December 26, 2012 10:54:06 AM by
On December 3, a three-judge panel of the U.S. Court of Appeals for the Second Circuit ruled in favor of Al Caronia, a pharmaceutical salesman who had been convicted of violating the Federal Food, Drug and Cosmetic Act by pitching the off-label uses of a narcolepsy drug to doctors at conferences throughout the country. Declaring that the Department of Justice’s overly broad interpretation of the law violated Caronia’s free speech rights, the Court vindicated a practice that has become commonplace among physicians.
Doctors such as Peter Gleason, Caronia’s former codefendant, learn through their experiences with patients that many drugs turn out to be effective treatments for ailments other than those for which the FDA has granted official approval. And physicians have a well-established right to prescribe any drug for any use they see fit and to share their insights about effective treatments with other doctors. So it came as quite a surprise to Dr. Gleason when he was arrested by a half-dozen federal agents one day in 2006 and sent down the rabbit hole of the federal criminal justice system for allegedly conspiring to mislead his fellow physicians. I discussed Dr. Gleason’s unjust prosecution in my book Three Felonies a Day: How the Feds Target the Innocent (Encounter Books, 2009). My latest piece for the Wall Street Journal serves as a postscript for that discussion, explaining how the Second Circuit’s ruling vindicated Dr. Gleason’s belief that he had never engaged in any improper activity – vindication that, tragically, came too late.
You can find the piece on the Journal's website.