FDA Won’t Appeal First Amendment Off-Label Ruling

The FDA announced on January 23, 2013, that the agency would not appeal the landmark federal circuit court Caronia decision that the First Amendment protects truthful speech about the off-label use of FDA-approved products.

Alfred Caronia was prosecuted and convicted of conspiring to introduce a misbranded drug into interstate commerce. He was caught on tape telling a physician that the drug had uses other than what was on the product’s label. The government had wired up a physician under unrelated Medicare fraud charges. That physician eventually committed suicide.

A dissenting judge 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.” The decision only applied in New York, Connecticut and Vermont, the states covered by the appeals court.

After Caronia’s victory, the FDA had to decide if the agency wanted to risk appealing the case and losing another round over free speech.

Dramatic Risks of Appeal

Tom Beimers, a former prosecutor in the Department of Justice and now in private practice at Faegre Baker Daniels LLP, told us that had the FDA pursued this case the agency would have risked “dramatically expanding the reach of what they can now plausibly argue is a narrow precedent with limited geographic and factual scope. For the same reasons this case lacked jury appeal—reliance on technically ‘truthful’ speech, absence of patient harm, and no ‘sweeteners’ such as lavish kickbacks—it is also a poor vehicle, from the government’s perspective, for broader judicial review of off-label prosecutions.”

During a recent Minnesota LifeScience Alley forum on the potential impact of the decision on the medical industry, Beimers told attendees that he would not have brought a case with these sets of facts to trial. At the same forum, Ralph Hall, a law professor at the University of Minnesota said it was unlikely that device or drug companies were lining up sales reps to test the FDA’s off-label promotion position and using the Caronia decision to have the ruling applied throughout the rest of the country. The risk of losing and being given the “death penalty” for participation in federal healthcare programs like Medicare, are too high for companies, he said.

However, said Hall, the right to free speech is not only to speak freely, but also to hear freely. Perhaps, he mused, physicians, with less to risk, would bring charges that they are being denied the right to hear truthful speech from medical product sales people.

FDA: “No Significant Effect”

In a statement, the agency said, “FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug-misbranding provisions of the Food, Drug and Cosmetic Act. The decision does not strike down any provision of the…act or its implementing regulations, nor does it find a conflict between the act’s misbranding provisions and the First Amendment or call into question the validity of the act’s drug approval framework.”