Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
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Food and Drug Administration and Compliance Issues
Wednesday, February 9, 2022
Tuesday, February 8, 2022 Defendant admitted NECC created fraudulent prescriptions to avoid federal oversight
Department of Justice
U.S. Attorney’s Office District of Massachusetts
FOR IMMEDIATE RELEASE Tuesday, February 8, 2022
Defendant admitted NECC created fraudulent prescriptions to avoid federal oversight
BOSTON – The National Sales Director of the now-defunct New England Compounding Center (NECC) was sentenced today in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration (FDA).
Robert A. Ronzio, 48, of North Providence, R.I., was sentenced by U.S. District Court Judge Richard G. Stearns to time served. In December 2016, Ronzio pleaded guilty to one count of conspiring to defraud the FDA. Ronzio cooperated with the government and testified at three trials of other NECC defendants.
NECC fraudulently held itself out as 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, NECC sales representatives requested that customers (hospitals and clinics) 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. 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, the former owner of NECC and head pharmacist, Barry Cadden, created ratios of patient names to the number of drug units sought in an order. Ronzio admitted that 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. In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of MPA manufactured by NECC, and more than 100 patients died as a result. The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug.
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 any role in the drug manufacturing operations of NECC.
On July 7, 2021, Cadden was resentenced, following the government’s successful appeal of his original sentence, to 174 months in prison and ordered to pay forfeiture of $1.4 million and restitution of $82 million. On July 21, 2021, Chin was resentenced, following the government’s successful appeal of his original sentence, to 126 months in prison and three years of supervised release. Chin was also ordered to pay forfeiture of approximately $473,584 and restitution in the amount of $82 million.
United States Attorney Rachael S. Rollins; Acting FDA Commissioner Janet Woodcock, M.D.; Jeffrey Ebersole, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division; Christopher Algieri, Special Agent in Charge of the Department of Veterans Affairs, Office of Inspector General, Northeast Field Office; Patrick Hegarty, Special Agent in Charge of the Defense Criminal Investigative Service, Northeast Field Office; and Ketty Larco-Ward, Inspector in Charge of the U.S. Postal Inspection Service’s Boston Division, made the announcement today. Assistant U.S. Attorney Amanda P.M. Strachan, Deputy Chief of Rollins’ Criminal Division, prosecuted the case.
Topic(s): Health Care Fraud Component(s): USAO - Massachusetts