October 9, 2012

THIS YEAR, a company in Framingham, Mass., the New England Compounding Center, shipped 17,676 steroid injections for back pain to clinics in 23 states. Some of the injections were contaminated with a fungus that has led to a meningitis outbreak in 10 states, including Maryland and Virginia, in which 119 people have been sickened and 11 have died. The Centers for Disease Control and Prevention estimates that some 13,000 people got the injections, starting May 21. The outbreak has revealed breakdowns in the oversight of businesses known as compounding pharmacies.

Compounding is a traditional part of pharmacy practice. It means that a pharmacist combines, mixes or alters ingredients to create a medication for an individual patient. Usually, it is done to prepare a medicine that is not commercially available, such as for a patient with an allergy to a specific ingredient. However, in the past two decades, businesses with pharmacy licenses have sprung up to use compounding for the production of medicines in quantities rivaling that of drug manufacturers. The New England Compounding Center seems to be one of these large-scale producers, hardly a corner pharmacy.

The Food and Drug Administration (FDA), which imposes strict standards on drugmakers, has long worried about compounding pharmacies. The businesses do not have to register with the FDA. In 2006, an FDA survey found problems with one-third of the drugs it sampled nationwide from compounding pharmacies. An FDA consumer flier in 2007 warned that “poor practices on the part of drug compounders can result in contamination or in products that don’t possess the strength, quality and purity required.” However, several court decisions over the past decade have limited the agency’s enforcement powers over compounding pharmacies, which fall largely under state law, where regulation and enforcement are uneven.

Precisely what went wrong at the New England Compounding Center — causing some kind of fungal contamination — is not yet known. There are voluntary industry standards for testing; were these medicines properly scrutinized for potency, sterility and toxic substances? The Massachusetts Department of Public Health says that state rules allow pharmacies to dispense compounded drugs only for the prescription of an individual patient. A good question is whether the New England Compounding Center followed this rule in shipping tens of thousands of doses.

The outbreak raises broader policy questions. In 1997, Congress passed legislation establishing state and federal regulation of compounding pharmacies. But the federal role was challenged by some pharmacies in the courts, and it has been caught up in legal wrangling for years. The FDA has attempted to keep watch with “policy guidance” instead of law, and the agency initiated enforcement actions when abuses became apparent. But this lack of clarity has led to serious gaps in oversight. Congress should give the FDA power to oversee any company engaging in large-scale production of drugs and to make sure they meet federal standards for safety and good manufacturing practices.