The owner and co-founder of the New England Compounding Center, the pharmacy at the center of a deadly fungal meningitis outbreak, declined to testify before a congressional hearing today.
When pressed by members of Congress on his role in ensuring safe and sterile products, Barry Cadden invoked his Fifth Amendment right.
"On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States," he said at the hearing in Washington, D.C.
The House of Representatives had subpoenaed Cadden to the hearing to address the outbreak that has sickened 461 people in 19 states and killed 32. The outbreak has been traced to contaminated vials of methylprednisolone acetate, an injectable steroid used to treat back and joint pain made by Cadden's pharmacy.
But the Subcommittee on Oversight and Investigations panel became clearly frustrated with the testimony of U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg.
Republicans lawmakers noted inspections of NECC going back to 2002 that found sterility issues at the facility, and asked why the FDA had not taken action against the pharmacy.
"You are in charge of the FDA. You are the chief honcho. You're the great Pooh-Bah of the FDA and I'm asking you, basically, could you have prevented this tragedy? And you are saying you can't because you didn't have jurisdiction?" said Rep. Cliff Stearns, R-Fla.
"I think it is very hard to know if any one action that we might have taken could have stopped this terrible tragedy," Hamburg replied, adding that in her opinion, the FDA did nothing wrong.
The commissioner told the panel that her agency needed stronger authority over "compounding" pharmacies.
"The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," said Hamburg. She said there were "gaps" and "ambiguity" in the FDA's authority, and described a "crazy quilt" of laws.
Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. NECC, however, acted more like a manufacturer by filling thousands of prescriptions and shipping across state lines causing confusion in the FDA's jurisdiction.
Republicans were visibly irritated at Hamburg's lengthy responses to their yes or no questions, at certain points even chastising the FDA commissioner for her responses.
"Can you ever give straight answer to a question?" Rep. Joe Barton, R-Texas, asked, while Stearns reminded Hamburg that she was under oath.
Joyce Lovelace spoke about her husband Eddie, who died from fungal meningitis in September after receiving a tainted steroid injection, saying she wanted "people to know what kind of person has perished because of their lack of concern."
"My family is bitter. We are angry. We are heartbroken. We're devastated and I just come here begging you to do something about the matter," she said. "It was a nightmare to see this man who was perfectly healthy one moment and then just so quickly going downhill and everything the doctors were doing for him was to no avail. The medicine, whatever they did, it was not helping him in the least."
Lovelace begged the committee to "legislate this."
"Whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life, cost my family… It may not appear to be anything to you, but you are affecting valuable human lives," she said. "I cannot beg you enough. Bi-partisan. I don't care what party, work together and please legislate this so no family has to go through what we have."
The Associated Press contributed to this story.