The outbreak of fungal meningitis, which has killed 32 patients in several states since September, has drawn the nation’s attention to risks associated with compounding pharmacies. Fallout from the unfolding tragedy also is highlighting tensions all too predictable among lawmakers, regulators and the industry, as Congress investigates the incident.
Contaminated vials of steroid injections manufactured by a Massachusetts company, the New England Compounding Center, were shipped to clients in 19 states, including Ohio. The product has been linked to more than 450 cases of meningitis infections, raising questions about the oversight of compounding pharmacies whose operations have expanded beyond customizing limited quantities of drugs for use by individual patients.
At Senate and House hearings this week, Margaret Hamburg, the commissioner of the Food and Drug Administration, pointed to “an enormous lack of clarity.” She asked that Congress clarify and strengthen the authority of the federal agency to oversee compounders that operate on a large scale like the Massachusetts company, their products reaching thousands of patients in multiple states. Investigators have uncovered numerous violations of safety requirements at the company, suggesting that large-scale compounders rapidly are outgrowing the capacity of states to oversee them effectively
The trade group for compounding pharmacies adamantly opposes any new federal regulations. It argues — and gets much sympathy from a Republican House skeptical of regulations — that the FDA already has the oversight authority it needs but failed to apply it in this instance.
It is hardly unreasonable to put pharmacies that are drug manufacturers in all but name under the same regulatory umbrella, responsible to meet similar product-safety standards.