Zane Memeger, the U.S Attorney for the Eastern district of Pennsylvania, has proclaimed that an appeals court[PS1] decision last year to overturn sales rep Alfred Caronia’s conviction for off-label promotion will not affect prosecutions in drug and healthcare cases in his district, at least for now.
Speculation has been rife following the Court of Appeals for the Second Circuit in Manhattan’s unexpected decision to overturn Caronia’s conviction, based on the ruling that his promotion of off-label uses for narcolepsy med Xyrem was counted as free speech under the First Amendment. Since then evidence has emerged that the FDA may simply change tactics and focus less on the speech act of the rep and more on the intention towards “misbranding” of the drug that this speech implies. Despite the Second Circuit court’s decision to vacate Caronia’s conviction, it was suggested in the court’s opinion that any statement from the sales rep about a use not included in the drug’s labelling could be construed as an illegal act of misbranding. The Philadelphia Enquirer reports Memeger as saying that his prosecutors will continue their focus on finding evidence of misbranding, and of “lying” by companies and their reps. Memeger stated that “there is no right of a company or individual to make false and misleading statements about the use of a drug. I don’t see a difference in prosecuting our cases as vigorously as we have.”
There has so far been no attempt by either the Justice Department or the Department for Health and Human Services (which oversees the FDA) to challenge the Second Circuit court’s decision on Caronia’s case (see here for back story). This may be a tactical move to keep the case out of the Supreme Court where a ruling could have wider implications, as at the moment the decision only affects the states of New York, Connecticut and Vermont. As Memeger explains, “The Second Circuit decision is not binding for other areas, but it can be relied upon for guidance.”
Was there ever any hope that off-label promotion would become legal in the U.S? Perhaps some of our readers were dismissive of the hype around this question from the beginning. In court Alfred Caronia argued successfully that conversations about off-label uses take place perfectly legally everyday between physicians and their patients, and that the rep shouldn’t be penalised for joining in on these conversations. Now it seems that this argument is looking less and less effective against a resurgent and determined FDA.
Source found here