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.
NECC owner Barry Cadden was subpoenaed to appear before Congress a year ago, but he declined to answer questions, invoking his Fifth Amendment right against self-incrimination.
The FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.
According to FDA records, there have been 22 compounding pharmacy recalls since last March. But there are no compounding pharmacy records in the database prior to that date going back five years -- though there may have been state recalls.
"I think the FDA realizes its own failure to act swiftly in the NECC case and that has elevated their scrutiny of compounding pharmacies to the point where [they] cannot -- [they] do not want to be put in the position of being accused of not taking swift action," said David Miller, president of the International Academy of Compounding Pharmacists, which had historically lobbied for looser oversight by the FDA in decades past, but last year blamed the FDA for not shutting down NECC.
Prior to the NECC outbreak, compounding pharmacies were regulated by state pharmacy boards, and the FDA said it didn't have the authority to properly regulate the industry. Its hope was that new legislation would change that.
Still, FDA officials said they are pleased with the new legislation.
"While this bill does not provide FDA with the additional authorities it sought, it provides a regulatory framework for certain compounders who register with the FDA," said FDA spokeswoman Erica Jefferson.
Compounding pharmacists who do not register with the FDA will be subject to the existing law, which is part of the Federal Food, Drug, and Cosmetic Act. This mandates that prescriptions be made for each patient individually, rather than in bulk, and has slightly less rigorous guidelines for quality and sterility testing.
Any compounding pharmacy that isn't compounding prescriptions for only individual patients would be acting illegally under the proposed law, but it doesn't provide a way for the FDA to figure out which pharmacies are misbehaving. That will still be up to state inspectors.
"The agency will continue enforcing the law to the full extent of its authority in order to protect public health," Jefferson said.