Most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed 64 people and sickened about 700 others in a fungal outbreak in 20 states.
Today, Congress passed legislation for stricter regulations on them to prevent repeat of what officials have called the "largest documented healthcare-related outbreak in the United States."
"Even in the midst of partisan stalemate, Congress can still come together to pass meaningful legislation to protect the public's health," said Allan Coukell, director of drugs and medical devices at Pew Charitable Trusts. "This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality."
But not everyone is convinced the bill will make patients safer. In fact, some health policy experts say just the opposite.
"It makes what is now illegal legal," said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.
The Drug Quality and Security Act would give large-scale compounding pharmacies the option to register with the Food and Drug Administration and adhere to stricter guidelines for testing and maintaining quality and sterility. In early versions of the bill, these were called "compounding manufacturers," which compounding critics were quick to note suggests that they should be treated like other drug manufacturers and adhere to mandatory guidelines, which the bill does not require. In later versions of the bill, the language was toned down to "outsourcing facilities."
Supporters of the bill hope that compounding pharmacists will want to register with the FDA because doctors will prefer to use compounding pharmacists perceived as safer. Opponents fear compounders won't do it if it's not mandatory.
Carome said he opposes the bill because he said it legalizes a practice that was once illegal -- large scale compounding without individual prescriptions and without following the strictest quality and sterility guidelines that drug manufacturers must follow.
"It makes no sense to have two different tiers of drug manufacturers -- one that has to meet all the manufacturing guidelines and one that only has to meet some of them," Carome said. "We believe in a level playing field."
Traditional compounding pharmacies make drugs for one patient at a time because those patients can't swallow pills, are allergic to an ingredient or have some other special need that prevents them from taking the standard drug. But in recent decades, compounding pharmacists have increasingly made drugs on a scale similar to that of a drug manufacturer, meaning they don't always have prescriptions for individual patients.
"When you mass produce a large number of standard doses of a drug in a single batch, if quality fails, a potential to harm many more people exist," Carome said.
Pew Charitable Trusts supports the bill because it clarifies the existing law, which hasn't been able to keep up with the changing compounding pharmacy industry.
"Over many years, we've had repeated quality problems with compounded drugs," Coukell said. "It really suggests the status quo isn't working."
Shortly after patients began turning up with never-before-seen cases of fungal meningitis, NECC was accused of manufacturing the drugs rather than making them for individual patients. When FDA inspectors arrived at the lab in Framingham, Mass., they found that a quarter of the steroid injections in one of NECC's bins contained "greenish black foreign matter," according to the report. The FDA also identified several cleanrooms that had bacterial or mold overgrowths.