View attachment 29856 Representative John D. Dingell, Democrat of Michigan, thumped his desk in exasperation as he questioned Dr. Margaret A. Hamburg, the Food and Drug Administration commissioner, during last week’s Congressional hearing on the meningitis outbreak caused by a tainted drug. Other lawmakers had already accused Dr. Hamburg of evading their questions.
If she kept being defensive, Mr. Dingell warned, “I would assure you that you are putting your head in the noose.”
Hearings like this may be partly theater, a chance for politicians to strut their righteous indignation and threaten tough new laws. But a public health disaster had occurred on Dr. Hamburg’s watch, one about which she has been mostly silent, and the hearing was a chance for her to show leadership and mastery. Instead, her answers were vague and long-winded, and it was clear by the reactions of the panel members that they brought more frustration than clarity.
The hearing was titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” But the question was never really answered, and hours of testimony left the ominous impression that the country has few safeguards to prevent an outbreak like that from happening again.
Democrats on the committee wanted to quickly pass new legislation to strengthen the F.DA.’s ability to police rogue drug makers, but Republicans seemed less eager. It was not clear whether the hearing would actually accomplish anything.
So far, 33 people have died and 447 others have become ill from injections of a fungus-contaminated steroid drug made by the New England Compounding Center in Framingham, Mass. The number of cases is still rising. Inspections of the drug maker have revealed a stunning array of dangerous practices and unclean equipment, as well as vials of medicine with visible blobs of fungal matter floating in it. The center has been shut down.
Joyce Lovelace, a white-haired woman with a soft voice and a Southern accent, addressed the committee from a wheelchair. She described the illness and death of her husband, Eddie, who at 78 had still been serving as a judge in Kentucky.
View attachment 29859 [Pic: Dr. Margaret A. Hamburg, FDA Commissioner] “It was not an easy death we witnessed,” Mrs. Lovelace said. She added, “These committees, the F.D.A., the N.E.C.C., whoever is responsible, I want them to know their lack of attention to their duties cost my husband his life.”
The next witness was Barry Cadden, the chief pharmacist and an owner of the New England Compounding Center. Flanked by his lawyers, he invoked the right to avoid incriminating himself and did not answer any questions.
Mr. Cadden’s company was shipping a huge array of drugs to clinics and hospitals around the country, including some of the nation’s most prestigious medical centers. The business, which opened in 1998, had several run-ins with the F.D.A. and with health officials in Massachusetts over the years, and pharmacy boards in other states had complained about its practices. But it kept operating.
Dr. Hamburg came in for a grilling because a deadly outbreak from a contaminated drug is exactly the kind of public health tragedy that her agency is meant to prevent.
She used much of her testimony to insist that the agency’s authority over the New England Compounding Center and other companies like it was not clear, and that new laws were required. Currently, she said, companies like New England Compounding could thwart oversight by suing the F.D.A. if it tried to regulate them, and by refusing to allow inspections without search warrants.
But the lawmakers said that existing laws gave the agency all the power it needed, and that it had simply failed to use that power.
“Commissioner, two agencies here have dropped the ball,” Mr. Dingell said, referring to the F.D.A. and the Massachusetts Board of Pharmacy.
The issue is that New England Compounding identified itself as a compounding pharmacy, a practice that is supposed to involve making unusual drug formulations to fill prescriptions for individual patients with special needs. Compounding is legal on a small scale, and does not have to follow the strict rules that apply to mass-produced drugs. It is generally regulated by states rather than the federal government, which has jurisdiction over manufacturers.
But the company was mass-producing drugs and shipping them all over the country, without the manufacturing standards or inspections imposed on big drug makers. It shipped 16,676 vials of the contaminated steroid, methylprednisolone, to 23 states, and 14,000 people were injected with it.
[Pic: John D Dingell, Democrat of Michigan] Members of the committee said the company had so blatantly crossed the line from compounding to manufacturing that the F.D.A. clearly had the authority and responsibility to oversee it. One said it was nonsensical to suggest that a company could put on a “cloak of invisibility” by declaring itself a compounder.
But Dr. Hamburg said that companies identifying themselves as compounders did not have to register with the F.D.A., show it their records, open themselves to inspection or report adverse effects from their products. She said she wants all of that changed.
“We don’t even know the universe of compounders and what they’re making,” Dr. Hamburg said. Such companies number in the thousands.
Republican committee members took turns scolding Dr. Hamburg, an Obama administration appointee, accusing her of obfuscation, filibustering and lack of leadership. They also complained that her agency had submitted none of the documents it had requested for the investigation.
Democrats, Mr. Dingell notwithstanding, were kinder. But when Dr. Hamburg insisted that the F.D.A.’s authority to regulate compounders was unclear, Representative Henry A. Waxman, Democrat of California, said that if he had been in her position, “I would have assumed the jurisdiction. I would have acted on it.”
Other committee members noted that once the outbreak was recognized, the F.D.A. did raid New England Compounding and seize computers and drug samples. They asked how the agency could do that if it did not have jurisdiction.
Dr. Hamburg did not explain. She said she was deeply troubled by the outbreak. “If there were actions that could have been taken at an earlier time to have prevented it,” she said, “I would wish that that were so.”
Representative Michael C. Burgess, Republican of Texas, said he thought that the F.D.A. already had enough power to have stopped New England Compounding before people died. If, as Dr. Hamburg requested, Congress passes new legislation, he said, “and yet you’re not going to act on that authority, we’re going to be right back in the same soup with this same problem at some point in the future.”
By DENISE GRADY
Published: November 19, 2012
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