Merck’s Saphris Gets FDA Letter After Taking Informant To Lunch
This article was originally published in The Pink Sheet Daily
A complaint to the “Bad Ad” program that a speaker had promoted an unapproved use for Merck’s atypical antipsychotic Saphris leads FDA’s Office of Prescription Drug Promotion to issue a “notice of violation” letter.
You may also be interested in...
In its first year of operation, FDA's "Bad Ad" program succeeded in more than tripling the number of complaints the agency receives about deceptive drug advertising, and now the agency is assessing how best to expand upon the success of the initiative.
Forest Admits To Knowingly Obstructing FDA Inspection In Guilty Pleas On Levothroid, Celexa Marketing
Forest Pharmaceuticals reached a $313 million settlement with the Department of Justice to resolve criminal charges of obstructing an FDA inspection and distributing a misbranded drug and civil False Claims Act allegations.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.