News - New England Compounding Center’s National Sales Director Pleads Guilty
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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.
Foley & Small is representing more than 90 persons or their Estates who were injured or died from receiving a contaminated epidural injection manufactured by NECC. Resolution of the claims against NECC is underway as part of the NECC bankruptcy proceedings, with more than $120 million to be distributed to claimants. Foley & Small is also pursuing claims against OSMC in Elkhart and the South Bend Clinic, which selected NECC as a supplier despite NECC operating illegally under state and federal law. It is alleged that the state clinics acted complicitly with NECC to avoid FDA safety standards and the requirements of state and federal law regarding patient prescriptions and prohibitions against bulk drug sales. The plea agreement by Ronzio will prove helpful in prosecuting the claims against the state clinics.