Compound Fracture

Bills Will Not Fix FDA's Broken Oversight of Drug Compounding

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In September 2012, a 78-year old judge named Eddie Lovelace died in Nashville, Tennessee, from an apparent stroke. His death was later revealed to be the first in an unprecedented outbreak of fungal meningitis and joint infections associated with a contaminated drug produced by the New England Compounding Center (NECC), in Framingham, Massachusetts. Drug compounding involves reformulating or repackaging approved medicines to better tailor their use to individual patients’ needs. Compounded drugs are not subject to premarket approval like mass-produced medicines, but pharmacies that produce them are regulated by state governments and often by the U.S. Food and Drug Administration (FDA).

After additional cases of fungal meningitis began to appear, public health officials traced the problem to preservative-free doses of injectable methylprednisolone, sold by NECC to treat spine and joint problems. An estimated 14,000 patients in 76 hospitals, medical centers, and clinics in 23 states received injections from the batches of contaminated vials. At least 750 patients have been infected and 64 have died. Within weeks of Lovelace’s death, the FDA instructed NECC to recall thousands of potentially contaminated doses of at least nine of its products. The production facility was shut down, and NECC was forced to surrender its pharmacy license to the Massachusetts Board of Registration in Pharmacy (MBRP).

The FDA’s response did not end there, however. In the face of growing criticism from the medical community, the news media, and Congress for allegedly lax agency oversight, FDA officials went into overdrive to shift responsibility and deny any role in the tragedy. Even though the agency had inspected the NECC facility and threatened enforcement action several times before the meningitis outbreak, senior FDA officials claimed the agency was powerless to have prevented the outbreak and insisted it needed additional authority to prevent such problems from occurring again. It did not take long for members of Congress to introduce new legislation to hand the agency such power.

Yet, the real problem behind this tragedy is not one of FDA impotence. Agency officials have indirectly acknowledged in congressional hearings that they already possess sufficient authority to have prevented the meningitis outbreak. Arguably, the problem can be chalked up to over-regulation and the agency’s abuse of its existing enforcement discretion. The FDA has long neglected its existing authority to regulate large-scale drug compounding, even as agency inspectors knew of specific quality control problems at the NECC facility. In stark contrast, in recent years the agency has become distracted by ever more aggressive enforcement of minor regulatory infractions against manufacturers of approved drugs. All the while, a host of other public policies have contributed to a rapidly rising demand for compounded medicines.

Adding new federal regulations to further restrict compounding would do little but raise the price and reduce the availability of important products for patients who need them.