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FDA to offer guidance to companies on marketing drugs for unapproved uses
by Matthew Perrone, THE ASSOCIATED PRESS
February 16, 2008

WASHINGTON - The U.S. government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some legislators as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.

Since the expiration, companies have continued the practice, but questioned its legality.

Off-label prescriptions account for an estimated 21 per cent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine.

Under FDA's proposal, posted online Friday, the agency says it will not punish companies for distributing literature on off-label uses if they adhere to certain practices.

Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by the company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.

According to FDA "these off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care."

Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the article's accuracy could be reviewed. Under the new proposal, drug companies don't have to submit articles to the FDA.

Legislators worry companies will over-promote potentially dangerous uses.

Representative Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said the rules would jeopardize the public unless FDA kept closer watch over the materials companies distribute.

A spokeswoman for Waxman said his staff is reviewing the draft and could not immediately comment.

The agency still has time to revise the rules. According to its website, FDA will accept comments on the proposal for two months before writing final guidelines.


Legislators worry companies will over-promote potentially dangerous uses.

This is a broad statement which might exaggerate reality.

The assumption is that physicians blindly follow the marketing message delivered by pharmaceutical companies or prescribe off label therapy carelessly.

In fact most physicians are conservative in making changes to their therapeutic approach, in particular to adopting off label therapy.

The quality of the literature reporting off label uses and the clinical experience of local or respected specialists has a greater impact on the whether physicians adopt off label therapy.

Off label uses often become indicated (approved) uses once a sufficient amount of clinical experience is collected. Off label therapy is the seed of progress.

David Baxter PhD

Late Founder
TSOW said:
Off label therapy is the seed of progress.

Exactly. There are inummerable examples where medications designed for one purpose have turned out to be effective (sometimes even more effective) for other purposes. While the FDA is charged with overseeing the marketing of pharmaceuticals, including the scrutiny of claims made about the use of drugs by manufacturers, I would hope that whatever policies the FDA adopts do not end up restricting progress.

For example, no one wants another thalidomide tragedy. On the other hand, it's important to remember that while this medication caused numerous severe birth defects in babies when prescribed to pregnant women at high risk for miscarriage, it has since been found to be effective when used in the treatment of leprosy, Crohn's disease, and multiple myeloma and various other forms of cancer.
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