Regulatory Focus™ > News Articles > Government Report Blames Drug Shortages on FDA, Calls for Change in Warning Letter Policy

Government Report Blames Drug Shortages on FDA, Calls for Change in Warning Letter Policy

Posted 18 June 2012 | By

A new report released by the Chair of the House Oversight Committee, Representative Darrell Issa (R-CA), blames the US Food and Drug Administration (FDA) for an "unprecedented" series of dug shortages which has had a particularly pronounced effect on cancer patients.

In the report, FDA's Contribution to the Drug Shortage Crisis, Issa claims that while others have attributed the causes of the shortages to a "myriad of factors"-raw materials shortages, market concentration and increased demand among them-his investigation found FDA "largely sparked" the shortages through its regulatory activities and facility inspections.

Issa specifically cited FDA's inspections and subsequent warning letters to four pharmaceutical manufacturers as the cause behind a 30% drop in their manufacturing capacity at the same time, which in turn was a contributing factor in more than half of all drug shortages. "These simultaneous shutdowns diminish the ability of competitors to alleviate the shortages with increased production," Issa wrote.

This stands in opposition to earlier efforts by the agency before the tenure of FDA Commissioner Margaret Hamburg, claimed Issa. "Among shuttered manufacturing lines that occurred over the previous two years [prior to the arrival of Hamburg], the committee's review did not find any instances where the shutdown was associated with reports of drugs harming customers."

After Hamburg joined the agency, warning letters increased 42% during the first year and an additional 156% the subsequent year, said Issa. "In many cases, warning letters have resulted in companies agreeing to take manufacturing off-line to address FDA criticisms," the Congressman noted.

Rather than direct facilities to shutter lines while they are reconstituted, companies should be subject to the "close supervision of the FDA" while they make their facilities compliant, recommended Issa. This would be a "more appropriate response than actions that lead companies to shut down manufacturing lines," added Issa.

Read more:

FDA's Contribution to the Drug Shortage Crisis

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