Did pharma ask the FDA for off-label rule change?

In the past, pharmaceutical sales reps were allowed to distribute reprints of journal articles that supported drug uses which hadn't been given the FDA's official blessing. While the law that allowed this expired in 2006, many pharmaceutical companies are continuing to distribute such articles, even though their legal permission for doing so is gone.

Now, newly-proposed FDA rules (lobbied for strongly by pharmas) would protect those companies from prosecution and would allow the practice to continue. Unlike before, companies wouldn't have to get the agency's go-ahead on each article they distributed. What's more, the pharmas wouldn't have to restrict the reprints to off-label uses they'd already asked the FDA to approve. Sounds like an effective green-light for marketing off-label scripts!

All of this doesn't please Rep. Henry Waxman, who has strongly criticized the proposed rules as giving the pharmas way too much rope. Waxman, who wrote a strongly-worded memo to FDA chief Andrew von Eschenbach on the subject, is demanding that the FDA account for its actions.

To learn more about this issue:
- read the report from BusinessWeek

Related Articles:
Rep decries off-label marketing "loophole." Report
New warning for off-label Fentora. Report

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