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
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
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>.▪