The FDA may have closed the door to off-label marketing, but it's planning to open a window. Under new rules proposed by the agency, drug makers could distribute journal articles that support uses not vetted by regulators. The draft guidelines are drawing fire from Rep. Henry Waxman, chairman of the House Committee on Oversight and Government Reform, who has written the FDA demanding an explanation.
Under a law passed in 1997, drug companies have been allowed to distribute journal articles in support of off-label uses, but that law expired in September. It required drug makers to submit articles for the FDA's OK before sending them to doctors and other providers. The new, in-house rules would abandon that provision, but would require the articles to meet certain standards.
Waxman claims that the rules would "open the door to abusive marketing practices" and "lead to an increase in unapproved uses of powerful drugs." But former FDA types say those pharma-distributed journal articles are an important part of physician education. Where have we heard that explanation before?
- read Rep. Waxman's letter to the FDA (.pdf)
- see the FDA's draft guidance on the issue (.pdf)
- read the report from the Anchorage Daily News
- check out this WSJ article for more
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