The head of the FDA is calling for new powers that will help the agency better regulate and oversee the compounding pharmacy industry, hoping to prevent quality control problems that allowed one Massachusetts pharmacy to distribute thousands of contaminated epidural steroid injections that caused fungal meningitis infections to develop in hundreds of people nationwide late last year.
The outbreak was traced back to epidural steroid injections distributed by the New England Compounding Center (NECC) that were not sterile. The pharmacy sold 17,000 of the injections nationwide, exposing about 14,000 patients and causing more than 700 people have fall ill, with nearly 50 deaths linked to the infections.
While compounding pharmacies are supposed to only provide local hospitals with drugs that are not available from manufacturers on a per-prescription basis, NECC and some other compounding pharmacies have been working as stealth drug manufacturers, producing large quantities of medications and distributing them throughout the country.
FDA Claims Its Hands Were Tied
Following the outbreak, information surfaced that suggested the FDA knew about quality control problems at the NECC facility for years. However, the agency has maintained that its hands were tied by regulatory limits on what authority the agency is able to exercise over the compounding pharmacy industry.
“While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again,” Hamburg wrote. “But our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate.”
Some lawmakers have resisted the push for increased FDA powers, saying that the agency had the ability to intervene with its existing regulatory power. FDA officials disagree with those lawmakers’ legal interpretations.
Hamburg says that a “new breed” of compounding pharmacies have come into being and the law has failed to keep up with their practices. These pharmacies can threaten public health and require new laws.
NECC Faces Lawsuits, Criminal Charges
NECC lost its license and faces criminal probes both because of its failure to sterilize its drugs properly, and because of its distribution practices, which were seen as a violation of its compounding pharmacy license.
The FDA, Massachusetts, Florida, Iowa and other states have begun surprise inspections of compounding pharmacies in recent months. The FDA cited four pharmacies for violations earlier this month.
Earlier this year, the Massachusetts Department of Public Health ordered 11 compounding pharmacies to partially or completely shut down operations due to violations. Another 21 received citations.
Iowa is in the process of inspecting 80 pharmacies that supply drugs to its state, including some in other states. It has already issued citations against five compounding pharmacies. Those charges include allegations of unlawful drug manufacturing.
NECC faces a growing number of fungal meningitis lawsuits following the outbreak, and declared bankruptcy late last year under the weight of its legal troubles.