FDA's ability to introduce sponsor dissemination of off-label reprints as evidence in enforcement action litigation may be the next item open for constitutional questioning, following the Feb. 11 dismissal of Washington Legal Foundation v. Henney by the Washington D.C. appeals court.

"A manufacturer...may still argue that the FDA's use of a manufacturer's promotion of off-label uses as evidence in a particular enforcement action violates the First Amendment," Judge Laurence Silberman, author of the opinion, wrote.

The appellate court decision permits FDA to present off-label disseminations as evidence of intent in enforcement actions. "The FDA retains the prerogative to use both types of arguably promotional conduct," reprint dissemination and involvement in continuing medical education content, "as evidence in a misbranding or 'intended use' enforcement action," the court determined, while at the same time inviting industry and WLF to consider First Amendment issues on that front.

Manufacturers could potentially invoke First Amendment defense strategies when battling potential FDA enforcement actions.

WLF challenged the constitutionality of FDA guidances regulating off-label dissemination, continuing medical education and the off-label provision of the FDA Modernization Act. In a July ruling, Washington D.C. district court Judge Royce Lamberth threw out the restrictions. The ruling concluded the FDAMA provisions were unwarranted limitations on free speech and enjoined FDA from prohibiting dissemination of off-label reprints or proscribing manufacturers from suggesting content to CME program providers. FDA appealed the decision.

The appellate court dismissed the FDA's appeal and vacated the district court injunctions "insofar as they declare the [FDA Modernization Act] and [continuing medical education] guidance unconstitutional."

At Jan. 10 oral arguments, FDA's reinterpretation of the enforcement authority embedded in FDAMA enabled the agency to avoid constitutional scrutiny from the higher court. Off-label promotions would be prohibited by FDA only if they expressly violate an agreement struck between the agency and a firm under FDAMA, the agency argued in court.

FDA essentially characterized the FDAMA provisions as a "safe harbor" to ensure that the off-label communications would not be used against manufacturers in enforcement actions against misbranding or introduction of an unapproved drug into interstate commerce. The agency conceded at the courtroom podium that neither FDAMA nor the guidance independently authorized FDA to prohibit speech, and thus successfully avoided First Amendment evaluation of the policies.

"The stage appeared to be set for us to consider a difficult constitutional question of considerable practical importance. As a result of the government's clarification at oral argument, the dispute between the parties has disappeared before our eyes," the court said, explaining the case dismissal.

Though WLF has been hailing the court's decision as a "victory," the merits of the predominant issue the advocacy group fought for - protecting the first amendment rights of its constituency to receive scientific information, and companies' to disseminate it - went unaddressed by the court.

WLF interprets the court decision as preserving the parts of the district court injunction applicable to off-label reprints and medical texts.

The foundation supports its interpretation with a court decision footnote stating "we emphasize that the FDA unequivocally stipulated in its briefs and at oral argument that the Act and its implementing regulations supersede, rather than supplement, the enduring materials guidances. And even if they were not superseded, they would be unenforceable, since the FDA does not challenge on appeal the district court's decision and the injunction insofar as they pertain to enduring materials."

WLF's interpretation could potentially be applied by companies defending themselves from FDA enforcement to prevent the agency from admitting the proscribed off-label activities as evidence of intent in enforcement cases.

WLF will be "keeping a close eye on FDA; the very first time FDA so much as suggests that a manufacturer could be sanctioned for distributing truthful information of the type covered by the injunction, we will be back in district court seeking to have FDA held in contempt," WLF said in a Feb. 11 "Legislation Update" describing the court decision.

WLF Appeals Court Decision Leaves Free Speech Question Open

More from Archive

More from Pink Sheet