Wednesday, October 17, 2012
Meningitis Outbreak Grows; NECC Communication Shrinks
State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products. The outbreak has raised questions about how the pharmaceuticals industry operates. NECC engaged in a practice called drug compounding that is not regulated by the FDA, which generally oversees drug manufacturers. NECC's crisis mounted as more victims of meningitis filed lawsuits, including two by Michigan residents this week.
Rep. Edward Markey (D-Mass), in a letter to the Department of Justice, wrote, "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 went beyond 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. In a statement from the DOJ, U.S. 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.'"
"Precautionary?" There are 231 victims and counting. Sixteen are dead. NECC at the very least should be expressing its sympathy and regrets. It needs to be aiding the most seriously infected victims -- primarily the very young and the very old -- to show it cares and wants to make things right. Organizations that remain out of sight during a crisis risk appearing guilty and drawing more civil suits. Openness may not save the company at this point, but I don't see what it would hurt.