In the wake of a nationwide fungal meningitis outbreak that has sickened more than 500 people and killed at least 36 people, the prominent consumer watchdog group Public Citizen is calling for an immediate re-inspection of any compounding pharmacy that has previously received a warning letter from federal regulators.
In a letter sent to FDA Commissioner Margaret Hamburg on November 29, Public Citizen called on the agency to investigate any compounding pharmacy that is still operating after prior concerns were raised under a regulatory scheme that allowed known dangerous conditions at a Massachusetts pharmacy to result in the shipment of contaminated medications throughout the United States.
Public Citizen conducted its own review of FDA records and found that between 2003 and 2012, the FDA sent warning letters to 16 compounding pharmacies in 15 states. Five of the warning letters involved patient injuries and deaths linked to drugs compounded at the pharmacies, according to the watchdog group.
Numerous letters identified activities that were outside of the bounds of compounding pharmacies, which are supposed to be restricted to making drugs on a per-patient basis for local hospitals when that particular drug or variant is not available through a commercial drug.
Other Pharmacies Linked to Deaths, Illegal Activities, Still Operating
The request to have them all re-inspected comes following revelations that federal and state investigators knew there was a history of problems at the New England Compounding Center (NECC), which has been identified as the source of contaminated medications that caused the recent outbreak of fungal meningitis and other infections linked to compounded epidural steroid injections.
During the fallout from the outbreak, the FDA and other regulatory agencies have faced sharp criticism. Although FDA inspection reports prior to the outbreak identified unsafe practices at NECC, the FDA has maintained that it did not have the authority to shut NECC down, which some experts and lawmakers have disputed.
“The FDA’s warning letters show that the agency doesn’t need any additional actions by Congress to enforce the Food, Drug, and Cosmetics Act against pharmacies that engage in illegal drug manufacturing,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a press release. “By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens.”
NECC Recall Too Late to Prevent Outbreak, Deaths
In September, health officials linked epidural steroid injections distributed by NECC to a nationwide outbreak of fungal meningitis. The compounding pharmacy has now been shut down, issued a steroid injection recall, and later recalled all of its products and lost its license.
By then, NECC had already shipped about 17,000 tainted vials of steroids to 23 states. U.S. health officials estimate about 14,000 people were injected with potentially contaminated drugs as a result.
Subsequent investigations of NECC’s facilities found serious sterility problems and detected the same fungi linked to the outbreak in still-sealed drug vials at the company’s Massachusetts facility. In some cases there were visible globs of fungus reportedly seen floating in supposedly sterile drug vials.
A number of fungal meningitis lawsuits are now being pursued on behalf of individuals who received a steroid injection from NECC, however substantial concerns exist about the ability of this company to properly compensate all of the people who have been damaged.