Wednesday, November 29, 2023

Tag: off-label marketing

“Lawmakers Accuse HHS of Delaying FDA Guidelines for Off-Label Marketing”

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Ed Silverman reports for STAT’s 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?

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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.