Dissemination of off-label journal reprints alone is "unlikely" to trigger enforcement action against a drug or medical device manufacturer, FDA says.

"FDA is unlikely to initiate an enforcement action where the only evidence of an unapproved intended use is the distribution of enduring materials or sponsorship of [continuing medical education]," the agency wrote Jan. 28 in response to a Washington Legal Foundation citizen petition.

Materials will be viewed in the context of other activities and used as a way to discern manufacturer intent, FDA notes.

In combination with "a pattern of other statements" or "multiple aspects of a promotional display," which support a conclusion that a manufacturer is promoting products for unapproved uses, journal reprints or CME sponsorship could be used as evidence supporting agency enforcement action, the agency cautions.

The materials would not be used in cases where manufacturers have complied with the "safe harbor" criteria in Sec. 401 of the FDA Modernization Act.

WLF's May 23 petition requested that FDA withdraw a March 16, 2000 Federal Register notice describing the Washington D.C. federal appellate court decision that ended litigation brought by WLF over FDA's reprint policy (¹ Also see "WLF Appeals Court Decision Leaves Free Speech Question Open" - Pink Sheet, 14 February, 2000., p. 3).

WLF asked that FDA issue a policy statement indicating "its willingness to abide by the district court's decision" because, WLF maintained, the notice infringes manufacturers' First Amendment rights (² [A#00630220007], p. 13).

"FDA declines to withdraw the Federal Register notice and to change its policy regarding the potential evidentiary use of reprint distribution or CME sponsorship in actions to enforce substantial violations of Sec. 301" of the FD&C Act, the agency said in its Jan. 28 response.

FDA maintains that the notice and agency policies are consistent with First Amendment law and previous court rulings on the matter. "That a manufacturer's expressions - direct or through the apparent adoptions of the words of others - may be used as evidence of its intent does not itself violate the First Amendment," the agency argues.

In comments submitted to FDA Nov. 8 in support of the WLF petition, the Coalition for Healthcare Communication requested that FDA replace the March 2000 notice with one describing a policy that would allow off-label dissemination accompanied by full disclosure of the source of the information and its unapproved status (³ Also see "FDA Off-Label Policy Should Allow Dissemination With Disclaimer – CHC" - Pink Sheet, 26 November, 2001., p. 10).

WLF also asked the agency to take steps to train enforcement personnel regarding the relevant First Amendment law and to issue additional guidance on the agency's enforcement policy regarding manufacturer sponsorship of CME dealing with unapproved uses of medical products.

The agency "is working to ensure that its personnel understand that FDCA does not contain an independent prohibition against the dissemination of truthful, non-misleading reprints of articles or textbook excerpts regarding unapproved new uses of approved medical products or against manufacturer sponsorship of CME at which such uses will be discussed."

Under a new FDA policy, Division of Drug Marketing, Advertising & Communications warning and untitled letters will require prior approval from the Office of the Chief Counsel before issuance (⁴ Also see "FDA Warning/“Untitled” Letters Will Be Reviewed By Chief Counsel" - Pink Sheet, 17 December, 2001., p. 30).

FDA Chief Counsel Daniel Troy was one of WLF's litigators against FDA. He is recused from involvement in issues involving former clients for one year after joining the agency.

FDA will not issue additional guidance with regard to CME in the near future, the agency said. "Given the case-specific nature of the determination whether or not to bring a misbranding action, and if so, what evidence to introduce, FDA has no current plan to expand or alter its CME guidance."

While the language in the decision indicates that FDA may exercise restraint in its enforcement actions in response to off-label reprints, the agency also reserves the right to take action should it deem it necessary.

WLF expresses "disappointment" with the decision, maintaining that it does little to clear up manufacturer uncertainty over FDA's enforcement practices. The group is considering renewed litigation.

FDA Affirms Off-Label Dissemination Policy In Denial of WLF Petition

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