The Times ODs at the FDA.

Media criticism.
Dec. 7 2004 7:09 PM

The Times ODs at the FDA

The root of all pharmaceutical evil, the paper finds, is an industry user fee.

(Continued from Page 1)

What about Vioxx? The FDA approved Vioxx in May 1999 and didn't document safety issues worthy of a ban until this year. That means the drug was on the market for about five years, roughly the same amount of time the fully funded safety cops took to blow the whistle on Seldane. If reduced budgets have slowed safety cops in their appointed rounds, the Times' Vioxx example offers no such vivid proof.

To be sure, the Times article cites anonymous "top agency officials" who dispute the idea that the user fee deal perverts the approval process. They tell the Times that the ratio of drugs withdrawn to drugs approved has remained steady for decades. But why aren't they speaking on the record? They're discussing ratios that should be publicly available, so what are they? While we're on the subject, how many drug labels were amended with stronger warnings before 1992, and how many after the 1992 user fee agreement went into effect?


The subdued hysteria of the Times article might lead you to believe that drug fast-tracking has resulted in an avalanche of new—and potentially dangerous—medicines. Not so. A Harvard-Michigan study from December 2003 found that millions in user fees from drug companies haven't sped the approval of new drugs any more than federal funding increases did in the past. The report also found no evidence that industry funding of fast-track approvals prejudices the process in favor of drug companies. Taking the wind out of the Times'huffing and puffing is this feature article published six years ago, in which critiqued the FDA pact with similar language. If the FDA user fee is news, it's old news.

The late Detroit News columnist Warren T. Brookes quarrelled with conservative journalists who believed the national press corps was liberal. In a 1989 Cato Institute lecture, he declared the press was biased but biased in favor of the state. Journalists, by and large, were "committed to the promotion of an ever more intrusive government presence in every aspect of our lives, except, of course, the press and the media themselves." The symbiotic relationship between the government and the media allowed the press to grow in power and importance whenever the government grew. The press corps' enduring commitment to the government's wisdom, he said, was "motivated by institutional self-interest." If Brooks were alive today, I suspect he'd use the Times story as a heavy-breathing example of his theory.

The FDA user fee may be a boon for drug consumers, a bane, or just a wash, but until the Times produces copy more worthy of a more outgoing headline—and a more declarative article—I remain agnostic.


Somewhere out there, somebody misses their Seldane, which the FDA ultimately drove off the market. Is that someone you? Drop me a line at (E-mail may be quoted by name unless the writer stipulates otherwise.)


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