Medical Device Daily

WASHINGTON — Four former FDA commissioners, whose tenures atop the agency lasted from the 1970s until the early part of this decade, have called for more federal funding and fewer political intrusions to strengthen the FDA's capabilities and integrity, among other suggestions made during a gathering last week at George Washington University.

All the speakers addressed factors that have placed the agency in the crosshairs of a variety of critics and resulted in myriad legislative proposals to change how the FDA operates. Such a dialogue is certainly timely, given the sense that some of them could stick to must-pass legislation up for renewal this year, like the Prescription Drug User Fee Act.

"What happened?" was the rhetorical question of David Kessler, who headed the agency between 1990 and 1997. "And why are we here?"

Answering, he pointed to a number of issues that have come up in recent years: confidence concerns in the wake of Vioxx's safety issues; credibility doubts that arose because of the FDA's political handling of the Plan B contraceptive product; its high rate of leadership turnover; and a fundamental failure to address the future model of drug development — that of more tailored and personalized medicine.

The so-called blockbuster model for pharmaceuticals "is not sustainable," Kessler said, and ignoring that "has gotten us into trouble."

Approving large-market drugs on studies that include many thousands of patients will continue to lead to unforeseen adverse events, especially in an era of direct-to-consumer advertising, he said. Drugmakers should retrench and focus on targeted, small-market opportunities to improve the all-important benefit-risk ratio, he added.

That, Kessler said, is "the debate that needs to happen."

Echoing similar themes were Jane Henney, who ran the FDA from 1999 until 2001, Frank Young, its leader between 1984 and 1989, and Donald Kennedy, commissioner from 1977 through 1979. They argued in favor of allocating better appropriations for the FDA, especially vis a vis escalating user fees that now account for well over half its drug review budget. In fact, given a choice of more appropriated- or user fee-generated dollars, they all sided with the former.

Noting that user fees "came at a moment of desperation" because federal funding levels were precipitously low, Young said that Congress has since "let the agency down" in terms of improving appropriations while the user fee system has mushroomed. Henney, who backed that thought and also laid blame on the White House administration for funding problems, cautioned that negative perceptions created by user fees, whether "right or not," would persist as long as drugmakers are funding more than 50% of drug reviews.

Lawmakers "ought to pay some attention" to that imbalance, she said, suggesting that appropriations oversight for the FDA should be moved from the purview of agriculture committees in Congress.

Young said the agency's performance would improve with better electronic recordkeeping, called for better defined legal authority on its post-approval oversight of drugs, urged caution on biogeneric legislation and supported a six-year term for FDA commissioners, echoing a proposal raised in last fall's Institute of Medicine report. Relative to that entire analysis, he said the suggestions would "help bandage" an agency that's been hit by criticism.

Kennedy called for a national system for epidemiology records on adverse events and also cautioned against political meddling in the FDA's scientific reviews.

All voiced support for restoring research activities within the FDA, especially relative to pharmacogenomics. On the flipside, all opposed legislation that would separate the FDA's post-approval safety group from its drug approval division, and they each opposed a suggestion to move the agency's food regulations into a new entity.

The event was hosted by the university's School of Public Health and Health Services and its Project on Scientific Knowledge and Public Policy.