NECC Drugs Verified Before Sterilization

By Walter F. Roche Jr.,

BOSTON- A U.S. Food and Drug Administration official said today the company responsible for a nationwide outbreak certified its drugs were sterile before they had been sterilized.
Testifying in U.S. District Court as a prosecution witness Stacey Degarmo, the lead FDA investigator in the probe of the 2012 outbreak said Glenn Chin's verification of the steroid blamed for the outbreak was dated a day before records show the drug was placed in an autoclave to ensure sterility.
The statement came in the 14th day of the trial of Chin, who was a supervising pharmacist at the now defunct New England Compounding Center. Chin is facing racketeering, second degree murder and mail fraud charges.
U.S. District Judge Richard G. Stearns disclosed at the end of the Friday session that the trial was running some three weeks ahead of schedule and the case could be going to the jury the week after next. That would be in sharp contrast to the 10-week trial of co-defendant Barry J. Cadden, who already is serving a nine year prison sentence,
Cadden, who was NECC's president and part owner, was convicted of racketeering and mail fraud, but cleared of second degree murder charges.
Degarmo also testified at length about NECC's use of an autoclave, in violation of its own standard operating procedures. She said Chin, who was in charge of the clean room where the methylprednisolone acetate was compounded, told her the drug was sterilized in large beakers for only 15 minutes instead of the 20 minutes listed in the company records.
She said Chin told her NECC changed to 15 minutes after the purchase of a new autoclave. Degarmo said that changing the autoclave would not justify a reduced treatment time.
In addition she said NECC failed to include the time needed to being the large beakers of steroid to the the desired temperature. She estimated that as a result the beakers may only have been sterilized at the proper temperature for four minutes.
She also said Chin acknowledged NECC was not using biological indicators to assure sterilization had been achieved
In other testimony, Samuel Penta of the Massachusetts Board of Pharmacy described how surprised he was to see the size and scope of NECC's operations. He said it was nothing like anything he had seen at any drug compounder licensed by the state.
Stating that they knew they would need help, Penta said the state board turned to the FDA and agents for both agencies began a series of visits to the Framingham, Mass. facility.
Penta acknowledged there was confusion as the outbreak developed in late September 2012 over whether state or federal officials had jurisdiction.
The 2012 outbreak sickened some 778 patients in 20 states. Seventy-six died.
Testimony continues Tuesday.
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