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FDA seeks more authority amid meningitis outbreak

Associated Press Modified: November 14, 2012 at 8:32 pm •  Published: November 14, 2012

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

In prepared testimony, Hamburg suggested putting in place a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, but larger pharmacies would be subject to FDA oversight. Hamburg said regulators would have to consider multiple factors, including how much interstate business a pharmacy does, to identify non-traditional compounders.

These non-traditional pharmacies would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. Large compounding pharmacies would also have to meet the more stringent manufacturing standards required of pharmaceutical companies.

Earlier in the hearing, the owner and director of the NECC declined to testify, invoking his Fifth Amendment right to not answer questions in order to avoid self-incrimination.

Despite his silence, lawmakers repeatedly pressed Barry Cadden to account for the problems that led to the outbreak.

"Mr. Cadden, what explanation can you give the families who have lost their loved ones, and those who are gravely ill, for the actions of your company?" asked Stearns, who heads the subcommittee on oversight and investigations.

Flanked by two lawyers, Cadden told lawmakers, "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."

Federal officials have opened a criminal investigation of Cadden and the NECC.

The Framingham, Mass.-based pharmacy has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license.

Inspections last month found a host of potential contaminants at NECC's facility, including standing water, mold and water droplets. Compounded drugs are supposed to be prepared in temperature-controlled clean rooms to maintain sterility.

Cadden appeared immediately after the widow of a longtime Kentucky judge who died after receiving multiple doses of NECC's steroid injection.

Speaking without notes, Joyce Lovelace told lawmakers of more than 50 years of marriage to 78-year-old Eddie Lovelace, who was a circuit judge before his death on Sept. 17 at Vanderbilt University Medical Center.

"My family is bitter, we are angry, we are heartbroken and devastated. I come here begging you to do something about the matter," Lovelace said.

Health officials say as many as 14,000 people received the methylprednisolone acetate steroid shots, mostly for back pain. The Centers for Disease Control later showed that at least two lots of the injections distributed to 23 states were contaminated with fungus. The fungal meningitis outbreak was first discovered in September, though CDC officials say the earliest deaths connected to the outbreak date back to July.

Fungal meningitis causes inflammation of the lining of the brain and spinal cord.