FDA violated the terms of a Washington Legal Foundation v. Henney federal appeals court decision when it cited New Star Lasers for dissemination of peer-reviewed articles to doctors, WLF argues in a May 23 citizen petition to the agency.

In an untitled letter dated Nov. 27, 2000, FDA reprimanded New Star for distributing a journal reprint with an attached label stating "Wrinkle Treatment Indication Pending FDA Clearance." New Star markets the CoolTouch line of non-ablative lasers used in dermatology procedures.

"We object to the use of this language on your journal reprints because your device has not been cleared by the agency for wrinkle treatment," the agency stated. "Dissemination of journal articles with this kind of language is considered by the agency to be promotion of your laser for an uncleared use."

FDA's citation of New Star disregards the history of the WLF v. Henney rulings, WLF argues, noting that "FDA makes no allegation [in the untitled letter] that any information contained in the article is in any way false or misleading."

In a July 1999 ruling in the WLF case, D.C. District Court Judge Royce Lamberth enjoined FDA from prohibiting the dissemination of off-label reprints or prohibiting manufacturers from suggesting content to CME program providers.

On the basis of FDA's oral arguments, however, the D.C. Circuit Court of Appeals overturned the injunctions "insofar as they declare the [FDA Modernization Act] and [continuing medical education] guidance unconstitutional." FDA argued before the court that the FDAMA provisions on off-label dissemination serve as a "safe harbor" from prosecution for companies, but do not in themselves confer enforcement authority.

Following the decision, the agency stated in a March 16, 2000 Federal Register notice that it may still use off-label reprints as evidence in a misbranding or "intended use" enforcement action brought under the FD&C Act.

After FDA issued the notice "and indicated that it no longer felt bound to comply with the district court's rulings with respect to enduring materials, many manufacturers were understandably reluctant to continue to disseminate enduring material that discussed off-label uses of their products," WLF states.

The New Star letter is representative of "FDA's disregard of the district court's first amendment rulings," which has "found its way into enforcement letters sent by FDA directly to manufacturers," WLF maintains.

The letter implies that dissemination of off-label information, "under circumstances not described in Section 401 of FDAMA, violates FDA regulations," WLF argues. "Given the limiting construction of Section 401 to which FDA has committed itself, the letter's implication is absolutely false."

The group is now petitioning FDA to withdraw the March 16 notice. "By raising the threat of enforcement action against manufacturers that exercise their free-speech rights, the notice violates the first amendment rights of manufacturers who wish to speak in a non-misleading manner about off-label uses of their products."

In place of the notice, WLF wants FDA to issue a policy statement that indicates "its willingness to abide by the district court's decision."

Lamberth denied a WLF petition filed April 6, 2000 to revoke the notice, stating that his injunction had been vacated by the appellate court.

WLF indicated it might sue FDA again if it does not receive a favorable response to its most recent petition. "In the absence of FDA action to correct its violations, WLF will take appropriate legal action," the group states. FDA has 180 days to respond to citizen petitions.

FDA's retraction of the notice should indicate that FDA will not prohibit manufacturers from disseminating peer-reviewed journal articles or reference textbooks regardless of whether they include "significant or exclusive focus on unapproved uses for drugs or medical devices that are approved by FDA for other uses," WLF states. FDA should also indicate that manufacturers would not be restricted from providing support to CME activities.

WLF Files Citizen Petition With FDA To Clarify Off-Label Dissemination

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