Reply #8: FDA damned if it does, damned if it doesn't

[ozymandius]

Stung by criticism that it was too cozy with the industry, the agency got tougher after Vioxx. Now who's upset? Big Pharma. Fortune's John Simons examines an embattled regulator.

(Fortune) -- The FDA just can't win. After years of public ridicule and congressional scrutiny, the Food and Drug Administration is taking a tougher stance against drugmakers in its review of new medicines. That new cautiousness, however, rankles its most powerful constituents: Big Pharma CEOs who charge that the agency is standing in the way of new medicines - and progress.

So is the FDA really to blame?

The agency's critics are vexed about recent reports that show FDA regulators have approved only 15 novel medicines so far this year - a pace that will likely match a 10-year low reached in 2002. Big Pharma CEOs contend that the FDA has become too anxious and hyper-vigilant about safety, requiring reams of additional data before it can make a decision.

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If Big Pharma is feeling more put upon, there is one big change to which the FDA will admit. FDA has two main duties as it relates to medicines: pre-marketing evaluation and post-marketing observation, which includes, for instance, monitoring advertising practices and collecting ongoing safety data. FDA officials contend that in the wake of 2004's Vioxx recall, when Merck withdrew its wildly popular painkiller over concerns that it caused heart attacks, the FDA has become more vigilant in its post-marketing oversight of drugs.

http://money.cnn.com/2007/11/08/magazines/fortune/simons_fda.fortune/index.htm?postversion=2007110905