FDA Allows Drug Reps to Give Articles on Off-Label Use

Despite objections from vocal opponents, the Food and Drug Administration (FDA) issued official rules in January to allow pharmaceutical and medical-device companies to distribute to health care professionals who prescribe medications reprints of journal articles and reference publications that describe unapproved uses of a drug or product.

Although companies are legally barred from promoting their products for off-label indications, the FDA Modernization Act of 1997 allowed companies to give out reprints of articles published in peer-reviewed medical journals to physicians until 2006, when the law expired. The lack of guidance on this practice during the past few years had created a legal vacuum that prevented this practice.

The new guidelines revive the earlier rule and allow industry reps to again distribute medical and scientific journals and refer to texts that discuss off-label indications. However, company salespersons are still not allowed to directly discuss or promote unapproved use of drugs and medical devices with health care professionals.

The official guidance document defines a medical or scientific journal article as one that is “published by an organization that has an editorial board that uses experts” who “objectively select, reject, or provide comments about proposed articles” and that should be peer reviewed according to established policies. The guidelines do not limit these publications to ones reporting on primary research studies, but apply to reviews, commentaries, and meta-analyses.

Journal supplements and special publications funded in whole or in part by the maker of the product described in the articles do not qualify as permitted reprints for distribution, according to the guidelines. However, if the authors have financial relationships with pharmaceutical or device manufacturers or the study was sponsored by manufacturers, the publication is not disqualified as long as potential conflicts of interest and bias are disclosed.

A reference publication should be something “generally available in bookstores or other independent distribution channels where medical textbooks or periodicals are sold.” Moreover, the reference should not be“ edited or significantly influenced by a ... manufacturer or any individual having a financial relationship with the manufacturer.”

The rule also requires that the information distributed in the reprints should not “be false or misleading” and not “pose a significant risk to the public health, if relied upon.” In addition, a reprinted article “should not be physically attached to any promotional material the sales representative uses or delivers during the [physician] office visit,” the document says.

These FDA recommendations are guidelines and not legally binding.

A year ago the draft version of the guidelines received much criticism from Rep. Henry Waxman (D-Calif.) and advocacy groups (Psychiatric News, March 21, 2008), who felt they would give industry a loophole to promote their products while bypassing the regulatory evaluation and approval process, thus posing safety risks for the public.

“Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” is posted at<www.fda.gov/oc/op/goodreprint.html>.▪