Tag: first-amendment and off-label

Has the FDA Abandoned Its Off-Label Promotion Ban?

On Tuesday, the FDA entered into a settlement agreement in Amarin Pharma v. U.S. Food & Drug Administration, allowing Amarin to promote a prescription drug for off-label use, so long as its promotion is truthful and non-misleading. The Amarin Settlement seems to be an abandonment by the federal government of protecting the public from off-label prescriptions.  But these settlement were just the cost of doing business for the drug companies, while they continue rake in huge profits from the continued off-label prescribing of drugs, which does not diminish after the settlements. Of course, anything that is false or misleading is still grounds for charges, but that is a far harder case to make. I think the ban against off-label promotion is dead for all practical purposes.  

‚ÄúDrugs, Greed and a Dead Boy‚ÄĚ

New York Times columnist, Nicholas Kristof, relates the story of Andrew Francesco, a boy who began taking Ritalin at age five and died from complications with Seroquel when he was fifteen. His father, a former pharmaceutical industry executive, reveals the industry‚Äôs greed in his memoir ‚ÄúOvermedicated and Undertreated.‚ÄĚ Now the industry is pushing for a first-amendment right to market its drugs for off-label uses.