The former national sales director for a now-defunct Massachusetts pharmaceutical facility responsible for a deadly fungal meningitis outbreak was sentenced Tuesday in federal court in Boston in connection with conspiring to defraud the Food and Drug Administration.
Prosecutors said the New England Compounding Center fraudulently presented itself as a pharmacy dispensing drugs for physician-created prescriptions, when it actually operated as a manufacturer distributing drugs in bulk. Compounding centers mix customized medications for patients at their required strengths and dosages.
Robert Ronzio, 48, of North Providence, Rhode Island, was sentenced by U.S. District Court Judge Richard Stearns to time served. In 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 defendants from the company.
Mold-tainted steroid injections produced at the center caused the 2012 outbreak, which killed more than 100 people and sickened hundreds. Meningitis is a rare but serious disease that causes swelling of the membranes around the spinal cord and brain. The NECC's contaminated medical steroid injections were given mostly to people with back pain.
The company created what investigators called “work around” methods to make it appear to federal and state regulators that it was dispensing drugs that followed valid patient-specific prescriptions, when it really wasn’t, prosecutors said.
Ronzio admitted the reason for the work-around methods was to maintain the compounding center's status as a pharmacy and avoid heightened regulatory oversight by the FDA, prosecutors said.
In December 2014, following a two-year investigation, Ronzio and 13 other owners, employees, and associates of the company were charged in a 131-count indictment.
The indictment did not charge Ronzio with having any role in the drug manufacturing operations.
Glenn Chin, the former supervisory pharmacist for the company, was resentenced to 10 1/2 years in prison last year after the 1st U.S. Circuit Court of Appeals threw out his eight-year punishment and ordered Stearns to reconsider the case.
The same judge last year added more than five years to the sentence for Barry Cadden, the compounding center's former owner. Cadden was resentenced to 14 1/2 years in prison.