A deadly national meningitis outbreak, which stemmed from a batch of tainted steroids sold by a Framingham company, has rightly launched fierce reactions from state and federal officials. The Patrick administration is taking necessary steps to scrutinize the actions of the New England Compounding Company and its sister company, Ameridose — and to ensure that all Massachusetts pharmacies are complying with state regulations. But this crisis has also shed attention on the murky world of compounding pharmacies, and the reasons why they need to be subject to more of the national rules that govern prescription drugs.
Compounding pharmacies have existed since the 1700s and are intended to serve a particular health care purpose: They prepare medications for people who can’t take them in traditional forms, such as by producing a liquid dosage or injection for someone who can’t swallow a pill. But while these companies once tended to be small, local operations, many are now big businesses. Massachusetts has 26 compounding pharmacies that account for 37 million prescriptions per year. Many operate across state lines amid surprisingly limited oversight. Large drug manufacturers are subject to an arduous approval process from the Food and Drug Administration, but compounding pharmacies operate outside of the agency’s regulatory framework, and the industry has aggressively fought against increased regulation.
As it stands, regulation of these pharmacies is left to state agencies that often have scant resources, and to a patchwork of rules that varies by state. Massachusetts, for instance, bars these pharmacies from issuing drug preparations without prescriptions — to customers in this state or others. But it’s unclear how closely that rule has been followed, and not every state has a similar rule for compounding pharmacies within its borders. Representative Ed Markey plans to introduce a bill that would tighten federal oversight, requiring pharmacies that engage in interstate commerce to register with the FDA, and allowing the FDA to perform safety inspections. The bill would also ban compounding pharmacies from using ingredients that are not approved by the FDA — a practice that wasn’t a factor in this meningitis outbreak, but could pose a public health risk in the future.
Massachusetts’ relatively strict oversight provisions have helped this investigation proceed swiftly, increasing the odds that most of the 14,000 patients exposed to the compounding pharmacy’s products will be able to protect themselves with antifungal medication. But the state will have to look closely at whether its oversight of New England Compounding was thorough and sufficient. That’s why Markey’s bill, requiring broader federal oversight, is a good idea. When a business operates at the heart of public safety, the public should have every expectation that it follows the rules — and that there are standard rules to follow.