|FDA Enforcement of Off-Label Promotion Hindered by Website, Lawsuit|
|By FDAnews Drug Daily Bulletin|
|Tuesday, 15 September 2015 01:28|
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.