Promoting off-label use for legal purposes is protected by free speech.
At least if you are selling drugs, said the U.S. Court of Appeals in New York on December 3. The Court did not specifically address whether or not someone selling FDA approved or cleared devices is also protected by the First Amendment.
Alfred Caronia, a sales rep for Orphan Medical, Inc., was convicted in 2008 for promoting Xyrem, a narcolepsy drug, for an unapproved use. Just like devices, physicians are allowed to prescribe drugs off-label, but manufacturers are prohibited from promoting that off-label use.
“Government Cannot Prosecute”
“The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug, ” U.S. Circuit Judge Denny Chin said in a 2-1 decision. “The proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing.”
Huge Decision
What does this mean for medical devices?
Just substitute the word devices in place of pharmaceutical and device reps possess the same constitutional protected free speech that pharmaceutical reps enjoy, attorney Jim Beck of pedicle screw fame, told us.
This is a huge decision, said Beck, but it does not mean that device reps are free to go out and start promoting their devices off-label. This decision is only good for the Second Circuit and the FDA can still bring criminal prosecutions against reps. Beck said the sole basis for vacating the conviction was the government’s failure to prove that any of the alleged promotion was false. “We don’t need a bunch of sales reps going out and promoting off-label uses that aren’t true, ” said Beck. The Court’s decision left undecided as to who is required to make the “truth” case.
The FDA told us they do not comment on ongoing cases. AdvaMed and the Medical Device Manufacturers Association did not provide responses at the time of this writing. We’ll get their comments for a more in-depth feature story on the decision next week.
Questioning the Foundation of Regulation
Judge Debra Ann Livingston, writing the dissent in the 2-1 decision wrote that the decision may restrict off-label prosecutions in the future. “The majority calls into question the very foundations of our century-old system of drug regulation.”
That system “developed to protect consumers from misleading and unsubstantiated claims about drugs’ safety and efficacy, and the prohibition on off-label promotion by drug manufacturers is essential to maintaining the effectiveness of that system, ” Livingston said.
Impact on Devices
The impact of the decision can’t be fully understood yet. Beck noted the Court did not declare the law prohibiting off-label use as being unconstitutional, only that the FDA couldn’t criminally prosecute Caronia in this case because they didn’t prove the off-label claims were false. But the legal basis for the FDA’s justification for preventing companies and reps from making true claims about a device or drug is under serious attack.
“It all comes down to whether the FDA’s ban on truthful speech is a legitimate way, under the First Amendment, to pursue those interests, ” concluded Beck.
Beck says there may also be a product liability impact. “If this rationale is adopted – plaintiffs will no longer be able to assert off-label promotion, in and of itself, as something that’s tortious. Ever since New York Times v. Sullivan, tort litigation cannot be based on First-Amended protected conduct.”
