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FDA Proposal Easing Off-Label Use Rules Sparks Rebuke From Congressman

Dec 3, 2007 | Parker Waichman LLP

The Food & Drug Administration (FDA) has proposed new rules governing the way drug companies and medical device manufacturers can use journal articles to promote off-label uses of their products.  But the FDA off-label use proposal already has one lawmaker concerned, as the new rules could leave consumers with fewer protections against defective drugs and medical devices.

Once a drug or medical device has been approved by the FDA, doctors are free to prescribe it as they see fit. However, drug and medical device companies are prohibited from advertising off-label uses.  In 1997, Congress created a temporary exception to the off-label marketing rule by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians.  Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article.  That exception expired in 2006.

Now, the FDA wants to loosen the expired rules even further.  Under a draft proposal prepared by the FDA, drug and medical device manufacturers could distribute unabridged reprints of research from reputable medical journals as long as the articles were not written, edited or otherwise "significantly influenced" by the manufacturers or people with financial ties to them. No other promotional materials could be attached to the reprints, which would have to be labeled as describing uses for the products that have not been approved by the FDA.  The FDA would not have to review the articles prior to their distribution.

The FDA rationalized the new guidelines by writing that off-label uses or treatments are important and may even constitute a medically recognized standard of care."Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications," the FDA proposal said.

But Representative Henry Waxman (D-Calif) does not agree with the FDA's rational, and said the agency's proposed guidelines will leave consumers at risk.  In a letter to the FDA, the Congressman said that creating a new path to promote off-label uses could improperly influence doctors' prescribing habits.  Waxman wrote that the new proposal "would open the door to abusive marketing practices that will jeopardize safety, undermine public health and lead to an increase in unapproved uses of powerful drugs."  Waxman also argued that the new FDA off-label use proposal would  discourage drug companies and medical device makers from conducting definitive scientific studies and seeking  formal FDA approval for alternative uses of drugs and devices if they could profit from off-label uses without such studies.  Finally, Waxman pointed to several high-profile cases in which drugs such as Vioxx were hyped in journal articles that either underreported dangers or overstated benefits.


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