Thursday, June 21, 2007

The Wrong Man for This Job

Sometimes the right person comes along at the wrong time. Unfortunately, that appears to be the case with Dr. Andrew von Eschenbach and his stewardship of the Food and Drug Administration.

Von Eschenbach was persuaded to come over from the prestigious National Cancer Institute to take the helm at FDA during troubled times. He answered the call to duty. His predecessor, Lester Crawford, pled guilty to two misdemeanors for withholding financial information related to food and drug stocks he owned (I wish I was making this up) and the public had lost trust in one of the most important federal agencies in the country. He seemed like the perfect choice to usher the agency through the final years of the Bush Administration.

With the Vioxx controversy seemingly behind the agency, it seemed like FDA had somewhat smooth sailing ahead for the twighlight years of Bush II. Uh, not so much. Results from the Institute of Medicine study on drug safety, the controversies over Sanofi-Aventis' antibiotic Ketek and GlaxoSmithKline's diabetes drug Avandia, and the re-emergence of whistleblower David Graham, among others, contributed to chipping away at FDA's credibility.

Now, more than ever, FDA needs strong leadership. And by strong leadership, I mean an authoritative voice with a clear message. I wrote a piece on this very subject in the June issue of The RPM Report. I'll let you judge for yourself: if you want to read it, click here, and as always, I would love to hear what you out there in the blogosphere have to say.

One of the misconceptions about this issue is that it's an inside-the-beltway issue. Wrong. This is a commercial issue for the pharmaceutical and biotech industries. Don't believe me? Look what the article of one clinical researcher did to GSK's stock. Would the stock have dropped billions in market cap if the docs, the media, the public and the investment community trusted FDA as the final word on drug safety? No doubt, Glaxo's stock price would have taken a hit, but a $13 billion hit in one day?

And that's why, in my opinion, FDA's credibility gap-real or perceived-ranks as the number one business problem for drug manufacturers for the foreseeable future. The credibility gap has infused arguably unprecedented unpredictability into the drug development system, and until it is somehow fixed, that unpredictability will hover over the agency, and only loom larger.

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