A new panel will educate consumers about the risks of using drugs, federal regulators said Monday, two days before a hearing on why the public was not told that a popular diabetes medicine might cause heart attacks.
The Food and Drug Administration’s new Risk Communication Advisory Committee will be made up of 15 experts and patient advocates who will help communicate safety information on drugs, medical devices and other regulated products, according to a notice posted on the agency’s Web site. The panel’s initial charter will last two years.
The committee was among recommendations the agency received in September from the U.S. Institute of Medicine, an advisory group, the FDA said. Congress, doctors and consumer organizations have criticized the agency for failing to quickly identify and disclose risks linked to medicines such as GlaxoSmithKline PLC’s diabetes pill Avandia.
A study released last month by the New England Journal of Medicine found that patients taking Avandia were 43 percent more likely to have a heart attack. The FDA says it is still reviewing data on Avandia’s risks and has not reached conclusions.
London-based Glaxo said more reliable, longer-term studies found no greater risks than for other diabetes drugs. Avandia is the world’s top-selling diabetes pill and had $3 billion in sales last year.
The House Oversight Committee has scheduled a hearing for Wednesday to evaluate the adequacy of the FDA’s actions in the Avandia case.
The agency’s oversight of drug safety has been under scrutiny since Merck & Co.’s Vioxx had to be removed from the market in 2004 after heart risks were discovered five years after the drug’s introduction.
“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 Sandy Walsh, a spokeswoman for the FDA.
The agency already has a Drug Safety and Risk Management Advisory Committee that has more expertise to review clinical data, she said.
Members of the new panel will be required to have scientific expertise in related fields or be patients, patient advocates or health-care professionals who can provide experience-based insights, according to the FDA’s notice.
