Federal criminal investigators raid tainted steroid maker NECC


2012-10-17 14:46

On the evening of October 16, criminal investigators with the Department of Justice (DOJ) and the Food and Drug Administration (FDA) searched the New England Compounding Center (NECC), which is implicated in the multi-state outbreak of virulent fungal meningitis. Neither agency would comment on what they were looking for; however, two members of Congress have asked the DOJ to investigate whether the compounding center has violated any federal regulations. As the investigation heats up, the 14,000 individuals who received a steroid injection compounded by NECC are extremely concerned that they might contract a deadly fungal meningitis infection.

To date, 233 cases have been reported and at least 16 individuals have died from fungal meningitis; however, many of the stricken individuals are seriously ill and some have suffered strokes. The incubation period varies for this type of infections; thus, more cases are likely to surface over the next few weeks. Virtually all 14,000 patients are still at risk.

Rep. Edward Markey (D-Mass) wrote a letter to the DOJ: “This is a matter that I believe requires further investigation by the [Drug Enforcement Administration] to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances.” Massachusetts authorities have alleged that the NECC exceeded its authorization as a compounding pharmacy to mix or alter drugs for patient-specific prescriptions. “What they were doing instead is making big batches and selling out of state as a manufacturer would,” Gov. Deval Patrick (D-Mass) told reporters last week.

US Attorney Carmen Ortiz of the District of Massachusetts wrote, “I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center. I think that it is entirely premature to suggest what the results of the investigation will be.” Paul Cirel, an attorney representing NECC claimed that the federal raid of the compounding center was unnecessary. He noted, “We’ve been clear that warrants weren’t needed. Asking would have produced the same result. Nevertheless, we continue to offer our cooperation.”

In addition to the tainted steroid injections, pharmaceuticals made at the New England Compounding Company (NECC) may have caused other types of infections. On October 15, the Food and Drug Administration (FDA) reported that the compounding center may have made products that caused infections in patients who underwent eye or open-heart surgery. In addition, another NECC product, an epidural injection of the steroid triamcinolone acetonide, is linked to a meningitis case.

Reference: FDA

See also:
FDA warns of risk from other tainted drugs produced by NECC
Company responsible for fungal meningitis cases skirted state and federal laws
Fungal meningitis stats continue to worsen
Fungal meningitis outbreak raises safety issues regarding compounding pharmacies
CDC reports that thousands received tainted epidural injections