The U.S. Senate voted Monday to strengthen the Food and Drug Administration's authority over compounding pharmacies that produce large volumes of mixed drugs. The president is expected to sign the legislation, which will reach his desk about a year after drugs distributed by one such compounder led to a deadly multistate meningitis outbreak.
Lauded by supporters as a bicameral and bipartisan effort, the bill would allow the FDA to follow a national standard while regulating facilities making adulterated, misbranded or unapproved products as well as establish a list of drugs that may not be compounded for safety reasons.
Earlier versions of the bill would have required large-scale compounders to register with the federal agency rather than make the registration voluntary. But under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose whether to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy.
“Although it is a scaled-back version of earlier legislation, this bill is an important first step in assuring that compounded sterile products are prepared safely,” said Paul Abramowitz, CEO of the American Society of Health-System Pharmacists.
The FDA traditionally has oversight of drug manufacturing. As more large-scale compounders acted like manufacturers, it became unclear which regulatory bodies were expected to regulate them.
The American Hospital Association has said the bill is a “step in the right direction.”
“Counterfeit and contaminated drugs have taken hundreds of American lives and added hundreds of millions of dollars to our nation's healthcare costs,” said Allan Coukell, senior director of drugs and medical devices at the 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.”
Traditionally, compounding pharmacies mix and prepare drugs for individual patients, some of whom have allergies or other needs. However, during the past, some pharmacies have morphed into manufacturers that mix and ship batches of drugs across state lines to hundreds of providers.
The New England Compounding Center, a now-closed Framingham, Mass.-based compounder, was one of those pharmacies.
State health officials first identified the fungal meningitis outbreak in September 2012. Since then, 64 people have died and more than 700 people were sickened in 20 states after they received steroid injections mixed by NECC, according to the Centers for Disease Control and Prevention.
NECC eventually recalled all of its products and filed for bankruptcy protection. But that hasn't stopped hundreds of patients and their families from filing lawsuits against NECC and Ameridose, a sister company that has also since closed. In some cases, the patients have also sued the healthcare providers that distributed the injections.
The outbreak triggered changes across the entire healthcare supply chain. Some states such as California recently passed stricter laws regulating pharmacies that ship or dispense sterile drug products within state lines, while some providers such as Vanderbilt University Medical Center in Nashville were prompted by the outbreak to move forward with plans to develop their own centralized sterile compounding facilities.
Not all patient advocacy groups have supported the bill. Public Citizen has said the legislation “preserves the provisions that compounding pharmacies have abused under existing law and lax FDA oversight, and that they have used to produce unproven, unsafe drugs.” The organization argued that the FDA already had the authority it needed to regulate compounders such as the NECC. Some Republican lawmakers have said the same thing.
“Ultimately, the FDA knew NECC was breaking the law but chose to do nothing,” Rep. Tom Murphy (R-Pa.) said during a House Energy and Commerce subcommittee hearing in April.
Some experts say that the Drug Quality and Security Act will reduce legal liability for hospitals, which are expected to shift their purchasing practices to the companies that register with the FDA, said Blair Childs, senior vice president of public affairs for Premier. “They tried to make it more market-based,” he said.
In a Sept. 28 letter to Senate and House leaders, Childs said “strong oversight will still be needed by Congress to ensure that high-risk compound manufacturers are inspected by the Food and Drug Administration. In addition, Congress should ensure that drugs in shortage are allowed to be safely compounded to assist with our patient-care needs.”
Ongoing drug shortages are one reason hospitals have increasingly turned to compounders as an alternative source for drugs in short supply. HHS' inspector general's office this year reported that nearly all of the hospitals it surveyed use compounded sterile drugs and about 75% have purchased some compounded drugs from an external pharmacy.