House report blames FDA actions for drug shortages

There is no argument from the FDA that manufacturing shutdowns tied to quality issues have been the main reason behind drug shortages in the U.S. So, when a U.S. House report came out saying as much, the agency agreed.

"We recognize that the problem of drug shortages is complex and stems from an interconnected series of factors," FDA spokeswoman Erica Jefferson, told Reuters. "However, manufacturing and quality problems continue to account for the majority of current shortages."

Shortages of drugs have jumped to 250 last year, from 56 in 2006, Reuters reports. The report says that is because the four largest generic drugmakers--Hospira ($HSP), Teva Pharmaceuticals ($TEVA), Sandoz, the generics division of Novartis ($NVS) and Boehringer Ingelheim's Bedford Laboratories--lost 30% of their capacity when the FDA expected them to upgrade their manufacturing. Of the 219 drugs currently in shortage, the report says 128 were produced by those facilities. Do the math and that means the shutdowns account for 58% of the drugs on the shortage list. And the FDA can point to far fewer shortages this year since it has been asking manufacturers to give it earlier warning of anything that might lead to one.

Erin Fox, of the University of Utah's drug information service, which tracks shortages, says there is no doubt the FDA has been stricter on manufacturing quality since about 2008, when 80 patients died after taking a blood thinner tainted by Chinese heparin. That was an event that also landed the agency in hot water with House subcommittees. She tells Reuters she is surprised the report lays the blame at the feet of the FDA without even mentioning the severity of quality problems it found. "Certainly, FDA has very likely made it hard for these companies to comply," she said. "But on the other hand, FDA is finding scary things. I wouldn't want my loved ones to have drugs that are contaminated with bacteria injected into their veins, or with glass shards."

The report is sure to be considered political coming from a committee of the Republican-controlled House and because it's chairman, Rep. Darrell Issa (R-CA), said the shortages coincide with President Obama's appointment of FDA Commissioner Margaret Hamburg. Still, it does raise an interesting question about how much forethought the agency gave to possible shortages before pressuring the biggest genericsmakers to close down production lines for essential drugs.

- read the Reuters story
- here's the report (PDF)

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