Thursday, February 23, 2017
FDA: NECC Steroids Not Properly Sterilized
By Walter F. Roche Jr.
BOSTON, Mass.-An investigator from the U.S Food and Drug Administration testified today that the fungus ridden steroids shipped from a now defunct compounding firm had been sterilized for less than half the recommended time.
Testifying in U.S. District Court Stacey Degarmo said that records she reviewed at the New England Compounding Center in 2012 showed the steroids were placed in an autoclave for only 15 minutes. She said with the volume of drugs being treated the manual for the autoclave called for 31 minutes in autoclave.
She said NECC didn't even follow its own instructions, which called for 20 minutes inside the autoclave at a temperature of 121 degrees.
Degarmo, the lead FDA investigator assigned to the 2012 fungal meningitis outbreak was testifying for the prosecution in the second degree murder trial of Barry J. Cadden. He was one of 14 people connected to NECC who were charged in a 2014 indictment.
The indictment followed a two year probe of the 2012 fungal meningitis outbreak, which sickened 778 patients, killing 78 of them.
The FDA investigator said she asked NECC for validation that a 15 minute treatment in the autoclave was adequate but she never got a response. She said her review of NECC records showed that the practice of sterilizing the steroid, methylprednisolone acetate, for only 15 minutes dated back to 2009.
Another problem area, she said, was the fact that NECC was testing its steroids in bulk, not the individual vials later shipped to health care providers. She said the records showed NECC had shipped out vials before the sterility tests came back.
Degarmo said that one of the first things she noticed when she got to NECC was a big pile of deteriorating mattresses piled up near the building. She said heavy equipment was being operated in the area creating a cloud of dust and particulates.
"All this was flying around," she said.
She said that set of "red flags" because she had learned that one of the seven outbreak victims in Nashville, Tenn. had been diagnosed with aspergillus fumagatus, which grows in the soil.
Degarmo said that she also performed environmental sampling tests when she arrived at NECC's Framingham, Mass. facility on Oct. 1, 2012.
She said 11 of 41 samples tested positive for mold, bacteria or both. Yeast was also detected in key areas including the air conditioning and heating unit atop the brick structure.
The 11 positive findings for mold or bacteria included specimens from a pass through from the clean room to the warehouse or packing area, inside the glove of a glove box used to prepare sterile drugs, on a mat at the entrance to the clean room and around a boiler sitting in a pool of leaking water.
The FDA investigator said she also learned that when NECC prepared lots of the steroid only one sample was sent out to an independent laboratory to test for sterility. She called that "inadequate."
Under questioning by Assistant U.S. Attorney George Varghese, Degarmo said that when they examined vials of the steroid that had not been shipped out before a quarantine was imposed some had "clearly visible black mold."
She said 12 of 45 vials examined had visible mold.
At that point in time, she testified Cadden "still didn't believe there was a problem with the NECC product."
She also said she got conflicting information when she asked Cadden if NECC was compounding the drugs from sterile or non-sterile components.
Under cross examination by Bruce Singal, Cadden's lead attorney, Degarmo was questioned repeatedly about why the agency waited several days after learning about the outbreak before sending a team to NECC.
Citing internal FDA emails and documents, Singal asked why the FDA was worried about whether it had the legal authority to join an investigation already begun by the Massachusetts Board of Pharmacy.
Degarmo said she was aware that the FDA's authority over compounding pharmacies had been challenged in the past, but it was not a major factor. She said the agency clearly had the authority to investigate any cases involving adulterated drugs.
She said her team accompanied the team from the Mass. Pharmacy Board on the initial inspection because that agency had clearer authority to order NECC to produce records in the event the company refused to do so.
Singal, however, noted that FDA still hadn't acted even after it learned that seven patients in Nashville, Tenn. had been stricken with an additional case reported in North Carolina.