Barry Cadden, president of the compounding pharmacy which distributed deadly tainted steroids in 2012, has been jailed for nine years
The outbreak saw hundreds across the United States become ill with fungal meningitis. By the end of October 2013, it was deemed that at least 64 people had died after taking the contaminated drugs; according to CBS Boston, federal prosecutors later raised the total number of fatalities to 76.
In a statement by Food and Drug Administration Commissioner Dr Scott Gottlieb, the outbreak was described this week as “the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product”.
“It was an incident that resulted in dozens of deaths,” he said.
Mr Cadden faced charges of second-degree murder over the outbreak, but was found not guilty on these charges.
However, he was convicted of 57 of the 96 charges he faced, including mail fraud and racketeering. He faced a maximum sentence of 20 years in prison on each of these charges.
The fungal meningitis outbreak related to shipments of preservative-free methylprednisolone acetate (MPA) which was manufactured in unsafe conditions at the New England Compounding Center (NECC) in Framingham, Massachusetts.
“Barry Cadden put profits over patients,” said Acting United States Attorney William D. Weinreb.
“He used NECC to perpetrate a massive fraud that harmed hundreds of people. Mr. Cadden knew that he was running his business dishonestly, but he kept doing it anyway to make sure the payments kept rolling in.”
As well as directing and authorising the shipping of contaminated MPA to NECC customers nationwide, Mr Cadden authorised the shipping of drugs before test results confirming their sterility were returned, did not notify customers of non-sterile results, and compounded drugs with expired ingredients.
Certain batches of drugs were manufactured, in part, by an unlicensed pharmacy technician at NECC.
Mr Cadden also repeatedly took steps 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, the US Attorney’s Office says.
NECC routinely dispensed drugs in bulk without valid prescriptions and even used fictional and celebrity names on fake prescriptions to dispense drugs, such as “Michael Jackson,” “Freddie Mae” and “Diana Ross.”
According to the Boston Globe, Mr Cadden read a statement to victims in which he said he would carry the burden of his actions for life.
“I am so sorry for your extraordinary loss,” he reportedly said.
Victims had hoped for a longer custodial sentence and prosecutors had asked for Mr Cadden to be imprisoned for at least three decades.
One meningitis sufferer said she would die as a result of the outbreak and hoped to survive for two more years. US District Judge Richard Stearns told the Court that he had read more than 600 pages of victim impact statements.
Mr Cadden’s defense, which pointed out that he had been found not guilty of second-degree murder, had asked for three years in prison.
Several other NECC workers are facing charges.
Meanwhile, the FDA’s Mr Gottlieb said that the fungal meningitis outbreak underscored the need for robust oversight over human drug compounding, the importance of dispensing prescription drugs pursuant to valid prescriptions and the need for strong coordination with state regulatory partners to protect public health.
He highlighted the fact that the FDA had devoted “significant resources” to oversee compounding and implement the compounding provisions of the law.