodcock, MD, to the position of chief medical officer will assist the agency in its efforts to further the agency's mission, especially in the development of "a science of safety."

He cited two guidances published earlier this year on advisory panel membership and conflicts of interest as well as "a series of changes designed to effect true culture change that will strengthen the drug safety system" and reinvigorate managers and staff at CDER and CBER.

As for devices, von Eschenbach made reference to the Critical Path Initiative and the "draft guidance on the use of Bayesian statistical methods to design more efficient clinical trials." And he said that Congress should pass the user fee reauthorization bills "without delay."