The Food and Drug Administration is moving to pull ProAmatine, a blood pressure medication that’s been available for 14 years and racked up a quarter billion in sales, because the manufacturer hasn’t submitted a follow-up study that proves the drug is effective.
The FDA sent a letter to Shire Laboratories Monday proposing it pull its drug from shelves and telling the company it can schedule a hearing to plead its case.
What’s odd, according to an AP report, is that the Government Accountability Office says the FDA has never threatened to pull a drug because of an unimpressive or nonexistent follow-up study. Of all such studies the FDA has requested since 1992, only 64 percent have been completed.
Either Shire has terrible luck or this could be the sign of some new FDA consumer protection vigilance.
FDA moves to withdraw unproven blood pressure drug [AP via Yahoo News]