Panel's report blames drug shortages on FDA regulation

A new report from a Republican-led House oversight committee (PDF) has found that regulatory activity by the Food and Drug Administration at drug-company facilities has led to a shortage of generic, injectable medications.

According to the findings from the House Committee on Oversight and Government Reform, the FDA's regulatory activity has shut down about 30% of total manufacturing capacity at four of the nation's largest producers of injectible medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals and Teva Pharmaceuticals. Meanwhile, of the 219 drugs listed on the American Society of Health System Pharmacists shortage list as of February 2012, at least 128 of them were produced by at least one facility undergoing remediation.

“Among shuttered manufacturing lines that occurred over the two previous years, the Committee’s review did not find any instances where the shutdown was associated with reports of drugs harming customers,” Rep. Darrell Issa (R-Calif.), chairman of the committee, said in an announcement about the report.

Erica Jefferson, an FDA spokeswoman, said in an e-mail that preventing drug shortages is a priority for the agency, which has prevented 50 shortages in 2012 because of early notification from manufacturers. “We recognize that the problem of drug shortages is complex and stems from an interconnected series of factors,” the FDA statement said. “However, manufacturing and quality problems continue to account for the majority of current shortages,” it continued. “These issues have mainly occurred with sterile, injectable drugs.”