New Procedures for FDA Advisory Panels Benefit Public Health, Says Watchdog Group

April 28, 2010

April 28, 2010 — New procedures for expert panels that advise the US Food and Drug Administration (FDA) on medical device approvals will benefit the public by focusing panel members on matters of science, rather than regulation, and reducing the possibility of undue influence by FDA staff, the head of a consumer watchdog group told Medscape Medical News.

"The changes will allow the FDA to get the information it wants most from the panels — what are the benefits and risks of a product," said Diana Zuckerman, PhD, president of the nonpartisan National Research Center for Women and Families, which specializes in health issues. "Then the FDA can decide what to do about approval."

The FDA has 49 advisory committees and panels. All 18 panels are subsets of the Medical Devices Advisory Committee, covering fields that range from radiology to immunology.

In 2006, Dr. Zuckerman's group released a report stating that many of the FDA's advisory committees for devices and drugs function as "rubberstamps for approval almost every time they meet." Too often, the report states, committee members voice serious doubts about the safety and effectiveness of a product only to recommend that the FDA okay it for marketing. The report quotes a committee member as saying, after casting a "yes" vote, "Don't take that to mean that I don't have grave concerns about the safety of this drug."

The new procedures, announced April 26, address some of the issues raised by the report. Beginning May 1, 2010, device advisory panels will no longer vote on whether to recommend product approval or conditions of approval. Instead, they will take a vote on a product's safety and effectiveness, as well as how its benefits stack up against its risks. An FDA spokesperson told Medscape Medical News that panels would vote on 3 different questions, which would follow along these lines:

  • Do the data included in the product submission provide substantial evidence of safety for the requested indication?

  • Do the data included in the product submission provide substantial evidence of effectiveness for the requested indication?

  • Do the available data indicate that the benefits outweigh the risks of the device when used for the requested indication?

This method of voting represents the most important change, said Dr. Zuckerman, because up until now, panel members who have had reservations about a device frequently would attempt to compromise by supporting it only under certain conditions, such as postmarketing studies or label warnings. However, the FDA usually does not impose conditions recommended by advisory panels nor enforce them if they are adopted, said Dr. Zuckerman, noting that many of these conditions are unenforceable or vaguely worded.

The new format "will allow panel members to address issues related to their expertise instead of regulatory issues that may be unfamiliar to them," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a press release.

Another change will discourage lockstep voting by advisory panels. Instead of voting by a show of hands, panel members will do so electronically. Their decisions will still be public, but members can make them "without immediate influence by other votes," according to Dr. Shuren.

One panel member can unduly sway colleagues with his or her vote, said Dr. Zuckerman. "People follow the leader like sheep." That kind of influence is alarming, she said, if the pivotal panel member has financial ties to the product manufacturer.

Advisory Panels Will Now Hear FDA Minority Reports

The new rules for advisory panels also extend to the FDA staff members who brief panels on their clinical and statistical review of a medical device under consideration. In a departure from past practice, these scientists will no longer include comments about a product's "approvability." Dr. Zuckerman said that FDA staffers do not baldly recommend that a product be okayed, but that their presentations nevertheless can steer panels in one direction or another.

Steering is also less likely to occur with a provision that calls for more nuanced staff presentations. FDA reviewers have traditionally "presented a unified, consensus analysis of supporting data," the FDA press release states. "Now reviewers will present together with data and analysis the range of scientific opinion in the group."

This approach will allow FDA staff to offer minority reports about a medical device, said Dr. Zuckerman, and avoid the appearance that upper management is squelching dissident points of views. A number of FDA physicians and scientists have complained to Congress and President Barack Obama that "corrupt" managers have suppressed scientific evidence showing that some products coming to the agency for approval are unsafe.

To the head of the FDA's Orthopedic and Rehabilitation Devices Panel, the changes for advisory panels signal that the agency is correcting its course.

"The movement is to return to science," said John Kelly IV, MD, an associate professor of clinical orthopedic surgery at the University of Pennsylvania School of Medicine, Philadelphia. "We are here as scientists. That makes things more pure and clean.

"It's back to the basics."


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