As the investigation into a fatal outbreak of fungal meningitis continues, the commissioner of the Food and Drug Administration proposed Friday that the agency gain new authority to regulate pharmacy compounding, including charging fees to fund an expanded safety framework.
In a blog post, FDA Commissioner Margaret Hamburg, MD, said that since the outbreak of fungal meningitis associated with a compounded medication, the FDA has inspected more than 30 facilities, but the agency has limited authorities to appropriately and efficiently oversee the growing industry.
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“Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting,” Hamburg wrote in her post.
The meningitis outbreak was sourced to an unsterilized steroid from the New England Compounding Center (NECC), a facility based in Framingham, Mass. As a result of federal and state health departments' investigation of contamination at the facility, NECC announced a recall of all its products and voluntarily shut down, FDA said. It later filed for bankruptcy protection.
Serious problems at compounding pharmacies continue to occur, Hamburg noted. Congress, she wrote, should pass legislation to establish minimum standards and help FDA oversee firms that are involved in widespread distribution of sterile compounded drug products. “FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations,” she wrote.
Compounding pharmacies could support the expanded oversight, she suggested. For example, they could pay to register their facilities or other fees, similar to the way pharmaceutical companies pay fees for FDA’s drug approval process under the Prescription Drug User Fee Act (PDUFA).
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