FDA on Spin Cycle
This article was originally published in RPM Report
Executive Summary
An FDA advisory committee call for immediate action on attention deficit/hyperactivity disorder drug safety leaves the agency scrambling to defend itself.
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FDA's Media Frenzy
The Food & Drug Administration is trying to reverse its negative image tide by adopting a more proactive relationship with the news media. Over one five-week period alone, FDA held almost a dozen media teleconference calls on drug- or biologic-related issues. The extra attention is either good or bad news for manufacturers, depending on the subject of the media briefing.
Lost in Translation: Interpreting Advisory Committees
FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.
Lost in Translation: Interpreting Advisory Committees
FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.