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

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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.

 

Read more at FDANews.com




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