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Wed November 14, 2012
Shots - Health News

Lawmakers Clash With FDA Over Meningitis Outbreak

Originally published on Wed November 14, 2012 6:17 pm

Members of a House subcommittee clashed repeatedly Wednesday with U.S. Food and Drug Commissioner Margaret Hamburg over the outbreak of meningitis caused by contaminated steroid injections.

During a tense four-hour hearing called to investigate the outbreak, members of the House Subcommittee on Oversight and Investigations repeatedly pressed Hamburg on why the agency had allowed the New England Compounding Center to keep operating years after problems had emerged. The NECC produced the tainted injections that killed 32 people and sickened 460 others.

"Do you think the FDA had the authority to shut down NECC, yes or no?" Committee Chairman Rep. Cliff Stearns (R-Fla.) asked Hamburg. Hamburg, Stearns and other members of the committee repeatedly interrupted each other during the questioning.

One of the first to die was Eddie Lovelace, who had a fatal stroke after getting three injections. His wife, Joyce, started the hearing with a plea.

"My family is bitter. We are angry. We're heartbroken. We're devastated. And I just come here begging you to do something about the matter," she said.

To try to do that, the committee subpoenaed Barry Cadden, co-owner of NECC. Stearns tried repeatedly to question Cadden, but Cadden repeatedly refused, citing his right not to incriminate himself.

But the sharpest exchanges came when Hamburg sat down in the witness chair. Stearns demanded to know why the FDA let the pharmacy continue shipping drugs for years after sending a warning letter about problems in 2006.

"The fact is the warning letter did not involve sterility failures and it was not in relation to the kinds of problems that we're addressing now," Hamburg said, prompting Stearn to reply: "So you're saying your warning letter was an empty threat?"

Hamburg said the agency did what it could, arguing the FDA needs Congress to give the agency clear legal authority over so-called compounding pharmacies. These are pharmacies that are supposed to custom-mix small batches of drugs, but in some cases have become essentially small drug companies. She brought a map of the U.S., which she said showed that conflicting court rulings had left the FDA's authority unclear.

"We have ambiguous, fragmented, unclear and contested authorities in this particular realm of pharmacy and drug-manufacturing practice," Hamburg said.

But several Republican members of the committee expressed skepticism that the FDA needed more authority than it already has.

"I think we ought to work on using the authority that we have as opposed to trying to get additional authority at the federal level," said Rep. Joe Barton (R-Texas).

Even some Democrats expressed frustration over some of Hamburg's answers.

"We have to figure out how to give you the jurisdiction to do what you need to do, OK?" said Rep. Diana DeGette (D-Colo). "And these inconclusive answers are not helping us."

After nearly three hours, it was clear few committee members were satisfied with what they had heard from Hamburg. A Senate committee is holding its own hearing into the meningitis outbreak Thursday.

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Transcript

MELISSA BLOCK, HOST:

Congress opened two days of hearings today into the recent meningitis outbreak caused by contaminated steroid injections. As NPR's Rob Stein reports, in today's 10th hearing, members of Congress clashed repeatedly with the head of the Food and Drug Administration.

ROB STEIN, BYLINE: More than 460 people have gotten sick from the contaminated shots, including 32 who have died. One of the first to die was Eddie Lovelace, who had a fatal stroke after getting three injections. His wife, Joyce, started today's hearing with a plea.

JOYCE LOVELACE: My family is bitter. We are angry. We're heartbroken. We're devastated. And I've just come here begging you to do something about the matter.

STEIN: To try to do that, the committee subpoenaed Barry Cadden, co-owner of the Massachusetts pharmacy that produced the tainted steroid. Committee Chairman Cliff Stearns tried repeatedly to question Cadden.

REPRESENTATIVE CLIFF STEARNS: For the sake of protecting the public health and preventing something like this from ever happening again and to provide some explanation to grieving families, can you please tell us, what was the breakdown that led to the contamination and the meningitis outbreak?

BARRY CADDEN: Mr. Chairman, on the advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges...

STEIN: Stearns quickly gave up. But the sharpest exchanges came when FDA Commissioner Margaret Hamburg sat down in the witness chair. Stearns, a Republican from Florida, immediately began challenging Hamburg about why the agency had not shut down the New England Compounding Center, known as NECC.

STEARNS: Do you think the FDA had the authority to shut down NECC? Yes or no?

DR. MARGARET HAMBURG: I think that is a very, very complex question in that the legal framework...

STEARNS: So you can't answer that question at all?

HAMBURG: ...for FDA activities is very, very unclear. It has limited...

STEARNS: OK. OK. Let me ask another question. If you're not going to answer the question, let me answer it.

STEIN: For more than two hours, Stearns and other committee members clashed with Hamburg. Stearns demanded to know why the FDA let the pharmacy continue shipping drugs for years even after sending the pharmacy a letter about problems.

HAMBURG: The fact is the warning letter...

STEARNS: The question is did you have the authority...

HAMBURG: ...did not involve sterility failures, and it was not in relation to the kinds of problems that we're addressing now.

STEARNS: So you're saying your letter was an empty threat?

STEIN: Hamburg said the agency did what it could. She says the FDA needs Congress to give the agency clear legal authority over so-called compounding pharmacies. These are pharmacies that are supposed to custom-mix small batches of drugs, but in some cases have become essentially small drug companies. She brought a big map of the United States, which she said showed conflicting court rulings had left the FDA's authority unclear.

HAMBURG: I believe that we need legislation...

STEARNS: So you cannot stop unless you have more legislation.

HAMBURG: ...to sanction and clarify authority. But in the interim, we are working very hard.

STEIN: But several Republican members of the committee expressed skepticism that the FDA needed more authority than it already has. Here's Joe Barton of Texas.

REPRESENTATIVE JOE LINUS BARTON: You know, I think we ought to work on using the authority that we have as opposed to trying to get additional authority at the federal level.

STEIN: And even some of the Democrats expressed frustration over some of Hamburg's answers. Here's Diana DeGette of Colorado.

REPRESENTATIVE DIANA LOUISE DEGETTE: So we have to figure out how to give you the jurisdiction to do what you need to do, OK?

HAMBURG: Agreed.

DEGETTE: And these inconclusive answers are not helping us.

STEIN: After nearly three hours, it was clear few committee members were satisfied with what they had heard. A Senate committee is holding its own hearing into the meningitis outbreak on Thursday. Rob Stein, NPR News, Washington.

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