Healthy Skepticism Library item: 10346

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Larkin C.
New U.S. Panel to Tell Public of Drug, Device Risks
Bloomberg News 2007 Jun 4
http://www.bloomberg.com/apps/news?pid=20601202&sid=aZq13_5Ns1bw&refer=healthcare

Full text:

U.S. regulators, facing a hearing in Congress on why they didn’t alert consumers to heart risks with a popular diabetes drug, said they will form a panel of outside advisers to help communicate safety information to the public.

The Food and Drug Administration outlined the new 15-member Risk Communication Advisory Committee in a notice posted today on the agency’s Web site. The FDA hasn’t determined precisely how the panel will operate, though it probably will address ``fairly broad’‘ practices rather than specific products regulated by the agency, spokeswoman Sandy Walsh said in an e-mail.

Creating the committee was among recommendations the agency received in September in a report commissioned from the U.S. Institute of Medicine. Members of Congress, doctors and consumer groups have criticized the FDA for failing to identify and disclose risks linked to medicines such as GlaxoSmithKline Plc’s diabetes pill Avandia.

``This is a critical time for the FDA amid reports that they frequently ignore the recommendations of scientific experts,’‘ said Representative Rosa DeLauro, a Connecticut Democrat, in an e-mailed statement today. ``I am hopeful that the FDA will allow this advisory committee to perform its duties adequately and intend to closely monitor its work as it moves forward.’‘

An analysis released on May 21 by the New England Journal of Medicine found patients taking Avandia were 43 percent more likely to have a heart attack. The House Oversight Committee has scheduled a hearing for June 6 to evaluate the FDA’s decision to withhold data received from London-based Glaxo while the agency could complete its own review.

Avandia Review

Regulators have said they need to review results from other studies before deciding whether to take any action on Avandia. Glaxo says more reliable, longer-term studies have found no increased risks. Avandia is the world’s top-selling diabetes pill with $3 billion in sales last year.

The FDA’s oversight of drug safety has been under increased scrutiny since Merck & Co. removed Vioxx from the market in 2004 because of heart risks and studies linked antidepressants to suicide risks for children.

The new panel will advise the FDA on how to convey the risks and benefits of products it regulates, such as drugs, medical devices and vaccines, so that consumers can make informed decisions. The committee’s initial charter will last two years.

``It is too soon to say how we will use this committee to provide insight into the impact of risk communication surrounding specific products,’‘ said Walsh, the FDA spokeswoman. The agency already has a Drug Safety and Risk Management Advisory Committee with more expertise to review clinical data on specific products, she said.

Panel Members

Nominations for the new Risk Communication panel should be submitted to the FDA within 45 days after the agency publishes a notice in the Federal Register tomorrow.

Members must have expertise in risk communication, social marketing, health literacy, journalism, bioethics or other relevant sciences, the FDA said. Some patients, consumer advocates or health-care professionals also will be chosen for the committee.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net .