Sunday, February 17, 2008

Impending Changes on the Promotion of Off-Label Use

FDA is an agency within the United States Department of Health and Human Services and is mandated to regulate through its subdivisions Center for Devices and Radiological Health (CDHR) for medical devices and Center for Drug Evaluation and Research (CDER) for drugs with respect to safety and efficacy.  In addition to safety and efficacy, FDA regulates almost every facet of prescription drugs and use of medical devices, including testing, manufacturing, labeling, advertising and marketing.   The intent is to protect the public against fraudulent claims and to ensure safety of the consumers.  The intent of FDA is not to regulate the practice of medicine.  Within this context, a drug or medical device that has been approved by FDA for a specific use can at the discretion of the physician be legally used for conditions other than those approved by FDA.  Such practice is called the off-label use of an FDA approved product and the rules of the game are changing, at least for the companies. 

Companies have in the past have been prohibited to promote drugs or medical devices for uses that have not been specifically approved by FDA.  The leeway for companies to make such promotions may widen slightly.  The new guidelines (draft for public comments) would permit manufacturers and companies to distribute reprints from peer-reviewed journal articles.  Several categories of reprints are prohibited under this guideline including special supplements, letters to the editor, early-stage trials in healthy patients, and articles that are "inconsistent with the weight of credible evidence."

This move by FDA is not without controversy.  As reported in WSJ Health Blog Randall Lutter, FDA deputy commissioner for policy stated that  "Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,".  Lutter maintained that "This guidance also safeguards against off-label promotion."

Not everyone agrees with this latest intended move by FDA to what some deemed as facilitation of off-label use.  A particularly vocal opponent of this FDA initiative is Congressman Henry Waxman, a California Democrat.  He wrote a cautionary letter to the FDA citing danger of such a move as potentially short circuiting the FDA regulatory process and opens the door to abusive marketing.  He quoted Senator Estes Kefauver warning that if promotion of unapproved uses was allowed, "the expectation would be that the initial claim would tend to be quite limited, which, of course, would expedite approval of the new drug application."  The implication here is that companies would then "promote" and "widen" the unapproved indications through the distribution of reprints from peer-reviewed journal articles touting the off-label use of such drug or device.  The controversy remains if this is after all necessarily a bad thing and not to the interest of the public.


Wall Street Journal has an excellent article on this issue.

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