Fungal Meningitis Outbreak Highlights an Ineffective FDA
Federal regulators were stunningly ineffective in policing the New England Compounding Center (NECC), the Massachusetts-based compounding pharmacy at the center of a multistate fungal meningitis outbreak that has sickened hundreds of people and killed more than 30. According to a report from The New York Times, the U.S. Food & Drug Administration (FDA) threatened on several occasions to bring its full force to bear on NECC, only to later back off by citing a lack of jurisdiction.
Compounding pharmacies like NECC, which traditionally prepared custom medications for individual patients, are lightly regulated by the FDA. For the most part, the majority of oversight is left up to state regulators. But over the years, more compounding pharmacies have begun operating as major drug suppliers for hospitals and other healthcare facilities. The recent fungal meningitis outbreak, which has been blamed on tainted epidural steroid injections supplied by NECC, has prompted the FDA to seek more authority to regulate these facilities.
According to the recent New York Times report, when it came to regulating NECC, the FDA did not make much use of the power it currently does have. Among other things, documents examined by the Times show the agency was sometimes slow in pursuing its own inspection findings. For example, the FDA took 684 days to issue a warning letter to the company after finding violations at its Framingham facility during an inspection that began in September 2004 and ended in January 2005. NECC’s chief pharmacist later complained that some of the assertions made in the December 2006 letter no longer applied to its operations, the Times said.
At other times, the FDA backed off taking action against NECC after the company challenged the agency’s legal authority to regulate it, refused to provide records and continued to ship a drug in defiance of the agency’s concerns.
NECC’s epidural steroid injections have been blamed for 490 illnesses so far, including 34 deaths. According to the U.S. Centers for Disease Control (CDC), 478 people who received the steroid injections for back pain have become ill with fungal meningitis, while 12 have suffered peripheral joint infections after being treated for joint pain.
An FDA inspection conducted at NECC in the wake of the outbreak uncovered unsanitary conditions, including contaminated steroids. The company has since voluntarily surrendered its license to operate and has issued a recall for all of its drugs. NECC is also facing more than two dozen fungal meningitis lawsuits filed in federal courts throughout the U.S.