Regulators Confused as Tragedy Unfolded

By Walter F. Roche Jr.


Boston- Even as the details of a deadly outbreak first began to emerge in Tennessee, regulators at the state and federal level reached out to each other as their lines of authority remained blurred.
In Massachusetts the state's top pharmacy inspector said he knew after just one visit that he needed help and turned to the U.S. Food and Drug Administration. Meanwhile federal officials worried that they lacked authority to move into the state licensed drug compounding company which appeared to be the source of deadly contamination.
That was the scene painted in U.S. District Court today by witnesses for the prosecution in the criminal case against six former employees of that suspect firm, the soon to be infamous New England Compounding Center. The lawyer for one of the defendants, a former vice president and part owner of NECC, Gregory Conigliaro, seized on the indecision, challenging the two witnesses on just what they thought they could do as the tragedy unfolded.
Samuel Penta, the Massachusetts Pharmacy Board's top investigator, said he knew after his initial visit to NECC's Framingham, Mass. headquarters in late September 2012 that he needed help and asked his boss to alert the FDA.
He had gone to NECC following initial reports that a Tennessee patient had been diagnosed with fungal meningitis shortly after injection with a spinal steroid from NECC.
Officials at the federal agency Penta turned to had been struggling for years to determine exactly what authority they had over drug compounders.
Samir Nasn, who headed the FDA unit dealing with drug compounders until her 2011 retirement,
testified just before Penta that due to that confusion it took her agency two years to respond to a filing from NECC.
Confusion about the FDA's authority followed a U.S. Supreme Court decision striking down a drug regulation statute.
Drug compounders, she said, would not even allow FDA regulators to look at their records or even respond to questions.
"They wouldn't allow us in because we didn't have jurisdiction," she told Assistant U.S. Attorney George Varghese
She said complaints about NECC, including the volume of drugs it was producing, had triggered a 2006 warning letter to the firm. NECC responded but it took another two years till October of 2008, for the FDA to respond to NECC's filing.
"It was put on hold till we could figure out what to do next," she said in response to questions from Dan Rabinowitz, Conigliaro's lawyer.
"We had to do what the lawyers tell us," she said, adding that there were also additional complaints against NECC to consider.
Penta, who was on the witness stand for a second day, said that following the initial visit to NECC, his agency, accompanied by FDA inspectors, returned the following week.
Ultimately NECC would surrender its license and the outbreak death toll would reach 76
Penta said he had several immediate concerns on the subsequent visits, including the fact that NECC was shipping out drugs by the hundreds but the company could not produce a single patient specific prescription, a requirement under state law. He said he did not go into the clean room where sterile drugs were prepared but noted from looking in a window that a key piece of equipment did not look right.
"It looked really dirty. It was discolored and didn't look clean," Penta said.
Penta also was asked about a series of contracts NECC had with major Massachusetts health providers which stated that NECC would provide drugs in bulk without requiring prescriptions. Penta said those were all illegal and patient specific prescriptions still were mandatory.
Varghese then presented a series of NECC drug order forms with patient names like Calvin Klein, Donald Trump and Jinny Lopez.
No, Penta responded, they (the order forms)do not comply with state law.
Recounting the October 2012 visit to NECC, Penta said when they looked over the quarantined drugs some had no names or multiple doses for the same patient. Still others listed the doctor and the patient as the same person.
Those, Penta said, did not meet the state requirements.
Penta also described the recycling center, another Conigliaro business located about 100 feet from the drug compounding operation. He said recycled mattresses were piled in the area.
On another NECC visit Penta said they questioned supervisory pharmacist Glenn Chin about his procedures producing the now suspect steroids. He said they determined the steroids were not being treated for long enough in an autoclave to ensure sterility and too few samples were being sent out for testing.
Under questioning by Rabinowitz, Penta acknowledged that at the time of the outbreak, "I was not trained in sterile compounding." His training came after the outbreak.
Nor, Penta acknowledged, did he have the authority to take a drug sample from NECC and have it tested. That was left to the FDA.