By Walter F. Roche Jr.
A federal prosecutor told an appeals court panel today that not only was it possible for officials of a drug company to defraud the U.S. Food and Drug Administration in fact they succeeded.
"The conspiracy was successful,"U.S. Justice Department attorney Ross Goldman argued in a nearly one hour hearing in federal court in Boston, Mass.
Goldman was asking a three judge panel to reverse the decision of U.S. District Court Judge Richard G. Stearns who overturned unanimous guilty jury verdicts and dismissed the conspiracy charges against Gregory Conigliaro and Sharon Carter.
Conigliaro was vice president and part owner of the now defunct New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak. Carter was NECC's director of operations.
Daniel Rabinowitz, Conigliaro's lawyer, stated that it was a legal impossibility for his client to defraud the FDA because the agency had effectively abdicated its authority over drug compounding firms like NECC.
Citing trial testimony Rabinowitz said the FDA had gone years and years without taking action against drug compounders.
He noted that when Colorado regulators raised questiona about NECC shipping drugs without patient specific prescriptions, the FDA deferred the matter to Massachusetts regulators.
Michael Pinneault, representing Carter,said internal uncertainty within the FDA about the legal authority over drug compounders led agency officials to stand down.
"The FDA was well aware of what was going on," Pinneault stated, adding that there was no evidence Carter had any interaction with federal regulators.
She had involvement "in every aspect" of the operation, Goldman reponded. He noted two top FDA officials testified that the agency had the authority over NECC all along.
Judge Kermit Lipez, questioned Pinneault about an FDA guidance on the agency's authority over drug compounder which he said seemed "very clear."
Carter and Conigliaro were among 14 persons connected to NECC who were indicted in 2014 following a two year investigation of the 2012 fungal meningitis outbreak, which ultimately took the lives of more than 100 patients.
NECC shipped thousands of vials of fungus riddled steroids to health providers across the country.
Contact: wfrochejr999@gmail.com
I think the whole wrongdoing came down to what AGAIN was stated: The judge overturned what the jury found. We'll see what the next step is!
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