She absolved the FDA of responsibility for the outbreak, which has killed 32 people and caused 461 infections in the past three months. The agency learned of contamination problems at the New England Compounding Center (NECC), in Framingham, Mass., in 2002 and had been in periodic contact with the company since then.
“We have no reason to believe that any of the specific actions in question . . . would have prevented this recent tragedy,” Hamburg said.
Members of the committee disagreed. For three hours they grilled her, trying to elicit “yes” or “no” answers about the FDA’s authority and talking over her long answers. Republican members in particular came down hard on the FDA’s failure to be a more aggressive regulatory agency — a stance whose irony wasn’t lost on one of their Democratic colleagues.
“For years they’ve been talking about job-destroying regulation, let industry police itself, and we don’t want more government involvement,” said Henry A. Waxman (D-Calif.). “And now they’re saying they want more government involvement — and I think they’re right.”
Michael C. Burgess (R-Tex.), who is a physician, said the FDA already has authority to shut down compounding pharmacies doing illegal activities. He cited the agency’s 2006 warning letter to the NECC’s owner that “failure to promptly correct” several practices (none involving contamination) could result in “seizure or injunction.”
As Hamburg tried to explain why she doesn’t believe that the FDA’s authority is clear, Burgess said: “We’re just not buying it.”
Sitting next to the FDA commissioner was Lauren Smith, the interim commissioner of the Massachusetts Department of Health, which oversees the state’s Board of Registration in Pharmacy. She said her agency shares the blame.
“NECC bears the responsibility for the harms that its actions have caused, but the board of pharmacy’s failure to take decisive action in 2006 has contributed,” she said.
Neither Smith nor Hamburg were in their jobs when the original inspections of NECC occurred and an FDA warning letter was sent in 2006.
The first witness in Wednesday’s hearing was Joyce Lovelace, the widow of Eddie C. Lovelace, 78, a judge in Kentucky who died Sept. 17 of what was first thought to be a stroke but turned out to be fungal meningitis. He had received three injections of steroids to relieve back pain from a car accident in March.
Lovelace wore a gray cardigan and spoke from a wheelchair pulled up to the witness table. “It was not an easy death that we witnessed,” she told the legislators. Of the state and federal regulators and inspectors, she said: “I want them to know how their lack of attention to their duties cost my husband his life.”