By Nick Taylor
Criminal investigators have searched the Massachusetts compounding pharmacy linked to the deadly outbreak of fungal meningitis. FDA and Department of Justice investigators arrived at the site with a search warrant to ratchet up their investigations into the New England Compounding Center.
With the outbreak now linked to 15 deaths, authorities are under pressure to identify the cause of the outbreak and have headed to the suspected source. Criminal investigators were at the site Tuesday, but it is unclear what--if anything--they uncovered. FDA staff and attorneys linked to the case are remaining tight-lipped, with the latter saying it is "entirely premature" to discuss the outcome of the investigation.
The FDA is running an ongoing investigation into the compounding pharmacy, although NECC claims that it is complying with the agency to such an extent that the search was unnecessary. "It is difficult to understand the purpose of this search, since we have been clear that New England Compounding Center would provide, and has provided, anything requested. We've been clear that warrants weren't needed; asking would have produced the same result," NECC attorney Paul Cirel told CNN.
It isn't the first time NECC and the FDA have clashed. In 2006, the FDA sent a warning letter to NECC for repackaging Avastin and other actions that went beyond the remit of compounding pharmacies. The warning letter was one in a series of disputes between the FDA and compounding pharmacies over the past decade. As Reuters reported this week, the FDA efforts to gain greater oversight of compounding pharmacies were opposed by organized lobbying campaigns.
The high profile of the meningitis outbreak could catalyze change, though. Massachusetts Gov. Deval Patrick has accused NECC of misleading regulators, and Congress has expanded an investigation into the outbreak. Meanwhile, the first lawsuit has arrived, with a Minnesota woman alleging that she was injected with tainted steroids from NECC.
- read CNN's article
- check out the 2006 warning letter
- here's news of the lawsuit