Did FDA have authority to shut down NECC before meningitis outbreak?
The New England Compounding Center (NECC), based in Framingham, Mass., implicated as the source of contaminated steroids, causing more than 130 illnesses and now 12 deaths from meningitis in 10 states, had been warned by the FDA in 2006 about its practices deviating from traditional compounding.
FDA had issued a warning letter, dated Dec. 4, 2006, to NECC for its various practices deviating from traditional compounding of drugs that are not available commercially. In its letter to Barry Cadden, director of pharmacy and owner of NECC, FDA notified him that NECC had several violations that had to be corrected or the agency had the right to “seizure and injunction against you and your firm.“
The violations included mislabeling of compounded trypan blue ophthalmic products, which were available commercially; mislabeling of compounding 20% aminolevulinic acid solution (ALA), also commercially available; promotion and misbranding of a compounded extra-strength, triple-anesthetic cream, failing to provide adequate directions for use; and repackaging of the approved injectable drug Avastin into syringes for promotion and sale to health professionals, which is beyond the practice of pharmacy and subject to premarket approval requirements.
FDA was specifically concerned about opening a sterile container of the Avastin drug and splitting it into multiple doses for single-use, preservative-free vials.
“Pharmacies of any type cannot get around the FDA. The FDA has the ability to walk into any facility where medications are sold, stored, and inventoried. What we know about this particular pharmacy, they had been warned by the FDA multiple times,” said David Miller, executive vice president, International Academy of Compounding Pharmacists, during the Diane Rehm Show, aired Oct. 10.
FDA had visited this pharmacy several times over the last decade and issued a warning. In addition, the Massachusetts Board of Pharmacy also had warned them, according to Miller on the Diane Rehm Show. “If the agencies that are designed to oversee what pharmacies are doing and knew there was a problem, why were these two major red flags to our regulatory agencies not enough to keep an eye on NECC?“
The NECC was acting as “a mini-manufacturer, not a pharmacy,“ Miller continued. NECC was not compounding small batches for individual patients, but was working like a manufacturer, preparing mass quantities back in 2006. In the recent public health outbreak, the contaminated methylprednisolone acetate (PF) (80 mg/mL), prepared by NECC, was used in 75 medical facilities in 23 states, causing the 137 cases of fungal meningitis and 12 deaths so far.
Experts expect the number of cases to continue to rise as the incubation period is up to 3 months from the time of injection. More than 13,000 people were injected with the contaminated steroid vials from three lots that were recalled from NECC on Sept. 26. The recall has been expanded to include all products that were compounded and distributed at its facility in Framingham, Mass. NECC voluntarily surrendered its license to the Massachusetts Board of Registration in Pharmacy, according to an FDA MedWatch report.