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Congress seeks probe of pharmacy in fungal meningitis outbreak

Dominick Reuter / Reuters

A Framingham police officer (in doorway) keeps watch as federal agents search the New England Compounding Center company in Framingham, Massachusetts October 16, 2012.

By The Associated Press

Two members of Congress have asked the U.S. Department of Justice to investigate whether a specialty pharmacy linked to a nationwide meningitis outbreak violated any federal laws or regulations.

The number of illnesses associated with contaminated steroid shots distributed by New England Compounding Center climbed to 233 in 15 states, the Centers for Disease Control and Prevention reported Tuesday. Fifteen people have died.

Criminal investigators from the Food and Drug Administration were at the Framingham company on Tuesday. FDA spokesman Steven Immergut said the investigators were there as part of a broad investigation by several state and federal agencies into the outbreak.

Company attorney Paul Cirel said it was "difficult to understand the purpose" of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.

"We've been clear that warrants weren't needed; asking would have produced the same result," he said. "Nevertheless, we continue to offer our cooperation."

Boston U.S. Attorney Carmen Ortiz confirmed that her office is part of the investigation.

Rep. Edward Markey, D-Massachusetts, wrote in a letter to the Department of Justice that the list of products recalled by the company appears to include controlled substances that fall under the jurisdiction of the Drug Enforcement Agency.

The DEA requires pharmacies that sell or compound controlled substances to be registered with the agency, which NECC was not, Markey wrote. He added that the rules only allow pharmacies to sell controlled substances directly to patients with specific prescriptions unless the pharmacies register with the DEA as manufacturers or suppliers.

"This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances," said Markey, a member of the Energy and Commerce Committee in whose district the company is located.

Gov. Deval Patrick said last week that NECC might have misled regulators and done work beyond the scope of its state license. Federal and state investigators have said they have found fungus in more than 50 vials from the company, but they have not said whether they have pinpointed the source of the contamination.

In a recent letter to U.S. Attorney General Eric Holder, Sen. Richard Blumenthal, a Connecticut Democrat, also called for a criminal investigation of the company, its officers and employees, pointing to reports that NECC may have "flagrantly and blatantly violated" state and federal laws.

The Department of Justice had no immediate comment on the letters.

NECC, in a statement, did not directly respond to the legislators but said it was cooperating with ongoing probes by other agencies.

The CDC said Tuesday that 231 of the reported illnesses were cases of fungal meningitis linked to shots for back pain and two others were nonfatal joint infections.

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How did the drugs get contaminated?