FDA wants to open up

June 3, 2009 – 11:15 am by Michael Christel

The launching of the FDA Transparency Task Force is welcomed news for those who have long complained that the agency is too secretive when it comes to sharing vital drug information, even to the point uninformed patients have been harmed.

However, as this report notes, while the goals for the program are ambitious and, dare I say, admirable, ratcheting open the lines of communication between FDA and the public will be complicated. And it won’t happen right away. Historically, the review and approval of new drugs and medical devices has largely been a closed-door process, with their developers protected by trade secrecy. Changing that, experts stress, would have ramifications for thousands of companies as well the American public. It “would be an extremely difficult legislative path,” Peter Barton Hutt, a former general counsel to FDA, points out in The Times story.

Nevertheless, FDA’s willingness to take a hard look at transparency problems is a positive sign and a serious response to president Obama’s January memo requiring government agencies to promote transparency and openness and “disclose information rapidly in forms that the public can readily find and use.”

Such a forum, in theory, should only help FDA’s embattled reputation.  Although opinions have improved somewhat in 2009, almost half of the respondents in a recent national poll said they believe the agency does a bad job when it comes to monitoring the safety and effectiveness of new prescription drugs. According to the poll, only 11% believe FDA does an “excellent” job of handling recalls of prescription drugs.

FDA realizes it needs to regain credibility within the medical community and among consumers. Initiatives like the Transparency Task Force are a good place to start.

“The agency can and should communicate with the public in a way that provides more clarity about agency activity and processes - not less,” FDA Commissioner Margaret Hamburg told reporters.

In doing so, the agency said, it will seek suggestions from employees, stakeholders, and the public on ways to become more transparent. Talk about clinical trial reform. This one might be a doozy if it has legs.