Friday, March 1, 2013

An FDA Seal Of Approval To Prevent Shortages?

By Ed Silverman
As concerns persist over prescription drug shortages, the FDA is looking for ways to perform a tricky balancing act – maintain a commitment to enforcement while encouraging manufacturing quality so shortages can be avoided. The problem, in particular, has involved sterile injectable medicines, since the production process can be vulnerable to contamination (see this). And remediation, of course, can lead to production slowdowns and shutdowns.
The shortages, as you may recall, have reverberated in different ways. Several US Senators say pricing by group purchasing organizations is to blame. Shortages have fed greater reliance on compound pharmacies, one of which caused the fungal meningitis outbreak. Cancer patients have been dying sooner. And the FDA, meanwhile, has been criticized for being overzealous (read herehere and here).
But the FDA believes it has identified a fundamental problem: the marketplace does not really recognize or reward quality. The folks who purchase injectables may discount quality issues and focus more on price, Janet Woodcock, who heads the FDA Center for Drug Evaluation Research and Marta Wosinka, director of economics staff at CDER, write in the latest issue of Clinical Pharmacology & Therapeutics.
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