Missouri Officlals Found NECC in Violation

By Walter F. Roche Jr.

A former official of the Missouri Board of Pharmacy agreed today that he told a federal prosecutor in 2012 he believed the Massachusetts Pharmacy Board "dropped the ball" when it failed to act against the drug compounding firm eventually blamed for a 2012 deadly outbreak.
The former official, Kevin Kinkade and an other Missouri pharmacy official, also testified that an investigator from his agency had concluded years before the outbreak that that the New England Compounding Center was shipping drugs into that state in violation of a requirement that there be a patient a patient specific prescription for each dose of drugs shipped.
Kinkade, his successor and the Missouri board investigator, recounted a long battle with the New England Compounding Center that appeared to be near a compromise seven years ago. But the now defunct company ultimately let its Missouri license lapse and the compromise was never implemented. That was on Oct. 31, 2011, just a year before the deadly outbreak surfaced in Tennessee.
The testimony came in U.S. District Court on the 21st day in the trial of six former NECC employees including it's vice president and part owner, Gregory Conigliaro, who was heavily involved in the Missouri negotiations. The fungal meningitis outbreak first detected in Tennessee killed at least 76 patients across the country among nearly 800 who were sickened
According to the Missouri officials Conigliaro himself traveled to their state for a negotiation session with board officials. Though an apparent compromise was later reached, it was never implemented before NECC's Missouri license expired in the Fall of 2011.
Conigliaro, NECC's vice president, is facing a single charge of conspiracy to defraud the U.S. Food and Drug Administration by portraying to state and federal regulators that NECC was simply a Massachusetts licensed pharmacy and not subject to stricter FDA requirements.
It was under cross examination by Conigliaro's lawyer, Dan Rabinovitz, that Kinkade acknowledged he told Assistant U.S. Attorney George Varghese during the outbreak investigation and prior to any indictments that he thought the Mass. pharmacy board"dropped the ball" by not taking action against NECC earlier.
"It appeared the Massachusetts Board of Pharmacy could have done more," Kinkade said.
Another prosecution witness and the Missouri board's chief investigator, Thomas Glenski, said that a Missouri inspector first learned that NECC might be in violations of the state requirements when he found records at a health facility indicating NECC had shipped prescription drugs to the facility without prescriptions listing the patient who was getting the drug.
He said that a subsequent review of records at other health facilities brought the same conclusion. As a result, he said, the agency was moving toward placing NECC's license on probation.
In negotiations that followed, emails and other records placed in the record showed, Conigliaro sent documents to the Missouri board that raised even more questions. Those records, according to Glenski, showed some of the drugs were shipped only with the name of a health facility. In addition the records showed that even when patients names were listed the number of doses per patient appeared excessive.
He said the records indicated that 12 doses of one drug were prescribed for one patient, all on the same day. Another record obtained by the board showed details for only one patient, but nothing for nine others.
He said NECC contended contractual agreements with hospitals covered the patient specific requirement, but promised copies of the contracts were never provided.
The jury also heard testimony from a hospital pharmacy buyer in Los Angeles who testified that her facility bought multiple doses of methotrexate from NECC, but the hospital was never told the expiration date of the main ingredient in the cancer fighting drug had passed years earlier. She said an NECC salesman assured her the drug "would be safe."
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