Washington Editor

WASHINGTON - Public confidence in the FDA is waning, according to an opinion poll released amid a pair of Senate committee hearings this week on the agency's drug approval process and safety record.

"We have seen America's confidence in the FDA decline in recent months," said Celinda Lake, president of a Washington-based survey company called Lake, Snell, Perry and Associates Inc. "An overwhelming majority of Americans want to either increase FDA's capacity for oversight and regulation, or at least keep it at current levels."

The agency has found itself under fire with regard to drug safety after questions surrounding the COX-2 inhibitor class of pain drugs and non-steroidal anti-inflammatory products. The market withdrawal of the multiple sclerosis drug Tysabri this week, which occurred after the poll was taken, cannot have helped the FDA's image.

Lake, the survey's chief pollster, backed her statements with a number of results on confidence in the FDA's ability to protect the public. The poll surveyed 1,000 people, with an error margin of plus or minus 2.5 percent.

Overall, 14 percent said they had a great deal of confidence in the FDA. Two-thirds favored an independent body to conduct a full review of all of the agency's practices and procedures, while 70 percent supported strengthening the FDA's collection and reporting process on drugs and devices that have been found to cause harm after approval.

Opinions were mixed on the issue of sponsor company fees collected by the agency for its reviews, but Lake said the poll showed that by an overwhelming margin, "the industries regulated by the FDA have too much influence over the agency's decisions."

That feeling was echoed by Arthur Levin, the director of the Center for Medical Consumers, who in commenting on the poll's finding also referred to conflict-of-interest issues that arose following the FDA's recent three-day hearing on COX-2 inhibitors. After the meetings, it was revealed that a number of people who sat on the agency's advisory panel, of which Levin was a member, had consulting relationships with the pharmaceutical companies that produce the pain reliever drugs called into question.

"Whether it's real or perceived," he said, "it's just not a good thing for the public to see industry having too much influence over the FDA process."

Lake said the cardiovascular risks with COX-2 drugs have brought regulatory worries to the forefront of political opinion right now, concurrent with other high-publicity issues, such as Iraq and Social Security.

"I've been working on FDA issues for 15 years, and it used to be just mentioning [the agency] made people's eyes roll back in their heads," said Diana Zuckerman, the president of the National Research Center for Women & Families in Washington. "That is just not what's happening now. All you have to do is say Vioxx' and everybody knows what you're talking about. It really has become a very salient issue for a lot of people."

The FDA has caught the attention of Congress. The Senate's Health, Education, Labor and Pensions Committee held two hearings in three days this week on the FDA.

Speaking at Thursday's hearing, Raymond Woosley, president of the Critical Path Institute at the University of Arizona at Tucson, advocated a staged approval model by which a product would be marketed on a limited basis to selected patients, while further testing occurs in a broader population. That, he said, "would allow a pharmaceutical company to begin marketing its product earlier with a lower total capital investment and at a time when much more of the patent life is still in effect." He added that the method would "make it possible to detect any serious life-threatening problems earlier before millions have been exposed, reducing the frequency of litigation and class-action lawsuits."

Another speaker during the Senate hearing, Bruce Psaty, argued in favor of requiring large, long-term trials, creating an independent "Center for Drug Safety" within the FDA to oversee drugs after approval, and strengthening post-marketing safety systems in the U.S. by improving the FDA's MedWatch system. He works as a practicing general internist and cardiovascular disease epidemiologist in Seattle.

Defending the FDA was Sandra Kweder, the agency's deputy director of its Office of New Drugs. She pointed to recent initiatives to strengthen safety, such as the Institute of Medicine study to evaluate the current drug safety system, improving a process within the FDA's Center for Drug Evaluation and Research to help ensure that dissenting opinions are formally addressed, and the recently announced Drug Safety Oversight Board, which was established as an independent body to manage drug safety issues.

Kweder also defended the agency's relationship with the drug industry vis- -vis the Prescription Drug User-Fee Act, noting that outside research confirmed the FDA's analysis that there are no significant differences in the rates of safety withdrawals for drugs approved before PDUFA compared to drugs approved during the PDUFA era; at the same time, the average FDA drug review time has declined by more than 12 months. She added that the agency is adding black box warnings sooner these days than before PDUFA.

But despite her efforts, Kweder's assertions conflicted with much of the public opinion found in the poll. Patient advocate Abbey Meyers, who commented on the poll's findings and also testified before the Senate committee, called the FDA "more secretive than the CIA."