At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now.

Iowa Senator Tom Harkin says he believes the Senate is close to getting legislation that would give the FDA specific control over large pharmacies like the one behind the outbreak of fungal meningitis that’s killed 55 people so far. The hope is to prevent any more of these outbreaks.

“We must have changes or this is going to happen again,” Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a hearing of the Senates Health, Education, Labor and Pensions Committee Thursday. Harkin, a Democrat, chairs the committee.

“This tragedy was only the worst in a series of incidents involving compounded products,” Woodcock added. “In retrospect, FDA should have been more aggressive… We are being more aggressive now.”

More than 740 people have been sickened in the outbreak of disease linked to contaminated products distributed by the New England Compounding Center in Massachusetts last year. At latest count, the Centers for Disease Control and Prevention says, 55 have died from a rare form of meningitis caused by mold-contaminated steroid injections.

The Pew Charitable Trusts ran down some recent incidents and came up with 19 other compounding pharmacy errors that led to 22 deaths since 2001. And at least 38 patients were blinded or suffered vision loss because of contaminated eye injections.

The cases include three people killed and 11 sickened in California in 2001 from contaminated injections of a steroid called betamethasone. Five had bacterial meningitis. They also include overdoses from saline solutions that had too much sodium and bloodstream infections from various contaminated infusion products.

"I think it's unconscionable that we have failed to regulate this industry for so long and I am committed to moving forward," Sen. Elizabeth Warren, a Massachusetts Democrat, said at the hearing. But previous efforts to give the FDA more power have fallen apart, most recently in 2007. Tennessee Sen. Lamar Alexander, a Republican, said lobbying by the compounding pharmacy pressured lawmakers into dropping the legislation.

Inspections of NECC showed many of its products were contaminated with fungus and bacteria. The operation has been closed down and the FDA and several states have stepped up inspections of large-scale pharmacies.

The FDA says the problem has arisen because so many compounding pharmacies have become major manufacturers of products from saline solution to chemotherapy drugs. They were originally licensed to whip up treatments on a prescription-by-prescription basis, but many now make products far in advance of their being prescribed, and ship them all over the country.

What has not been clear is who regulates them, and the FDA says many of these operations use the lack of clear regulation as an excuse to fend off efforts to inspect them and see their records. States are supposed to regulate traditional pharmacies, including compounding pharmacies. FDA regulates large drug manufacturers.

The Senate legislation, proposed by the FDA, would create a third category – large-scale compounders – that it would regulate.

State pharmacy boards said they’d support the new legislation. “We agree with the FDA that the situation can and will happen again,” Carmen Catizone, executive director of the National Association of Boards of Pharmacy, told the hearing. He did question one part of the proposed law – allowing FDA to get into the records of pharmacies regulated by states, saying it could cause confusion.

The consumer group Public Citizen opposes the new legislation, saying the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act. Woodcock says this isn’t true and says pharmacies regularly defy the agency when it tries to inspect facilities and their records.

“We need to get into pharmacies to make sure they are not posing as traditional pharmacies,” she told the hearing. “Sometimes, if there is an outbreak, we get reports and they say, ‘no you can’t come into our pharmacy’. “ Without seeing records, Woodcock says, FDA can’t tell where a contaminated drug may have been shipped.

This, in turn, makes it hard to track outbreaks. A person with a complication caused by a contaminated drug may not even know which product caused it.

Pew supports prioritized oversight of sterile products, notes there are a number of areas it would miss. These include non-sterile compounded drugs, such as compounded “bioidentical” hormone replacement pills. ”Compounded oral dosage forms have the potential to cause harm by both impurities and sub- or super-potency,” Pew’s Allan Coukell told the hearing.

It would also leave large pharmacies that don’t ship their products out of state free to operate under the FDA’s radar, Coukell noted.

Related:

• FDA inspection prompts recall by Florida pharmacy
• Months after outbreak, patients still being newly diagnosed
• Agencies do battle with pharmacies after outbreak
• We didn't have power to stop fungal meningitis, FDA says

Susan Walsh / AP

Barry Cadden, president and co-owner of the New England Compounding Center, shown being sworn at a House Energy and Commerce oversight subcommittee hearing on Nov. 14, took the fifth and refused to testify.

The owner of a pharmacy at the center of an outbreak of fungal meningitis caused by contaminated pain drugs that have killed 32 people and made 461 people sick refused to testify at a packed hearing on Wednesday, and managed to avoid facing the family of his first victim.

Barry Cadden, president, co-owner and director of pharmacy for the New England Compounding Center, remained in a separate room with his lawyers while the wife of his first victim testified, then managed to avoid her in the hallway as she left the committee room. He took the fifth, invoking his constitutional rights not to testify -- even when asked whether he was the owner of the pharmacy.

