FDA can’t sue drug company for truthful off-label marketing

August 10, 2015

(Reuters) – The U.S. government made a fateful decision in January 2013 when it opted not to seek U.S. Supreme Court review of the 2nd U.S. Circuit Court of Appeals’ 2012 ruling in U.S. v. Caronia, which overturned the conviction of a pharmaceutical sales representative engaged in off-label marketing of a narcolepsy drug. The 2nd Circuit, in a split decision, held that as long as drug companies stick to truthful and accurate statements, off-label marketing is protected commercial speech under the First Amendment and Supreme Court precedent in Sorrell v. IMS Health. Commentary at the time called Caronia a landmark holding that might limit the Food and Drug Administration’s ability to police drug misbranding, but – perhaps fearing a loss at the Supreme Court – the Justice Department and the FDA portrayed the 2nd Circuit ruling as a narrow decision that wouldn’t affect enforcement.

That now seems to have been an overly optimistic depiction of Caronia.

On Friday, as my Reuters colleague Brendan Pierson reported, U.S. District Judge Paul Engelmayer of Manhattan ruled the FDA may not take action against the Irish pharma company Amarin for telling healthcare providers about off-label benefits of its fish-oil product Vascepa. Judge Engelmayer’s 71-page opinion, one of the first to analyze the scope of the 2nd Circuit’s Caronia precedent, rejected the FDA’s restrictive interpretation and held the ruling offers broad First Amendment protection to truthful statements about a drug’s off-label uses.

“The court’s considered and firm view is that, under Caronia, the FDA may not bring  an action based on truthful promotional speech alone, consistent with the First Amendment,” Judge Engelmayer wrote. “The 2nd Circuit’s thoroughgoing First Amendment analysis in Caronia  defeats the FDA’s attempt to marginalize the holding in that case as fact-bound.”

As the judge explained, the FDA tried to cope with Caronia fallout in draft guidance issued in 2014. The agency conceded that pharma companies may distribute scientific or medical articles reporting on off-label use of their products to healthcare professionals, but stated that if a sales representative told a physician the article confirmed the safety or efficacy of the drug for off-label uses, the FDA could use those comments in a misbranding action.

In April 2015, Amarin received a warning from the FDA that it could be subject to a misbranding action if it marketed Vascepa as a treatment for patients with high triglycerides who are already taking statins. The drug has already been approved for patients with exceedingly high triglyceride levels and has been determined to lower those levels safely for patients on statins as well. But an FDA advisory committee said it was not clear that lowering these patients’ triglyceride levels would reduce their risk of cardiovascular problems so the FDA declined to approve the new use of the drug and hinted that Amarin could be in trouble if it told doctors about the results of its clinical study.

Amarin sued, invoking its First Amendment right to provide doctors with accurate information about its drug, especially because the FDA is already permitting its competitors to market similar products to the same patients. In an attempt to end the case, the FDA proposed marketing language it said was acceptable, but Amarin rejected proposals it said would restrict its ability to answer doctors’ questions about its drug.

Judge Engelmayer said the dispute prompted an essential question about the 2nd Circuit’s Caronia precedent: Can the FDA bring an action for misbranding based only on “truthful and non-misleading speech promoting an off-label use of an approved drug?” The FDA said it could still sue under Caronia, as long as it has not approved the product for off-label use, because marketing statements can show the manufacturer’s intent to misbrand the drug.

Amarin, which is represented by Cahill Gordon & Reindel, said that was too cramped a reading of Caronia. After oral arguments last month on the company’s motion for a preliminary injunction, Engelmayer agreed.

“In light of the parties’ conflicting readings of Caronia and the FDA’s position that it may bring a misbranding action against a manufacturer based solely on truthful and non-misleading speech evincing the intent to promote an off-label use, the court has closely reviewed Caronia,” he wrote. “A fair reading of (Caronia) refutes the FDA’s view that the 2nd Circuit’s ruling was limited to the facts of Caronia’s particular case.”

If the FDA still wanted to prosecute drug companies whose marketing reps tell doctors the whole truth about off-label uses of their products, the judge suggested, it could have appealed Caronia. But it didn’t.

Caronia does not give drug companies carte blanche for off-label marketing, Judge Engelmayer noted. The FDA can still prosecute misbranding cases when marketing reps pass along misleading or untruthful information or when drug companies promote off-brand uses by illegal means.

But at least according to Judge Engelmayer, Caronia and the First Amendment protect companies that tell the truth.

For more of my posts, please go to WestlawNext Practitioner Insights

Follow me on Twitter

No comments so far

We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/