Mass. pharmacy founder had background in recycling
Conigliaro's success at the recycling company was repeated at the compounding pharmacy, and in 2006, the partners started another pharmacy, Ameridose, which would eventually report annual revenue of $100 million — more than 10 times NECC's. Ameridose products haven't been linked to any problems, but the pharmacy in Westborough has ceased operations while state and federal authorities inspect it.
Cadden has surrendered his pharmacy license and resigned from Ameridose. Neither man responded to requests for comment; a company spokesman said they are focused on helping investigators in the meningitis outbreak.
Some pharmacists who have done business with NECC said they were blindsided by the crisis.
"A great company to work with, very responsive to our needs," said Joe Allessandrini, assistant vice president of clinical services at South Jersey Healthcare. "This is, as I'm sure you're hearing from other people, a shock to us."
State officials have inspected NECC at various times, most recently last March, following a complaint about the potency of a product used in eye surgery. The results of that inspection have not been released, and state officials said the complaint appears unrelated to the meningitis outbreak.
However, NECC was licensed only to fill individual patients' prescriptions, state officials said. Authorities said it may have been operating beyond its legal boundaries by shipping products for broad use around the country. Compounding pharmacies are more lightly regulated than pharmaceutical makers, and their products are not subject to Food and Drug Administration approval.
"The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer," said Rep. Edward Markey, D-Mass., who sits on the Energy and Commerce Committee, which has jurisdiction over the FDA.
Ameridose is regulated by the FDA, and in 2008 an FDA investigator found problems with its records, procedures and testing of drug products. Among the issues: Finished drug products were shipped before the company received results of a 14-day sterility test, according to Inspection Monitor, a trade newsletter that covers FDA inspections. Representatives of Ameridose and FDA did not return calls for comment.
Associated Press writers Holbrook Mohr in Jackson, Miss., Linda Johnson in Trenton, N.J., and Rodrique Ngowi in Boston contributed to this report.