(Story updated at 7 p.m. ET.)
The indictment of 14 people Wednesday—including two pharmacists on charges of second-degree murder—was the latest in a string of actions taken in response to a deadly 2012 fungal meningitis outbreak linked to a Massachusetts compounder.
More than 750 people in 20 states fell ill and 64 people died as a result of the outbreak, which was blamed on a tainted steroid produced by the New England Compounding Center in Framingham. Many saw the tragedy as a call to action, and since then, the government has taken a number of steps to make such compounders safer, experts say.
The 14 defendants now facing charges include former pharmacists, a director of operations, the national sales director, an unlicensed pharmacy technician, two owners and one other. Two of the individuals have been charged with 25 acts of second-degree murder in seven states, and the other 12 face charges including racketeering, mail fraud, conspiracy, contempt, structuring and violations of the Food, Drug and Cosmetic Act.
“Since that outbreak there's been a lot that's been done” to improve the oversight of compounding pharmacies, said Allen Vaida, executive vice president of the Institute for Safe Medication Practices. “Overall, yeah, we do feel that they're safer now.”
During the outbreak, Food and Drug Administration Commissioner Dr. Margaret Hamburg argued that the agency had limited authority to police compounders because they are not viewed as drug manufacturers under the law. Congress passed legislation in 2013 to strengthen the FDA's authority over compounders that produce large volumes of mixed drugs and ship them across state lines. That legislation, among other things, allows such pharmacies to voluntarily register as outsourcing facilities so they're regulated by the FDA rather than state boards of pharmacy.
State boards of pharmacy have also been training inspectors on how to make sure such pharmacies are following certain standards, Vaida said.