FDA Enforcement of Off-Label Promotion Hindered by Website, Lawsuit

FDA enforcement of drug companies’ use of off-label promotion is being made more difficult by Amarin’s successful lawsuit against the agency and by a government website, ClinicalTrials.gov, a law professor says.

Launched in 2000, the government website established a vehicle to get off-label information out to patients and physicians, says Ralph Hall, of the University of Minnesota Law School.

“If providing this information is against public policy, that public policy has to be consistent,” Hall said. “Why are we putting off-label information out there in ClinicalTrials.gov for the express purpose of informing patients about off-label uses” and then telling drug companies they can’t discuss off-label uses with doctors, he says. “From a legal perspective, I think it’s a problem for the government.”  

Hall argued the implications of a New York federal court’s free-speech ruling in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al. with Timothy Mackey, director of the Global Health Policy Institute, during an FDAnews-sponsored debate.

Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York held that Amarin has a constitutional right to promote its fish oil drug Vascepa (icosapent ethyl) for off-label uses so long as the language is truthful and nonmisleading. The company has been telling physicians that the drug can help lower triglyceride levels in patients who are already taking statins.

More recently, Amarin asked Engelmayer to halt further litigation until Oct. 30 while the company and the FDA discuss potential settlement options.

Mackey downplayed the relevance of ClinicalTrials.gov in the off-label debate. While the website allows public access to such information, its main purpose is to provide greater transparency into ongoing drug research, he says.

Hall expects the FDA will look for other cases of off-label promotion, but predicts the government won’t have any easy time defending its position against drugmakers. The Vascepa case set up nicely for Amarin and created major problems for the FDA since the promotion was aimed at physicians and not at patients, he says. — John Bechtel