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Senate moves closer to law to prevent more pharmacy outbreaks

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.