Mass. Board Let NECC Off With Warnings

By Walter F. Roche Jr.

Boston-The Massachusetts Pharmacy Board got multiple notifications that a drug compounding company it licensed was violating state law but let the firm off with advisory letters that imposed no discipline.
Eight years later that same company was identified as the cause of a deadly outbreak that killed 76 patients. The early warnings were detailed today by a state board official who testified in the trial of six former employees of the New England Compounding Center. They are charged with racketeering and mail fraud, but the state board official reported today that four of the six still have their pharmacist licenses. Another defendant is a registered pharmacy technician.
The sixth defendant, Gregory Conigliaro, was an officer and part owner of the company but was never a licensed pharmacist.
Samuel Penta, supervising investigator for the state pharmacy board, testified that his agency received complaints from three other states that NECC was selling drugs without patient specific prescriptions, a requirement under state law.
Penta said the complaints that NECC was selling prescription drugs out-of -state without prescriptions came in 2004 from pharmacists and health providers in South Dakota, Idaho and Wisconsin.
Penta said the board also learned a year later that NECC was attempting to sell drugs in bulk and without prescriptions to Partners Health, a Massachusetts health care firm.
In yet a fifth instance, a board inspector, after reviewing company records, cited NECC for selling a prescription drug with invalid patient names.
All of the three out-of-state violations were dealt with in a Sept. 21, 2004 meeting of the state board, according to records entered into the court record by federal prosecutors. That meeting came just three months after Sophia Pasedis was named to the pharmacy board.
Pasedis was an officer of Ameridose, another drug company with common ownership with NECC. Her name has surfaced in prior court testimony about an unlicensed pharmacy technician at NECC who was trying to get his state credentials restored.
Massachusetts officials initially stated that Pasedis abstained from any votes involving NECC or Ameridose. They later said some board records were unclear. When the outbreak became public state officials, including then Gov. Deval Patrick, called on Pasedis to resign. She refused and remained on the board until her term expired just weeks later.
Penta, under questioning Wednesday by Assistant U.S. Attorney George Varghese, said NECC had told Partners Health that they could sell up to 5 per cent of their drugs in bulk without prescriptions.
Though some states do have a so-called 5 percent rule, Penta said that was not the case in Massachusetts and individual prescriptions are required. He said he advised Health Partners of that fact.
In other testimony Kristina Donohue, an official of the U.S. Food and Drug Administration recounted her visit to NECC in response to an adverse event complaint registered against the company in 2002. She said that NECC President Barry Cadden was cordial and cooperative the first day she went to the company's Framingham, Mass. offices, but the next day she said Cadden refused to answer questions or provide any documents.
Cadden was convicted of racketeering and mail fraud charges and is now serving a nine year federal prison sentence.
Donohue said that when she returned to NECC a year later, the company had grown from eight to 12 employees. She said that reviews of NECC's operations raised concerns about the sterility of its products. The FDA, however, deferred to the state board for any further action.
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