Did pharma asked FDA for rule change?

Are drug companies behind the FDA's proposed rules for using journal articles to market drugs for off-label use? The always-up-to-something Rep. Henry Waxman, chairman of the Committee on Oversight, suggests that it's so. Pharma officials met with the FDA last April to twist a few arms, he says, and then, as suggested, the agency developed new, more relaxed rules for marketing with journal articles.

Here's the background: Under a law that expired in 2006, sales reps were allowed to distribute reprints of journal articles that support drug uses that haven't been given the FDA's official blessing. Many companies continue to do so, even though their legal basis for it is gone. At that meeting in April, they asked FDA chief Andrew von Eschenbach and several others for help, because now that the law has expired, federal prosecutors were sniffing around. The new rules would protect those companies from prosecution and would allow the practice to continue at the FDA's say-so. And unlike before, companies wouldn't have to get the agency's go-ahead on each article, and they wouldn't have to restrict the reprints to off-label uses they'd already asked the FDA to approve.

With a little arm-twisting of his own, Waxman got the FDA to produce a memo about the April meeting. Now he's asking for more documents related to the new guidelines. "The guidance would shelter drug companies from responsibility for dissemination of articles on unapproved uses to a far greater extent than at any other time in FDA's history," he wrote in a letter to von Eschenbach, "and would undermine the law requiring companies to seek approval before marketing a drug or device." We'll see what the FDA does next.

- see the FDA's meeting memo (.pdf) and Waxman's letter (.pdf) in response
- read the report from BusinessWeek
- see the draft of the new rules Waxman released last fall

Related Articles:
Too much off-label regulation? Report
Rep decries off-label marketing "loophole." Report

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