FDA needs a lot of work to retain watchdog status

The Food and Drug Administration, which has had a tough month by any standard, is on the defensive in response to numerous stakeholders questioning its ability to perform as a watchdog in its current form.

The Food and Drug Administration, which has had a tough month by any standard, is on the defensive in response to numerous stakeholders questioning its ability to perform as a watchdog in its current form.

FDA commissioner Andrew von Eschenbach was hauled before the House Committee on Oversight and Government Reform to discuss Avandia, GlaxoSmithKline's diabetes drug that some studies say may increase the risk of heart failure. Despite the FDA announcing it would put its strictest warning on the drug, committee chair Rep. Henry Waxman (D-CA) said, "Avandia is a case study of the need for reform of our drug safety laws."

In addition, a former safety supervisor claimed she was reprimanded a year ago for advocating the strictest warning for Avandia, and an FDA spokesman was accused of using his government account to send e-mails reflecting his personal views.

These recent missteps and controversies have painted the FDA as an agency in chaos. As reported in PRWeek (June 11), the FDA plans to form a new advisory committee to address risk communications, which will include healthcare communicators and PR professionals. And this week, it launched a Web page that will put a variety of consumer health information in one location, instead of scattered throughout its site.

These steps can only serve as the beginning. The FDA should hire professionals in all departments, including PR, who do not have a long history working for pharma; form a permanent communications committee, independent of both big pharma and internal influence, to advise it in matters that would benefit the public; and engage the public on issues that can be openly discussed, like the future of healthcare. Otherwise, concerns that the watchdog needs its own watchdog will never fade.

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