The Op-Ed: A Slew Of Off-Label Promotion Is Unlikely

By Ed Silverman // December 6th, 2012 // 12:09 pm

Earlier this week, a federal appeals court panel overturned the conviction of a former sales rep for allegedly encouraging doctors to prescribe a drug on an off-label basis, ruling that his conviction violated his First Amendment rights. The ruling may not be the final word on the issue, but a vigorous debate – including considerable speculation – has since ensued. So what happens next? Will this reach the US Supreme Court? Is all off-label promotion now protected free speech? And will consumers see a barrage of off-label advertising. Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, looks at his crystal ball and finds…

The split-decision by a three judge panel of the US Second Circuit Court of Appeals in United States v. Caronia (see back story and ruling here) has pharmaceutical and First Amendment lawyers all abuzz. In fact, there has already been at least one law firm webinar on the subject a mere few days after the decision was rendered.

Just to recap, over a vigorous dissent, a two-judge majority held that, in order to avoid a First Amendment violation, the Federal Food, Drug, and Cosmetic Act should be construed as not prohibiting mere off-label promotion of an FDA-approved drug that is neither false or misleading.

In concluding that the defendant’s conviction should therefore be overturned, the majority relied to a considerable extent on the U.S. Supreme Court’s decision in Sorrell v. IMS Health (back story with ruling).

In that case, the court concluded that “(s)peech in aid of pharmaceutical marketing… is a form of expression protected by the… First Amendment” and, on First Amendment grounds, overturned a Vermont statute that prohibited the use of physician-identifiable prescribing data in detailing to doctors.

The dissent in the Caronia case by Judge Debra Ann Livingston focused to a considerable extent on the implications of the majority decision on a bedrock principle of food and drug law – “intended use” – and on the historical understanding that each intended use of a new drug must be separately approved by the FDA.

Otherwise, there would be little incentive for companies to seek approval of new drug application, supported by “substantial evidence” as that term is defined in the Food, Drug & Cosmetic Act, for an indication as yet unapproved by the agency.

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