Robbed of a chance to confront Cadden, members of the House Energy and Commerce oversight subcommittee instead spent hours berating the Food and Drug Administration. Despite their outrage over the growing toll from the outbreak, Republican members of the committee made it clear they are not ready to change any legislation just yet.

“We will be living with this nightmare for ages to come,” Joyce Lovelace of Albany, Ky., whose husband, Eddie, was the first person to die in the outbreak of fungal meningitis traced to the pharmacy, told the hearing.

“We now know that New England Compounding Pharmacy Inc. killed Eddie. I have lost my soul-mate and life’s partner with whom I worked side by side, day after day for more than 50 years,” said Lovelace, her voice cracking as she testified.

“It was not an easy death that we witnessed,” she added.

Lovelace said her husband, a 78-year-old judge, had been healthy and active before the spinal injections that killed him.

“I am asking this committee to find out how and why this happened and to plug the loopholes that allow these industries to escape meaningful inspection,” Lovelace said.

“I would ask that you inquire how such a product became so widely distributed. Why did so many medical providers purchase this product from unregulated or poorly regulated sources? Don’t just investigate. Instead, legislate and regulate.”

Cadden and his lawyers waited until Lovelace, who uses a wheelchair, was wheeled out of sight before they entered the committee room. He immediately made it clear he wouldn't testify. “Will you invoke your Fifth Amendment rights to all questions today?” Rep. Cliff Stearns, the Florida Republican who chairs the panel, asked Cadden. “Yes,” Cadden replied. Stearns then excused him.

Two top regulators then faced the frustrated panel for more than two hours.

If Congress doesn't strengthen legislation, another similar tragedy is inevitable, said FDA Commissioner Dr. Margaret Hamburg. "If we fail to act, this type of incident will happen again. It is a matter of when, not if," she said.

But committee members said the FDA and Massachusetts state regulators both knew as far back as 2002 that there were problems at the pharmacy, which distributed more than 17,000 doses from contaminated lots of steroids. Yet they failed to take forceful enough action, members said.

"This is a complete and utter failure on the part of your agency," Stearns told Hamburg.

“This one of the worst public health disasters ever caused by a contaminated drug in this country,” added Stearns, a Republican who chairs the oversight subcommittee.

“After a tragedy like this the first question we all ask is ‘Could this have been prevented?’” Stearns added. “After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer here appears to be, 'Yes.'”

An Energy and Commerce Committee report noted that the FDA and the Massachusetts state board of pharmacy both repeatedly visited NECC and found problems. But the strongest action that anyone took was a warning letter issued by FDA in 2006.

“You can take a regulator to a problem but you can’t make him regulate,” said Rep. Joe Barton of Texas. “It’s an absolute tragedy without any question that 32 people have died.”

Hamburg said the agency doesn’t have the authority to regulate compounding pharmacies in the way it does drug manufacturers. Legislation passed in 1997 was never enforced after the Supreme Court found part of it unconstitutional because it banned compounding pharmacies from advertising.

Compounding pharmacies are supposed to mix drugs to order based on specific prescriptions, and FDA and the Massachusetts regulators both knew that NECC was mass-producing and distributing drugs without individual prescriptions. Hamburg confirmed FDA teams found unsanitary conditions at NECC as far back as 2002.

“Throughout this time NECC has repeatedly disputed FDA’s jurisdiction over its facility,” she said. “The agency has struggled with how to chart an effective course to protect public health."

She said there are thousands more compounding pharmacies like NECC. "The industry has evolved well beyond the neighborhood pharmacy.”

Dr. Lauren Smith, who is interim commissioner of the Massachusetts Department of Public Health, said pharmacy board members who failed to act against NECC had been fired. James Coffey, director of the state’s pharmacy board, was dismissed earlier this month.

Smith also said the state had issued emergency regulations to deal with NECC and its sister pharmacy, Ameridose, which was licensed to mass-distribute medical supplies. Sterility problems were also found there, although no infections have been linked to that firm. 

"As we work to raise standards in Massachusetts, we urge Congress to act to strengthen federal oversight. It is clear that the patchwork of disparate state regulations is not enough to keep the public safe,” Smith said.

California Democrat Henry Waxman urged his fellow panel members to get legislation written quickly, even though Congress is expected to do little between now and the end of the year, with the notable exception of budget negotiations. "Let's not lose sight of the wrongdoing as we go around blaming the regulators," he said. "I think we want to work during this lame duck session to pass bipartisan legislation," he added.

"We need to correct the law and we need to do it before we leave at the end of this year."

But Republicans said they were not convinced new legislation was really needed. Stearns said it was "incomprehensible" that the FDA didn't act even though it was aware that NECC was working on a scale far beyond its license in 2002.

"If they didn't exercise the authority they already had, new authority isn't going to solve the problem," said Michael Burgess, a Republican from Texas.

Waxman accused his colleagues of playing politics. "I have a feeling, Dr. Hamburg, that you are being picked on because you are a member of the Obama administration," he said.

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