FDA blames quality issues for most shortages; others blame FDA

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The FDA has thrown down an answer to last week's charge that bumped-up oversight--aka over-regulation--is to blame for record-breaking shortages of key drugs. Quality problems at drugmakers are causing the lion's share of the shortages, FDA's Valerie Jensen, associate director of the Center for Drug Evaluation and Research's shortage program, tells HealthDay.

More than half of the 2010 shortages were caused by quality issues, including sterility problems and contamination, Jensen said. "In 2011, we're seeing the same trend, a very large number of quality product issues leading to shortages," she said.

Anyone who's been keeping tabs on this year's drug recalls knows that many injectables makers have been plagued by "floating particles" and other sorts of contamination. Glass flakes have been found repeatedly in injectables vials, too. For instance, American Regent and Luitpold Pharmaceuticals, a unit of Daiichi Sankyo, have pulled multiple products tainted by silicon particles and glass bits. Both companies have injectables that have run short.

Last week, Watson Pharmaceuticals CEO Paul Bisaro, who's chairman of the Generic Pharmaceuticals Association, told the Financial Times that FDA inspections have caused shortages. He cited the shortage of the anesthetic propofol, which is only made by two suppliers, now that Teva has shut down its propofol plant after an FDA inspection. The inspectors had found microbial contamination.

The drug-shortage problem isn't a simple issue and it can't be traced to a single cause. To be sure, FDA inspections can trigger their share of bureaucratic nonsense. But plant inspections are certainly easier when FDA can find nothing to complain about. And who can blame the agency for stepping up oversight at a time of repeated recalls--and increasing pressure from lawmakers to keep the drug supply safe?

- get the piece from HealthDay
- see the Financial Times story
- read the Medscape article

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