Americans are understandably inclined to believe that the medicines prescribed for them are approved and provided under the safety regulations of the federal Food and Drug Administration. And in most instances, that’s true. But as the current multistate outbreak of 105 meningitis cases and eight deaths (half of the latter in Tennessee) linked to spinal epidural injections shows, that’s not always the case. The problem appears to lie with the growth of so-called compounding companies that do not fall under FDA oversight.
State-regulated pharmacies are allowed to create, or compound, specialty medicines to fill local physicians’ prescriptions for patients’ special needs. Given the supply-and-demand economics that tilt pharmaceutical plants toward high-volume production, however, some of these local compounding operations in recent years have apparently assumed the role of small manufacturing plants for specialty drugs. They’ve filled a niche market that FDA-regulated drug makers have either neglected, abandoned or not fully served.
That may be a theoretically sound free market dynamic, but it has let regulatory authority for these plants fall haphazardly to an obviously inadequate patchwork of state regulation. Even as some of these compounding plants have developed regional and national distribution networks, they’ve been allowed to skirt the FDA regulatory oversight that applies to traditional pharmaceutical companies. Indeed, their ability to provide specialty drugs to doctors and hospitals that have not been approved by the FDA has, ironically, further aided their growth, especially for drugs that are significantly more expensive if obtained from a pharmaceutical maker regulated by the FDA.
This is apparently what happened with the injectable steroid methylprednisolone, which may be mixed with a numbing agent and/or a preservative, like alcohol. Spinal neurologists use the drug to treat severe pain emanating from inflamed nerves. It’s especially noted for its treatment of pain of the sciatic nerve caused by pressure from injured or deteriorating vertebrae and discs. In fact, some 5 million Americans — half of them Medicare recipients — received such lumbar injections in 2011.
New England Compounding, a Massachusetts operation and one of the nation’s larger compounding companies, is now suspected of distributing batches of the drug since mid-May that were contaminated by bacterial fungi, which reportedly caused the current outbreak of non-communicable but potentially crippling or lethal meningitis.
Two large pharmaceutical manufacturers of the generic version of the drug, research by The New York Times found, had halted production of the drug in the U.S. — Teva in 2010, and Sandoz this year. Both had been cited by the FDA for quality issues. Their retreat from the market may have created a shortage of the medicine, and more business for New England Compounding.
The investigation of the meningitis outbreak isn’t yet complete. But what is already known is troubling enough. Compounding operations that establish manufacturing facilities of scale and range that enable them to compete with FDA-regulated pharmaceutical companies should fall under FDA oversight. Congress should ensure that that happens, and free-market critics of government regulation should support the use of FDA rules in the interest of safety for patients who rely on reasonable standards to protect their health and lives.