The number of people who have died in a national meningitis outbreak linked to injections of a contaminated drug rose to 11 on Tuesday as lawmakers called for a Congressional inquiry into pharmacies of the kind that made the medicine and new laws to ensure tighter federal oversight of their operations.
In all, a total of 119 people have been affected in the outbreak, the Centers for Disease Control and Prevention said. All of them had been injected with a pain drug shipped around the country by a pharmacy in Massachusetts.
Health officials on Tuesday reported three new deaths, and state and federal health officials scrambled to notify the 13,000 people who may have been given the drug, methylprednisolone acetate, an epidural steroid that is injected into the neck and spine for pain.
The drug that federal health officials suspect was contaminated with fungus was made by the New England Compounding Center, registered as a pharmacy in Framingham, Mass.
Tennessee has had by far the most cases, and state health officials said Tuesday that a fungus called Exserohilum was the primary cause of infection there. Initially, the main suspect was another fungus, Aspergillus. At a news briefing, the state health commissioner, Dr. John Dreyzehner, called Exserohilum "a fungus so rare that most physicians never see it in a lifetime of practicing medicine."
Compounding pharmacists typically prepare medicines for individual patients at a doctor's request. But critics say some of the businesses have become miniature drug companies, without the federal oversight that goes with them.
The New England Compounding Center was founded in 1998, and says it has 49 employees. A Boston public relations man acting as a spokesman for the company, Cosmo Macero, said the company's chief pharmacist, Barry Cadden, is also an owner, as is another company officer, Gregory Conigliaro. He said that both men were "singularly focused on managing the national recall" and that lawyers for the company, which is not now in operation, were not available to comment. Mr. Conigliaro is also associated with a real estate company and a recycling company, according to documents filed with the Massachusetts secretary of state.
"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," said a statement by Representative Henry A. Waxman, Democrat of California, and two other Democrats on the House Energy and Commerce Committee, Diana DeGette of Colorado and Frank Pallone Jr. of New Jersey. The committee has jurisdiction over the Food and Drug Administration.
The Democrats are the minority on the committee and cannot call a hearing. A spokeswoman for the committee's Republican chairman, Fred Upton of Michigan, said he was joining the call for an inquiry, together with three other Republican members.
Representative Edward J. Markey, a Democrat from Massachusetts who represents the district where the New England Compounding Center is based, said he would introduce legislation requiring certain pharmacies that send products across state lines to register with the F.D.A. Currently, states oversee compounding pharmacies.
Federal drug regulators have tried to crack down on the larger compounding pharmacies with limited success. Gary Dykstra, a professor at the University of Georgia College of Pharmacy who was the F.D.A.'s deputy associate commissioner for regulatory affairs in the 1990s, said large-scale compounding first came to the F.D.A.'s attention in the early 1990s.
"They were pushing the limits of pharmacy practice," said Mr. Dykstra, who retired from the F.D.A. in 2007. "We were seeing some very clever entrepreneurs that were trying to get a foothold in what they saw as a need but taking it to extremes."
Inspection proved difficult. They were politically adept, he said, using lobbyists.
"They were making a lot of money so they fought us pretty hard," Mr. Dykstra said. "They argued this was a doctor-patient relationship and the F.D.A. couldn't interfere."
A surge of litigation created uncertainty and raised the specter of costly court cases, dampening the agency's enthusiasm for such cases, he said.
"We would put a lot of work into an investigation but our recommendations would find little support," he said.
The F.D.A. has said it knows of 200 "adverse events," involving 71 compounded products since 1990. Among them were two patients at a Veterans Affairs hospital in Washington who were blinded by a product used in cataract surgery that was contaminated with bacteria. In August 2005, the F.D.A. announced a recall of the contaminated solution.
Denise Grady and Jess Bidgood contributed reporting. Sheelagh McNeill contributed research.
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