House panel grills FDA about compounding pharmacies

November 14, 2012

The head of the Food and Drug Administration said Wednesday the agency needs new authority over compounding pharmacies in order to prevent disasters like the ongoing outbreak of meningitis linked to tainted custom-made drugs.

The current system in which state and federal agencies share oversight — and courts disagree on their lines of authority — has “hampered our ability to act to protect patients and prevent, rather than just react to, safety concerns,” Commissioner Margaret A. Hamburg told members of the House Energy and Commerce subcommittee on oversight and investigations.

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.”

Lovelace said she learned from a reporter for a Nashville newspaper that public health officials suspected her husband’s death had been caused by contaminated medicine. She was not notified by the Centers for Disease Control and Prevention, the FDA or the state health department, all of which were investigating.

After Lovelace was excused, the co-owner and chief pharmacist for NECC, Barry J. Cadden, who’d been subpoenaed by the committee, walked in. He had two lawyers with him.

Cadden wore a dark suit, a gray-and-black regimental striped tie and had a brush cut. Photographers sitting on the floor in front of the witness table formed a cordon of lenses and cameras feet from his face. He fingered an index card and repeatedly read from it a statement invoking his Fifth Amendment right against self-incrimination and declined to answer questions.

Reps. Cliff Stearns (R-Fla.) and Diana DeGette (D-Colo.) were unsuccessful in getting him to say more and he was dismissed.

One issue Hamburg was queried about repeatedly was evidence that the NECC made drugs in large quantities and not just in response to patient-specific prescriptions, which is the traditional basis of compounding. That activity appears to be manufacturing, which is regulated by the FDA. The agency warned compounding pharmacies against it, but didn’t appear to have tried to shut them down.

“Your agency did not use your power to define who is a manufacturer,” Rep. John D. Dingell (D-Mich.) told Hamburg.

When the FDA commissioner began once again to talk about the ambiguity of “the current regulatory framework,” Dingell interrupted her and warned, “You are putting your head in a noose.”

Hamburg said legislation is needed that would allow the FDA to routinely inspect “non-traditional” compounding pharmacies, hold them to higher production standards and see records about the volume of drugs being made, as well as require compounders to report adverse events associated with their products.

Rep. Edward J. Markey (D-Mass.), who represents the district in which the NECC is located, has introduced legislation that would address many of the things proposed by Hamburg.

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