Ex NECC Sales Chief Details Ruses

By Walter F. Roche Jr.


BOSTON- The former sale manager for a defunct drug compounding company testified in federal court today that the company used fake patient names, contracts and other ruses to convince regulators that they were operating like a regular pharmacy thus avoiding much tighter regulation by the federal government.
Robert Ronzio, who was testifying under the terms of a plea agreement with federal prosecutors, told jurors said that when a Tennessee customer started to ask too many questions about the New England Compounding Center's practices, he just walked away for fear that Tennessee regulators would catch on and bar them from selling any products in the state.
"Potentially we could lose the whole state," he said.
His testimony came in the trial of two former pharmacists, Kathy Chin and Michelle Thomas, for the drug compounding firm who are charged with violations of the federal Food Drug and Cosmetic Act.
Without individual prescriptions, Ronzio said, the company would be in violation of state and federal law.
Ronzio has entered a guilty plea to the charge that he conspired with others at NECC to defraud the U.S. Food and Drug Administration. Under questioning by Assistant U.S. Attorney Amanda Strachan, Ronzio said his agreement required him "to tell the truth." He has yet to be sentenced.
He said he went to work for NECC and a related sales company in 2010 and got a crash course in the drug company jargon from NECC's president and part-owner Barry J. Cadden. Cadden is now serving a nine year federal prison sentence following his conviction on racketeering and mail fraud charges.
"I couldn't pronounce the names of medications," he said of his first days at NECC.
He said NECC sometimes used a process dubbed back-filling to generate the required patient specific prescriptions. Customers, hospitals and clinics, would send NECC the list of prior patients to justify new orders.
With Cadden's approval, Ronzio said, some customers, depending on volume, were exempted from providing a list of patients. And some customers were given contracts that exempted them from listing patients unless NECC made a specific request.
"We were trying to show regulators we were acting like a pharmacy," Ronzio said.
Under cross examination Ronzio acknowledged that he had no direct dealings with the defendants.
He said he saw Thomas only once or twice during her short stint at NECC.
Also testifying for the prosecution were two other former NECC employees, Linda Carvalho and Leliz (cq) Cedrone. Carvalho said she knew from past experience that patient specific prescriptions were required and that all prescriptions needed to be verified by a licensed pharmacist before they could be issued.
Nonetheless she said that later in her time at NECC there were a lot of orders that didn't have names.
"Barry gave instructions to ship without names," she said. "We knew they were fake," she said in describing some of the patient lists provided by customers.
Carvalho acknowledged she never worked with Kathy Chin.
Cedrone said some orders would come in with the name of a prescribing physician listed as the patient. She said there were concerns about the obviously fake names and in some cases she would ask company sales staffers to go back to the customer and request "appropriate names."
Kathy Chin and Thomas were the ones to give prescriptions a final check before they were shipped out, she testified. She said that on occasion Thomas had expressed concerns about the way NECC operated but no changes resulted.
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