Dissemination of journal reprints representing off-label use of a device or drug will not by themselves trigger FDA enforcement action against a manufacturer, according to the agency.

"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 (CME), the agency states in a Jan. 28 decision.

In the letter, the agency denies the Washington Legal Foundation's May 2001 citizen petition to distribute "non-misleading" off-label information materials.

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

For example, enduring materials and CME sponsorship may be used as evidence supporting agency enforcement action if the manufacturer is engaged in other behavior suggesting intentional promotion of products for unapproved uses. The materials would not count as evidence in cases where firms had complied with the "safe harbor" criteria in Sec. 401 of the FDA Modernization Act of 1997.

WLF's petition requested that FDA withdraw its ¹ March 16, 2000 Federal Register notice describing the agency's interpretation of the 1999 Washington Legal Foundation v. Henney decision.

In the petition, WLF maintained that the current notice infringes manufacturers' First Amendment rights. The Coalition for Healthcare Communications (CHC), which includes nine communication industry organizations, filed comments supporting the petition in November (² Also see "Disclaimers Do Not Remedy Content Violations – FDA Warning Letter" - Medtech Insight, 10 December, 2001., p. 25).

The warning letter to New Star Lasers, Inc. cited by WLF in its petition and the AstraZeneca warning letter referenced in the supporting statement submitted by the CHC both represent cases where the enduring materials were coupled with other violations, FDA maintains.

"Although [the New Star Lasers] letter addresses the distribution of reprints, it also refers to a pattern of other statements, on the manufacturer's website, indicating an intent that the product in question be used for unapproved purposes," according to the agency.

The AstraZeneca letter also illustrates when FDA will take enforcement action. The letter "addresses multiple aspects of a promotional display that indicate the manufacturer's intent that several of its products be used for unapproved uses."

"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 section 301" of the Food Drug & Cosmetic Act, the agency concludes in its response to WLF.

FDA argues that the notice and agency policies are consistent with the First Amendment 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," FDA states.

WLF also asked the agency to take steps to train enforcement personnel with respect to First Amendment safeguards. The group sought additional guidance on FDA's enforcement policy regarding manufacturer sponsorship of CME programs focused on unapproved uses of medical products.

The agency says it "is working to ensure that its personnel understand that the FD&C Act 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."

However, FDA will not issue additional guidance with regard to CME in the near future. "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."

Although FDA has decided to retain the language in its Federal Register notice, the recent decision to route all agency warning letters though the Office of the Chief Counsel could result in a more restrained enforcement policy going forward (³ Also see "Allen, Azar & Troy: FDA Legal Partners Streamline Enforcement Activity" - Medtech Insight, 17 December, 2001., p. 3). The January FDA letter of denial explicitly notes that all agency warning and "untitled" letters will be "reviewed for legal sufficiency, including adherence to the First Amendment."

While the language in the decision indicates that FDA may be more selective in its enforcement actions in responding to off-label reprint decisions, it also makes clear that the agency reserves the right to take necessary action.

WLF expressed disappointment with the decision, maintaining it does little to clear up manufacturer uncertainty over FDA's enforcement practices.

FDA's choice to retain enforcement discretion regarding off-label reprint dissemination is an affront to free speech, according to the group. Litigation is among the options WLF says it is considering.

Separately in January, FDA partially granted a WLF petition requesting the agency revoke invalid regs. "If a court has determined an agency regulation to be invalid and FDA has decided not to appeal," then the agency will remove the regulation, according to the Jan. 8 decision.

FDA is in the process of reviewing "past litigation and agency regulations to identify whether any court decisions have called into question an existing or pending regulation or guidance document," FDA said.

In addition, FDA "invites" others to "bring such regulations to [its] attention so [it] may determine whether they need to be removed or modified."

However, the agency takes issue with WLF's assertion that a delay in revoking an invalid rule is never justified, except in cases where the court ruling has been stayed.

"There are a number of legitimate reasons why an agency may under certain circumstances decline to apply the holding of one court decision when enforcing its statutes and regulations against parties not affected by the court's judgement," FDA asserts. FDA may wait for a Supreme Court ruling in certain cases before deciding to revoke a reg.

"The agency can foresee a court of appeals deciding a case while similar cases are pending elsewhere" and therefore declines granting WLF's request in its entirety, FDA concludes.

FDA Denies WLF Petition To Allow Dissemination Of Off-Label Information

More from Archive

More from Medtech Insight