Tag: off-label marketing
āLawmakers Accuse HHS of Delaying FDA Guidelines for Off-Label Marketingā
Ed Silverman reports for STATās Pharmalot that high-ranking congressmen are accusing the Department of Health and Human Services of deliberately delaying new guidelines on...
Has the FDA Abandoned Its Off-Label Promotion Ban?
On Tuesday,Ā the FDA entered intoĀ a settlement agreement inĀ Amarin Pharma v. U.S. Food & Drug Administration, allowing AmarinĀ to promoteĀ a prescription drug for off-label use, so long as its promotion is truthful and non-misleading. TheĀ Amarin Settlement seems to be an abandonment by the federal government of protecting the public from off-label prescriptions. Ā 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 promotionĀ is dead for all practical purposes. Ā
