WASHINGTON, D.C. -- The president of the New England Compounding Center (NECC) will be called to testify on Capitol Hill Wednesday about the deadly meningitis outbreak linked to contaminated steroid shots distributed by the company.
I have a right to say there's a debacle here. There's malfeasance. Somebody's culpable," says Rep. Cliff Stearns, R-Fla., who chairs the House Energy and Commerce subcommittee that is investigating the outbreak. "Come to me and explain why 32 Americans have died, 450 are in the hospital. Tell me what happened."
Stearns says he expects NECC president Barry Cadden to remain silent and take the Fifth Amendment.
More than 400 patients in 19 states have been diagnosed with meningitis. Meanwhile, federal investigators found insects, birds and leaky ceilings at a second drug manufacturer that is linked to the NECC.
"There was clear evidence that the quality control was terrible at the New England Compounding Center and he was doing nothing about it," Rep. Stearns says of NECC president Cadden. "So for some reason, he was camouflaging and trying to indicate to the FDA that there was no problem. ... I think obviously he was shading the truth."
Stearns plans to examine an incident in September 2004 when Cadden was asked by an FDA investigator if NECC had "Trypan Blue" -- a product that is not approved by the FDA -- in stock. Cadden said it did not, according to the investigator, who then reported finding 189 vials of it on site.
"So I think the FDA has a lot to explain here, because at this point all of us are just aghast at the number of people that have died, as well as a huge number of people who ended up in hospitals," Stearns says.
Strearns says he plans to question FDA Commissioner Dr. Margaret Hamburg about why the agency dropped investigations into the "Trypan Blue" incident and another incident two years before, when at least two people developed septic shock after being injected with a drug made by NECC.
The NECC did not respond to a request for comment Tuesday. The FDA released a statement saying that it needs to have its authority strengthened and is looking forward to working with Congress to make sure this never happens again.
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