SILVER SPRING, Md. — US Food and Drug Administration officials met in an open forum with state health representatives Wednesday to come up with a framework for new federal laws that would tighten oversight of compounding pharmacies such as the Massachusetts company blamed for the national fungal meningitis outbreak.
The FDA regulates drug manufacturers but not compounders, which typically custom make medicines for individual patients, such as those who cannot take standard versions of drugs. Regulators say New England Compounding Center in Framingham produced medications in bulk and distributed drugs nationwide, much like a manufacturer, in violation of its state license.
“This case with NECC clearly shined a very harsh spotlight on the fact that compounding pharmacy entities need a more comprehensive, consistent, and strong regulatory system,” Dr. Margaret Hamburg, the FDA commissioner, said during a press briefing. “How can we move to ensure that this kind of event doesn’t happen again?”
Batches of steroid injections produced by New England Compounding became contaminated with a fungus and were injected into roughly 14,000 patients, resulting in 39 deaths and 620 cases of meningitis across 19 states this past summer and fall.
In an article published online by the New England Journal of Medicine Wednesday, the Centers for Disease Control and Prevention concluded that about 4 percent of the 14,000 patients exposed to the contaminated steroids have become sick so far.
You have reached the limit of 5 free articles in a month
Stay informed with unlimited access to Boston’s trusted news source.
- High-quality journalism from the region’s largest newsroom
- Convenient access across all of your devices
- Today’s Headlines daily newsletter
- Subscriber-only access to exclusive offers, events, contests, eBooks, and more
- Less than 25¢ a week