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2nd Circuit decision throws FDA’s drug misbranding cases into question

In U.S. v. Caronia, the court vacated the conviction of a pharmaceutical sales rep for off-label but truthful promotion, contending it violated his First Amendment rights

The Food and Drug Administration (FDA) has been aggressive in pursuing drug companies and their sales personnel that promoted drugs for off-label uses, or uses that the FDA has not approved.

Both criminal and civil False Claims Act cases have paid off for the government, often lucratively. The record $3 billion penalty that GlaxoSmithKline agreed to pay in July 2012—the largest health care fraud settlement in U.S. history—came in a case that centered on the government’s claims that the drug company promoted several drugs for off-label uses, rendering the products misbranded and thus illegal under the Food, Drug and Cosmetic Act (FDCA). Just months before that, Abbott Laboratories Inc. paid $1.5 billion to resolve criminal and civil charges related to off-label promotion.

Free Speech Finding

Caronia was an employee of Orphan Medical Inc. (now Jazz Pharmaceuticals) when a doctor recorded him promoting the drug Xyrem for uses unapproved by the FDA. After a trial at the U.S. District Court for the Eastern District of New York, a jury in 2008 found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commerce.

Associate Editor

Melissa Maleske

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