The Food and Drug Administration has released a draft guidance that
could allow pharmaceutical and medical-device manufacturers to distribute
reprints of published articles that discuss unapproved indication. The
document is posted on the agency's Web site for public comments.
Rep. Henry Waxman (D-Calif.), chair of the U.S. Congressional Oversight
Committee, initially released the draft guidance last November on the
Oversight Committee Web site after it was submitted to the committee. The
guidance proposed that pharmaceutical and medical-device companies be allowed
to disseminate reprints of articles that discuss indications not approved by
the FDA, as long as the information is "truthful and
nonmisleading." In his letter to the FDA commissioner, Waxman said the
draft guidance would "carve a large loophole in the law," and he
requested additional documents to justify the guidance.
While pharmaceutical companies are legally prohibited from promoting
unapproved indications for their products, the FDA Modernization Act of 1997
allowed these companies an exemption for articles that have been published in
peer-reviewed scientific journals.
The industry had been distributing journal articles including studies,
reviews, and editorials discussing off-label use of products to physicians and
other health care professionals until the law expired in 2006. The FDA
currently has no policy in place. This draft guidance may extend the rule
previously included in the 1997 law.
In a second letter to the FDA dated January 22, Waxman questioned the
industry's influence on the origin of the agency's draft guidance, citing a
meeting in April 2007 between FDA officials and industry representatives. At
this meeting, according to Waxman's letter, industry representatives urged the
FDA to issue guidance to clarify the legality of using journal articles for
promoting off-label indications.
In the past decade, the FDA's legal authority to regulate off-label
promotional practices has been challenged by the industry on First Amendment
grounds despite the 1997 law. Since the late 1990s, the Washington Legal
Foundation has brought a series of cases against the FDA's attempt to restrict
off-label marketing. The court rulings on these cases did set limits on the
agency's authority on the basis of freedom of speech, but the actual
boundaries of the agency's power remain undefined.
Meanwhile, federal prosecutors have filed a number of criminal and civil
cases against drug companies on charges of illegally promoting off-label
claims. For example, in 2005 Eli Lilly pleaded guilty and paid $36 million in
fines for promoting their drug raloxifene (Evista) for preventing breast
cancer, which was not an approved indication at that time but had been
described for that purpose in published studies. In 2007 Bristol-Myers Squibb
agreed to pay hundreds of millions of dollars in fines to settle cases,
brought by the Justice Department, that alleged it illegally promoted its
atypical antipsychotic drug aripiprazole (Abilify) for unapproved
The draft guidance outlines some general principles for the types of
reprints, articles, and reference publications that are allowed distribution.
For example, journals should "be published by an organization that has
an editorial board that uses experts who have demonstrated expertise in the
subject.. .and who are independent.. .to review and objectively select,
reject, or provide comments about proposed articles...." The journal
articles should be peer reviewed, not special supplements, and not funded by
one or more of the manufacturers of the product cited in the article.
The FDA draft guidance is posted at<www.fda.gov/oc/op/goodreprint.html>.▪