FDA Seeks Regulatory Authority Over Compounding Pharmacies

November 13, 2012 — The U.S. Food and Drug Administration (FDA) is requesting greater authority to regulate compounding pharmacies, in the wake of a massive outbreak of fungal meningitis that has sickened 438 people and killed 32. Until now, compounding pharmacies have been loosely regulated between each state’s pharmacy board and the federal FDA. However, as details about the outbreak emerge, many are concernted that this regulatory system has been inadequate to prevent contaminated medicines from sickening vast numbers of people.

Compounding pharmacies are supposed to mix custom medications for specific patients (for example, turning a solid medication into a liquid for a patient who cannot swallow). In recent years, however, some pharmacies have begun mass-producing medications for large numbers of people without prescriptions.

New England Compounding Center (NECC) has been accused of mass-producing drugs without a license. Earlier this year, the Colorado Pharmacy Board complained about NECC violating their license, but the complaint was ignored by the Massachusetts Pharmacy Board. The director of the board was fired over that oversight. Despite the fact that there were more than a dozen complaints about sanitation and good manufacturing practices at NECC, the company continued to produce drugs.

The FDA initially tried to enforce its authority over NECC in 2002, after complaints surfaced about sanitation and manufacturing practices. The federal health inspectors wanted to shut down the pharmacy until they improved their practices. However, after NECC complained to the Massachusetts Pharmacy Board that the FDA was overstepping its authority, the FDA agreed with the Board that NECC was not subject to strict safety standards that the FDA imposes on drug manufacturers.

During the investigation, the FDA report also noted that Barry Cadden, the pharmacy’s owner and director, told FDA officials “that he was no longer willing to provide us with any additional records,” and “this FDA inspection could not proceed to any definitive resolution.” Mr. Cadden is scheduled to appear at a hearing before congressional lawmakers. He was subpoenaed after indicating he would not attend voluntarily. The director of the FDA, Margaret Hamburg, and the director of the Massachusetts Public Health Department is also scheduled to appear.

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