Mistakes, and meningitis

Opinion: October 19, 2012 at 12:00a.m.

Los Angeles Times: The 14 people who died of fungal meningitis after they were injected with an apparently tainted steroid surely had no idea that their medication hadn’t come from a regular pharmaceutical company that meets federal standards for safety and efficacy. Rather, it had been produced by one of the nation’s “compounding pharmacies,” which used to be small operations producing customized versions of drugs for people whose particular medical issues made it difficult for them to take standard medications. Because of their small, specialized operations, such businesses have been largely exempted from inspection and regulation by the U.S. Food and Drug Administration.

Yet many of them have grown into sizable manufacturers that make the same drugs produced by traditional pharmaceutical companies. The injectable steroid implicated in the meningitis cases, for example, was shipped to nearly two dozen states and used to treat up to 14,000 patients with back or neck pain. This has been possible in part because of provisions of the 1997 Food and Drug Administration Modernization Act, which allowed compounding pharmacies to avoid the levels of testing and other standards required of regular pharmaceutical firms. Court decisions further tied the FDA’s hands.

In 2003, an FDA official raised his concern about various compounding firms before a Senate committee, saying that some had “creatively marketed” new products that they touted as superior to available drugs without data to support their claims.

Now Congress must plug this growing hole in regulatory oversight by giving the FDA clear and unequivocal authority over compounding pharmacies.