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BOSTON – The former Director of Operations of the now-defunct New England Compounding Center (NECC) in Framingham was sentenced yesterday, December 13, in federal court in Boston for conspiring to defraud the Food and Drug Administration (FDA).
In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections manufactured by NECC that were contaminated with preservative-free methylprednisolone acetate (MPA), and more than 100 patients died as a result.
The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug.
Sharon Carter, 58, of Hopkinton, was sentenced by U.S. District Court Judge Richard G. Stearns to five months in prison and one year of supervised release. Carter was also ordered to pay a fine of $4,000. In December 2018, Carter was convicted following an eight-week jury trial of conspiracy to defraud the United States.
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“One may think that making misrepresentations or lying to federal regulators is a victimless crime. This case proves otherwise. In her role as Director of Operations, Ms. Carter conspired to deceive regulators into treating NECC as a lawfully operating pharmacy,” said United States Attorney Rachael S. Rollins. “The victims in this case – all trusting, innocent people – were simply seeking pain relief. Instead, those who survived were sentenced to a lifetime of anguish and trauma. This sentence speaks to my office’s ongoing commitment to the safety and protection of our residents in all areas of life and ensuring those who seek to do harm are held accountable.”
“As NECC’s director of operations, Sharon Carter conspired with her colleagues to lie to federal regulators to perpetrate a massive fraud scheme that harmed hundreds of people across the country whose lives will never be the same. Our thoughts are with them as Ms. Carter is finally held responsible for her role in one of the worst public health crises in U.S. history,” said Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “While she now heads to prison, rest assured the FBI, and our law enforcement partners will continue to work to bring others who like her, violate the law and put patients at risk to justice.”
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“FDA depends upon truthful representations from regulated firms, especially in the area of high-risk drug compounding, in order to help protect consumers from potentially unsafe products,” said Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office. “We are grateful that those at NECC who violated this essential principle, including Ms. Carter, have been brought to justice.”
“Our nation’s veterans deserve the highest quality healthcare services, and this sentence demonstrates the VA OIG’s commitment to diligently investigating any potential criminal activity that could threaten the safety of VA’s patients,” said Special Agent in Charge Christopher Algieri with the Department of Veterans Affairs Office of Inspector General’s Northeast Field Office. “The VA OIG appreciates the support of the United States Attorney’s Office and our law enforcement partners for their efforts to achieve justice in this case.”
“This case demonstrates the commitment of the U.S. Postal Inspection Service to the safety and health of the American public,” said Ketty Larco-Ward, Inspector in Charge of the U.S. Postal Inspection Service, Boston Division. “The U.S. Postal Inspection Service, along with our federal law enforcement partners, will continue to investigate and take action against those who take part in this type of atrocious behavior.”
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The criminal investigation revealed that NECC pharmacists knowingly made and sold numerous drugs in an unsafe manner and in insanitary conditions. The investigation also revealed that NECC repeatedly misrepresented to the FDA and the Massachusetts Board of Registration in Pharmacy that NECC was operating as a pharmacy dispensing drugs only pursuant to patient-specific prescriptions, when, in reality, NECC was shipping drugs in bulk across the nation for over a decade, evading regulatory oversight through fraud and misrepresentation.
As Director of Operations, Carter oversaw the processing and confirmation of drug orders received by NECC. Carter conspired with others to shield NECC’s operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. Carter directed employees to engage in numerous fraudulent prescription schemes to deceive regulators by creating the appearance that NECC had prescriptions for the drugs it was selling.
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Barry Cadden, former co-owner of NECC and head pharmacist, and Glenn Chin, NECC’s supervisory pharmacist, were both resentenced following the government’s successful appeals of their original sentences. On July 7, 2021, Cadden was resentenced to 174 months in prison and ordered to pay forfeiture of $1.4 million and restitution of $82 million. On July 21, 2021, Chin, NECC’s supervisory pharmacist, was resentenced 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.
U.S. Attorney Rollins; FDA Commissioner Robert M. Califf, M.D.; FBI SAC Bonavolonta; FDA SAC McMillan; VA OIG SAC Algieri; DCI SAC Hegarty; and USPIS INC Larco-Ward made the announcement. Assistant U.S. Attorney Amanda P.M. Strachan, Chief of Rollins’ Criminal Division and Assistant U.S. Attorney Christopher R. Looney of Rollins’ Health Care Fraud Unit prosecuted the case.
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MetroWest Medical Center