By contrast, the federal Food and Drug Administration issued nearly 60 warning letters about unsafe compounded drugs dating to June 2001, the earliest publicly available information, the report found.
“State regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken,” the report said. Industry executives said it was the first state-by-state examination of safety issues like the ones raised by the Massachusetts company that made the tainted steroid injections implicated in the outbreak.
In the wake of the worst public health crisis in recent U.S. history, consumer advocates, members of Congress, and some pharmacy professionals are calling for more FDA authority. Twenty-five people have died and 344 others have been infected from batches of contaminated steroid injections for back and joint pain traced to the New England Compounding Center. About 14,000 people received injections.
“The NECC tragedy is clearly just the tip of an industry iceberg that has long needed reform and federal oversight,” Markey said in a statement.
Traditional compounding pharmacies mix or alter ingredients to make custom medications for individual patients. But in the past two decades, this little-known corner of the pharmaceutical industry has expanded to include large compounders that operate like drug manufacturers.
The FDA regulates drug manufacturers, requiring clinical trials and enforcing rigorous manufacturing standards.But compounding pharmacies are regulated by state boards of pharmacy, which often lack resources to conduct regular inspections. And compounded drugs are not FDA-approved.
The FDA has sought greater oversight, but repeated legal challenges by the industry have restricted its authority, the report noted. The FDA can take action under certain conditions: if compounding pharmacies’ drugs are essentially copies of commercially available products, for example, or if the companies are making drugs before receiving specific prescriptions.
In her first public comment since the outbreak, FDA Commissioner Margaret A. Hamburg acknowledged the agency’s limited authority. There has been “substantial debate” in Congress about the appropriate level of FDA oversight of compounding pharmacies, she said in a statement. “But unfortunately there has been a lack of consensus and many challenges from industry,” she said. “FDA is committed to working with Congress and stakeholders to strengthen the authority we need to help prevent tragedies like this from happening again.”