Co-owner of pharmacy at center of meningitis outbreak was faulted
Years before meningitis outbreak, Barry Cadden was uncooperative with FDA, congressional staff says
Smith noted that “the board staff who are responsible” have been removed. James D. Coffey, the board’s director, was fired last week, and the board’s attorney was placed on leave.
One week after the inspection in September 2004, during which investigators found Trypan blue in the drawer, FDA investigators had another tense encounter with Cadden and his brother-in-law Gregory Conigliaro, a co-owner of New England Compounding Center, according to the staffers’ memo.
When an investigator asked Conigliaro why the pharmacy was making the eye medication, even though it was not an FDA-approved product, “he became indignant [and] he said that he does not really have the time to sit with us [and] answer all those questions,” the investigator wrote in his report. Cadden told his brother-in-law, “Don’t answer any more questions!”
In a related development Monday, the FDA released a report detailing 15 problems that inspectors found during an investigation at Ameridose — New England Compounding’s sister company and a major supplier to hospitals — ranging from insufficient testing of the sterility and potency of drugs to the presence of insects and a bird in an area where sterile products were packaged and stored.
US Representative Edward J. Markey, a Massachusetts Democrat and a member of the oversight and investigations subcommittee, said in a statement yesterday that the “shared ownership of NECC and Ameridose resulted in shared disregard for basic safety and sterility procedures for manufacturing drugs. Barry Cadden will have much to answer for when he appears before Congress this week at hearings, and I plan to ask state and federal authorities how these companies were able to fall through regulatory cracks and serious violations go unaddressed.”
Officials from the Centers for Disease Control and Prevention said they do not know when the outbreak will abate.
None of the fungal meningitis cases has taken longer than six weeks, from the time of injection, to diagnose. Last Wednesday marked six weeks from the day drugs produced at the Framingham pharmacy were recalled and public health officials began collecting products left over. But public health officials said they are not ready to declare the danger past. “We don’t know the ultimate incubation period, so anyone that received an injection should continue to be vigilant,” said CDC spokesman Curtis Allen.
Carolyn Y. Johnson and Chelsea Conaboy of the Globe staff contributed to this story. Liz Kowalczyk can be reached at email@example.com.