Regulatory Focus™ > News Articles > FDA: Drug Shortages Likely to be Persistent For Years

FDA: Drug Shortages Likely to be Persistent For Years

Posted 19 March 2012 | By Alexander Gaffney, RAC 

An article in the 17 March edition of the UK medical journal The Lancet argues drug shortages in the US are persistent and unlikely to abate in the next few years, citing sources within the US Food and Drug Administration.

A number of factors are contributing to the drug shortages, says Lancet correspondent Sharmila Devi, including manufacturing consolidation, quality deficiencies, low price margins and a lack of investment in manufacturing capacity or upgrades.

Devi quotes Sandra Kweder, deputy director of FDA's Office of New Drugs, as saying, "it will be several years before companies building new plants get them up and running."

"We don't have any expectation the issue will be resolved soon," added Kweder.

Kweder said quality-related problems were behind the majority of drug shortages, and FDA is working with manufacturers to address these deficiencies as fast as they can.

Continued Kweder: "There's no requirement for the FDA to do any of this, nothing in the statutes or public health service act but we're in a unique position to have information and context to solve the problems."

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The Lancet - US drug shortages could continue for years

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