I hope that SOMEBODY goes to jail for a long time on this...
The New England Compounding Center in Framingham, Mass. was not following the requirements of its state license, according to a spokeswoman for the Massachusetts Department of Public Health.
Dr. Madeleine Biondolillo, director of the state's Bureau of Health Care Safety and Quality, said the company was meant to make up drugs only in response to a doctor's prescription for an individual patient.
"This organization chose to apparently violate the licensing regulations under which they were allowed to operate," Biondolillo told reporters in a telephone news conference Thursday.
FDA spokeswoman Dr. Deborah Autor told MedPage Today the agency has legal remedies available, including the ability to seize products and to lay criminal charges, but she did not elaborate further.
A 2006 warning letter to the company, charging it was acting more like a drug manufacturing firm than a compounding pharmacy, elicited assurances that patient safety was being protected and that applicable laws and regulations were being obeyed, Autor said.
The CDC is now reporting 170 cases in 10 states of fungal infection associated with the steroid, preservative-free methylprednisolone acetate, including 14 deaths.
That's an increase of 33 cases and two deaths from Wednesday.