Is off-label promotion off the mark?

Most people know that off-label use of drugs is rampant, but not everyone may know its extent or history. In the WSJ article U.S. FDA gives boost to off-label drug use, the authors discuss the proposed FDA guidance which would allow drug and device companies to disseminate articles that discuss unapproved uses.

“The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.  Drug makers are generally expected to welcome the proposal because it clarifies a blurry legal area. At least under certain conditions, it promises a haven for a controversial promotional practice. It also contains an argument from the agency that may help the companies in court cases about marketing practices.”

Interestingly, the authors failed to mention that this really isn’t a new guideline at all.  In fact, in the FDA press release and draft guidance, they gave the history and context for this proposed guideline which was enacted in 1997 and expired in 2006:

“Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired on Sept. 30, 2006.”

Furthermore, it gives very specific conditions that must be met, including detailed descriptions of the “types of reprints/articles/reference publications and the manner in which to disseminate scientific and medical information.” For example,

“Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.”

However, the new guidelines omit some previously outlined safeguards. According to a Modern Healthcare article,

“[The previous FDA guidance] had required companies to submit medical journal articles in advance to the FDA and agree to file within three years a supplemental new drug application for the off-label use it wanted to promote. Yet, these important safeguards are nowhere to be found in the new proposed guidance, said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a written statement.”

I believe that this is an important guideline that should be closely examined.  The intent is to provide physicians with “truthful and non-misleading” information that can be used for evidence-based decision making.  I would support this guideline with the appropriate safeguards in place to ensure patient safety and promote public health.

Feel free to send your own comments and suggestions to the FDA by April 15, 2008 to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.

February 21, 2008

Leave a Reply

Your email address will not be published. Required fields are marked *