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Sharon Carter, Defrauding FDA, Massachusetts 2023

BOSTON – A former pharmaceutical executive has been held accountable for her role in the devastating 2012 meningitis outbreak that killed over 100 patients and affected hundreds more in 20 states.

Sharon Carter, 58, of Hopkinton, was sentenced to five months in prison and one year of supervised release for conspiring to defraud the Food and Drug Administration (FDA).

On December 2018, Carter was convicted following an eight-week jury trial of conspiracy to defraud the United States. In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections manufactured by New England Compounding Center (NECC) that were contaminated with preservative-free methylprednisolone acetate (MPA).

The outbreak was the largest public health crisis ever caused by a contaminated pharmaceutical drug. Carter was the former Director of Operations of NECC.

‘One may think that making misrepresentations or lying to federal regulators is a victimless crime. This case proves otherwise,’ said United States Attorney Rachael S. Rollins. ‘In her role as Director of Operations, Ms. Carter conspired to deceive regulators into treating NECC as a lawfully operating pharmacy.’

‘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.’

Carter was also ordered to pay a fine of $4,000.

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 legitimate medications.

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