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FDA Seeks Regulatory Authority Over Compounding Pharmacies

November 13, 2012 — In the wake of a massive outbreak of fungal meningitis linked to contaminated medicines from a compounding pharmacy, federal lawmakers have scheduled two days of hearings to hear testimony from the FDA, the owner of the pharmacy, and others. The FDA is expected to request additional authority to inspect and regulate compounding pharmacies.

Until now, compounding pharmacies have been regulated in a gray area between 50 state pharmacy boards and the FDA. They are also subject to far less strict standards than drug manufacturers. Part of the reason for the relaxed oversight is that, traditionally, compounding pharmacies were only supposed to mix custom medications for individual patients (for example, removing an ingredient from a drug for a patient with a specific allergy). However, in recent years, some compounding pharmacies have begun mass-producing drugs, acting like mini drug manufacturing companies.

As this trend has emerged, state pharmacy boards have been inadequately prepared to regulate the pharmacies, and the FDA has been accused of overstepping its bounds when it has tried to enforce strict standards.

New England Compounding Center (NECC), the compounding pharmacy that distributed medications that have sickened more than 400 and killed 32 people, had been the source of dozens of complaints since it opened in 1998.

In 2002, the FDA received complaints that lots of methylprednisolone acetate from NECC had sickened two people with bacterial meningitis. Those same medications were later linked to the outbreak of fungal meningitis. The FDA attempted to investigate, but Barry Cadden, the owner and director of NECC, refused to cooperate with the FDA. According to the FDA report from the inspection, Mr. Cadden 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.”

After the FDA inspected NECC in 2002, they initially wanted NECC to cease operations until the pharmacy fixed sterility and manufacturing issues. However, NECC complained to the Massachusetts Pharmacy Board that the FDA was overstepping its bounds. The FDA relented and allowed the pharmacy to stay open.

In the upcoming days of congressional hearings, officials from the FDA, Mr. Cadden, and others will testify before lawmakers. Mr. Cadden was subpoenaed after indicating that he would not appear voluntarily. FDA Commissioner Margaret Hamburg and the Massachusetts Department of Public Health commissioner Lauren Smith are also scheduled to testify.

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