Defendant admits NECC created fraudulent prescriptions to avoid federal oversight
BOSTON – The National Sales Director for New England Compounding Center (NECC), a compounding pharmacy located in Framingham, Mass., pleaded guilty yesterday in U.S. District Court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA).
Robert A. Ronzio, 42, of North Providence, R.I., pleaded guilty to one count of conspiring to defraud the FDA. U.S. District Court Judge Richard G. Stearns scheduled sentencing for Sept. 27, 2017. Ronzio is cooperating with the government and is expected to testify at the trials of the other NECC defendants.
Ronzio admitted that NECC was a pharmacy dispensing drugs pursuant to physician-created prescriptions when in fact it operated as a manufacturer distributing drugs in bulk. NECC created numerous work-around methods to make it appear to federal and state regulators that NECC was dispensing drugs pursuant to valid patient-specific prescriptions when in fact it was not.
Specifically, Ronzio admitted that NECC sales representatives requested that customers send in a list of patient names with their orders, but informed the customers that NECC would not label the drugs with the names of patients, thereby allowing the customers to use the drugs for any patients. Ronzio further admitted that NECC sales representatives requested customers send patient rosters or appointment schedules with their orders, from which NECC employees created patient-specific prescriptions that could be provided to federal or state regulators. Furthermore, NECC would not request patient names for first orders, and often waived the requirement entirely for certain customers or drug orders. To determine the number of patient names required, NECC owner and head pharmacist Barry J. Cadden is alleged to have created ratios of patient names to the number of drug units sought in an order. Cadden explained to Ronzio, “The MAX total number of units (vials, syringes, etc..) per patient must make sense. I must be able to logically explain to a regulator why we processed x# of units per patient.” Ronzio admitted the reason for these work-around methods was to maintain NECC’s status as a pharmacy and avoid heightened regulatory oversight of the FDA.
The NECC criminal case arose from the nationwide outbreak of fungal meningitis that was traced back to contaminated vials of preservative-free methylprednisolone acetate (MPA) manufactured by NECC. The outbreak was the largest public health crisis caused by a pharmaceutical product. The Centers for Disease Control and Prevention reported that 751 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 751 patients, the CDC reported that 64 patients in nine states died. The government’s investigation has revealed that those numbers continue to rise.
In December 2014, following a two-year investigation, Ronzio and 13 other owners, employees, and associates of NECC were charged in a 131-count indictment. The indictment did not charge Ronzio with having an active role in the drug manufacturing operations of NECC, but did charge him with conspiring to defraud the FDA.
Cadden and supervisory pharmacist Glenn A. Chin were charged with 25 racketeering acts of second-degree murder in seven states. Eleven other defendants, including six pharmacists, the director of operations, an unlicensed pharmacy technician, and three other owners and executives were charged with additional crimes including racketeering, mail fraud, conspiracy, violations of the Food, Drug and Cosmetic Act, and structuring. Cadden is scheduled to stand trial on Jan. 5, 2017.
United States Attorney Carmen M. Ortiz; Jeffrey Ebersole, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Donna Neves, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Northeast Field Office; Craig Rupert, Special Agent in Charge of the U.S. Department of Defense, Office of Inspector General, Defense Criminal Investigative Service, Northeast Field Office; and Shelly Binkowski, Inspector in Charge of the U.S. Postal Inspection Service, made the announcement today. Assistant U.S. Attorneys George P. Varghese and Amanda P.M. Strachan of Ortiz’s Health Care Fraud Unit and John W.M. Claud of the Justice Department’s Consumer Protection Branch are prosecuting the case.
The details contained in the Indictment are allegations. The defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt.