FDA Asserts Authority on Masquerading Compounder

By Walter F. Roche Jr.

Boston- A top official of the U.S. Food and Drug Administration testified today that the company blamed for a deadly fungal meningitis outbreak was masquerading as a pharmacy and her agency clearly did have the authority in 2012 to take action against it.
Janet Woodcock, an FDA director, was testifying in the criminal case against six former employees of the New England Compounding Center. Under lengthy cross examination by the attorney for one of the defendants, Woodcock acknowledged there was some confusion at the time about the FDA's authority over state licensed pharmacies and new legislation was needed. But she said the FDA always had the authority to inspect companies like NECC.
"The FDA always had the authority to inspect," said Woodcock, who is the director of FDA's Center for Drug Evaluation and Research. "We always have had that authority."
Woodcock was confronted with videotapes of her and her boss's testimony before congressional committees in 2013 following the outbreak which sickened nearly 800 patients and killing 76 of them.
Woodcock said that when she and her then boss-Margaret Hamburg told Congress that the FDA had limited authority "we didn't mean that we had no authority."
Dan Rabinovitz, representing Gregory Conigliaro, an NECC vice president and part owner, peppered Woodcock with questions about the FDA's interaction with NECC dating back more than a decade including meetings between state and federal regulators in which the FDA ceded primary authority to the Massachusetts Board of Pharmacy.
Conigliaro is charged with conspiring to defraud the FDA by portraying NECC as a state licensed drug compounder when it was in fact a drug manufacturer.
Woodcock acknowledged that developments in the drug industry had left many hospitals dependent on large drug compounders. She said the FDA was reluctant to initiate vigorous enforcement because hospitals that had come to rely on compounders "would not have been able to respond. We would have created patient harm," she said.
Rabonovitz questioning finally brought a response from U.S. District Judge Richard G. Stearns who said the attorney had asked the same question three times.
"I know it's fun" Stearns said later in reference to Rabinovitz questions,"Can we wrap it up?"
Rabinovitz charged that FDA inspectors used standards that had yet to be put in place when they entered NECC in October of 2012.
Woodcock said the inspection report was not a final determination. He also asked her where she first heard the word "masquerading" in connection with NECC
She said that NECC, as a state licensed pharmacy, was required to have an individual patient specific prescription for every dose of a drug shipped by the company. Prosecutors already have presented evidence that patient lists maintained by NECC included numerous examples of fake names.
At another point Rabinovitz quizzed Woodcock about the differing appeals court rulings on the FDA's authority under a 1997 law.
"Even I don't know that," Stearns interjected, bringing laughter from the jury.
Returning to the witness stand was FDA inspector Stacey Degarmo, one of the agency officials sent to NECC's offices when the outbreak began. She said company records showed drug products were not being sterilized properly because they were not left in an autoclave for the required time.
After the jury had been dismissed for the day, Stearns told lawyers that one juror already was being discharged for personal reasons and another was likely to be discharged next week. As he did last week, Stearns expressed concern that the the case would have a final outcome. Opening arguments began in mid-October.
He asked both sides to consider whether they would agree to proceed with the case if the jury was reduced to less than 12. Fifteen jurors were originally picked to hear the case.
Additional testimony is scheduled for Tuesday but then the jury will not meet for the rest of the week, Stearns has informed both sides. The six are among 14 indicted in 2014 following a two year federal grand jury probe of the outbreak.