The Food and Drug Administration should be given new regulatory powers to prevent a repeat of the ongoing fungal meningitis debacle, the nation's oldest medical journal says.
“The current system, in which regulation is almost entirely state-based, is clearly inadequate to protect the public health,” wrote the New England Journal of Medicine in an editorial published online on Wednesday.
The meningitis outbreak has sickened 414 people nationwide since early September. Thirty-one have died. The rare fungal version of the disease has been linked to steroid injections produced by the Massachusetts-based New England Compounding Center.
The Massachusetts health department fired the head of its pharmacy board on Wednesday, saying he had failed to follow up on a complaint about the facility earlier this year.
The company closed last month and recalled all of its products. FDA investigators have reported finding mold and bacteria in “clean rooms” where the compounding pharmacy – a firm that makes special types and combinations of medicines to order – mixed its products.
The New England Journal endorses a bill by Massachusetts Congressman Ed Markey that would retain state control over traditional compounding pharmacies, which make drugs for individual patients, but give the FDA responsibility for those that operate as larger-scale drug manufacturers.
“Regulators need a strong mandate to protect the public health. Too many patients have suffered and died as a result of compounding errors, which should be made a thing of the past,” the editorial concludes.
The International Academy of Compounding Pharmacists, however, says it's not convinced more regulations are the answer.
“If both the state and the FDA knew of problems at NECC – and did based on publicly disclosed documents – why did they fail to follow-up or take action?” the industry group wrote on its website Wednesday. “New regulations or new laws are meaningless if the regulatory agencies charged with upholding them simply fail to do their job.”
Reuters has detailed the industry's decade-long battle to avoid FDA oversight.
U.S. House and Senate committees have both scheduled hearings into the meningitis outbreak next week. The House subpoenaed the New England Compounding Center's chief pharmacist on Tuesday after he refused to appear before the committee voluntarily.