Consumers may learn more about the safety of drugs and medical devices that are regulated by the U.S. Food and Drug Administration as part of President Barack Obama's push for more openness in government.
A new "transparency task force" of top FDA officials will recommend ways to better share information about approval decisions, enforcement actions and recalls, according to a notice posted on the agency's Web site.
Lawmakers, doctors and consumer groups say the FDA failed to disclose heart risks with GlaxoSmithKline Plc's diabetes pill Avandia and Merck & Co.'s painkiller Vioxx. New FDA Commissioner Margaret Hamburg and deputy Joshua Sharfstein pledged in the New England Journal of Medicine on May 26 that they would disclose more information to "enhance the work of the FDA and its credibility with the public."
"Over the years, there have been complaints made about FDA's lack of transparency," Hamburg said today on a conference call with reporters. "While the agency cannot disclose all types of information, I believe the agency can do a better job of providing useful information to the public in a timely manner."
The task force, led by Sharfstein, will seek input from companies, doctors, patient groups and others during the next six months before issuing a report to Hamburg. The first of two public meetings on the topic is scheduled June 24 in Washington, according to the notice.
The task force may consider a "range of recommendations," including some involving the disclosure of confidential data or clinical studies under review by the FDA, which would require new laws and may take more time to implement, Hamburg said. Other issues may be tackled "swiftly" by changing the manner in which information is made accessible to the public, she told reporters.
Steve - we will be tracking this very closely.
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