A tougher, more transparent FDA? Apparently, the agency is trying. Today, FDA is holding its first public meeting on transparency, focusing on ways the agency "can make understandable and useful information available to the public." Just how much and which information--those are the big questions the agency task force will seek to answer. Today's all-day meeting includes comments from industry associations, not-for-profits, and consumer advocates, among others.
Deputy FDA chief Joshua Sharfstein (photo) heads up the agency's transparency initiative, and though he's said that some info will have to remain confidential, "greater transparency" will necessarily mean "less confidentiality." Manufacturing data? Clinical research data? Now's your chance to weigh in, as the agency gathers opinions ahead of a task-force report.
Meanwhile, Time magazine takes a look at the agency's regulatory charges and performance, asking whether the FDA is getting tougher. In its rundown of its regulatory mission, the story highlights case studies that characterize the FDA as slow to act, whether because of red tape, lack of power and funding, or industry influence. The usual suspects--Zyprexa, for instance--make an appearance. But Time seems to conclude that the FDA is finally lumbering toward a more active approach.
Consider the recent warning on Zicam: Matrixx Products in 2006 settled liability suits over patients' loss of the sense of smell, but the FDA didn't make a peep about the potential side effect until last week--which the magazine sees as evidence of FDA Commish Maragaret Hamburg's (photo) more aggressive approach. Agree or disagree? Let us know.
- check out the task force meeting agenda
- see the transparency story in Cosmetics Design
- read the Time article