That a batch of tainted vials from a single company could put thousands of people across the country at risk for a deadly form of meningitis is a sign the system for regulating pharmacies that mix drug compounds and ship them nationwide needs to be overhauled. Roughly 14,000 people may have received contaminated shots of a steroid used to treat back pain from the New England Compounding Center in Framingham, Mass. So far, 304 people in 17 states have become ill — including 13 in Maryland — and 24 have died, with those numbers expected to rise. The risks to public health exposed by the outbreak clearly demand prompt action by Congress to strengthen the Food and Drug Administration's power to protect Americans from tainted medicines.
Traditionally, compounding pharmacies were small-scale enterprises that mixed ingredients in limited quantities for patients who needed specialized medications that were either unavailable from large pharmaceutical manufacturers or too expensive when purchased that way. They typically served local doctors and clinics that needed customized drug mixtures tailored to the requirements of individual patients.
But New England Compounding Center represents a new kind of compounding pharmacy that mixes enormous batches of drugs, some identical to those produced by large drug manufacturers, and sends them around the country. It's closer to the mass-production operations of the pharmaceutical giants than to the mom-and-pop shops of yore, or even to the local compounding pharmacies found in many hospitals. Because the company is still classified as a pharmacy rather than a drug manufacturer, however, the FDA has far less oversight and regulatory authority over it than over other large-scale commercial manufacturers.
Instead, that task falls to state health departments, which often have neither the personnel nor the resources to adequately regulate such businesses. That has left companies like New England Compounding in a virtual legal no man's land where they're free to operate pretty much as they please, with minimal oversight from either federal or state authorities.
Massachusetts officials investigating the company's practices after the fact found that it failed to keep its facility clean or maintain a sterile environment, which allowed its drugs to become infected with a deadly fungus that can cause meningitis in people injected with contaminated drugs. In at least one case, the contamination was so obvious that the foreign particles were visible to the eye inside vials containing the medication.
At the site of the company's factory, investigators described a filthy, unsanitary environment with malfunctioning equipment where employees failed to disinfect products "even for the minimum amount of time necessary to ensure sterility." What's more, the company had a history of complaints about its products going back more than a decade. Yet no one seems to have been in a position to put a stop to the abuses.
This week, the FDA released a list of 89 medical facilities in Maryland that had purchased drugs from New England Compounding Center, including the University of Maryland Medical Center, Greater Baltimore Medical Center and Northwest Hospital, as well as doctors' offices, clinics and injury rehabilitation facilities. It appears that only a handful of them bought the injectable steroid linked to the recent outbreak of meningitis, but federal regulators clearly want the medical community and the public to be on the lookout for other potential risks from tainted medications. Nationwide, more than 3,000 facilities in 23 states have received the company's products.
That hardly sounds like the work of a mom-and-pop outfit. Congress needs to give the FDA the same authority to inspect production facilities, mandate rigorous standards for safety and effectiveness and monitor sales at large compounding pharmacies that the agency has over major drug companies. This should be a wake-up call regarding the need for tougher federal regulation in an area that has the potential to cause even more serious problems down the road if not promptly addressed.