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Off-Label Drug Information Still a Problem
e-Solutions from RBH Associates
03/27/2002

The Food and Drug Administration (FDA) refused to change its policy regarding the "potential evidentiary use" of off-label drug information, as distributed by manufacturers of journal reprints or through sponsorship of CME events. The FDA discussed its position in a 10-page letter dated January 28 sent in response to a Washington Legal Foundation (WLF) petition filed May 23, 2001 asking for a change in policy.

The WLF called the FDA position, which was outlined in a Federal Register notice, "a thinly-veiled threat to bring enforcement action against manufacturers who disseminate medical texts or peer-reviewed journal articles that discuss off-label use of approved products.

"FDA refusal to provide guidance in this area means that much speech protected by the First Amendment is being chilled," according to a WLF statement."Dissemination of enduring materials or support of CME as the only evidence of unapproved use is unlikely to result in enforcement action," the agency said in response to the WLF petition. "These materials will be viewed within the context of other activities as a way to determine manufacturer intent." The FDA prohibits promotion of unapproved uses. The issue is dissemination of truthful, published educational materials that provide expert information to healthcare practitioners. The FDA said that whether or not it brings a misbranding action will be determined on a case-by-case basis. It will enforce "substantial violations" of the Federal Food, Drug, and Cosmetic Act, the agency said.

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