Ever wonder how the Food and Drug Administration decides to approve a drug or handle reports of side effects? You’re not alone. Much of what the agency does is shrouded in secrecy, often at the behest of companies seeking to protect their business interests.
But if a task force being convened by the new management at FDA makes headway, you may get a chance to see a little bit more of what goes on behind the regulatory curtain, The New York Times reports. It may, for instance, become harder for companies to keep the lid on some material, such as clinical trial results on file at the FDA, with the claim that it is a trade secret.
In a statement, FDA Commissioner Margaret Hamburg said the agency is responding to a pledge by President Obama to increase the openness of government. Hamburg’s looking for recommendations for “ways to make more information available and foster better understanding of decision-making.” Have ideas? The agency will hold a public meeting later this month to get your input.
We’d suggest a good starting point would be the agency’s Freedom of Information Division. Last year, more than two-thirds of reporters responding to an Association of Health Care Journalists survey said they had stories held or left unpublished because the FDA didn’t respond to FOIA requests fast enough.
The FDA launched its “Transparency Blog” late today with introductory notes from HHS Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg. It should be noted that the blog does not reveal who will be doing the actual blogging. (update from Pia Christensen)