Second Circuit Okays Off-Label Promotion
By Sydney Abbott, JD, Policy Coordinator, ACCC
The long-held understanding that a pharmaceutical representative may not discuss any off-label use of an FDA-approved drug with a provider has been turned on its head by a federal appellate court in Manhattan. The controversial decision to allow pharmaceutical sales representatives to promote drugs for off-label use was recently determined in a 2-1 decision by a three-judge panel in the Court of Appeals for the Second Circuit, in United States v. Caronia. This ruling could have specific ramifications for ACCC members.
The way sales representatives may communicate with providers could change in the future. The federal appellate court ruling overturned a lower court’s decision on the basis of free speech. Leaning on recent precedent calling pharmaceutical use of prescription data for marketing purposes free speech, the court determined that pharmaceutical representatives are exercising their right to free speech when promoting the off-label use of an FDA (Food and Drug Administration) approved drug, so long as the use is supported by compendia.
This ruling is a complete reversal of the way FDA views the issue. Therefore, the government will likely appeal the ruling to the U.S. Supreme Court. If the ruling is upheld, the Supreme Court could address the slippery slope issue of defining parameters for promotion. What constitutes compendia? Ultimately, this decision could be a game-changer in the way pharmaceutical representatives interact with providers. And, it could have far-reaching impact beyond drugs, possibly into anything the FDA has its hand in, like medical devices, diet aids, or tobacco.
Most importantly, though, know that no change in your interaction with pharmaceutical representatives is likely in the near-term. First, the appellate court’s decision is limited to the Second Circuit’s jurisdiction – New York, Connecticut, and Vermont. In every other state it is still the law that no discussion of off-label uses is permitted by drug representatives. And, even with this decision, companies are unlikely to change their policies before a final decision on the matter is made by the U.S. Supreme Court.
For the full decision, please see United States v. Caronia.