BOSTON (AP) — Massachusetts Health and Human Services Secretary JudyAnn Bigby said Wednesday that state overseers and the managers of a compounding pharmacy bear responsibility for a fatal, nationwide outbreak of fungal meningitis.
Bigby told state lawmakers that the Framingham-based New England Compounding Center, which distributed a contaminated steroid that has sickened about 440 people and led to more than 30 deaths, "bears primary responsibility for the harm they have caused."
"NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and violated their pharmacy license, endangering thousands of lives as a result," Bigby said at a joint legislative hearing at the Massachusetts Statehouse.
Meanwhile, NECC co-founder Barry Cadden, called to appear in Washington on Wednesday before the U.S. House Energy and Commerce Committee, declined to testify and instead repeatedly invoked his Fifth Amendment right to not answer questions in order to avoid self-incrimination.
Cadden and the NECC, which has been closed since early last month, are under investigation by both federal and state officials. The NECC said after the first diagnosis of fungal meningitis in Tennessee in September that the company was cooperating with health officials to determine the source. Cadden has not responded to requests for comment.
At the Statehouse, Bigby also said staff for the Massachusetts Board of Registration in Pharmacy, which oversees compounding pharmacies, failed to take appropriate action to toughen oversight of the company at critical junctures during the past decade.
She called "inexplicable" the actions by the board and its staff to weaken a proposed reprimand and probation of the center in 2006, allowing the center to continue operating without disciplinary actions.
"This raises the question of whether they could have prevented all or some of these tragic events," she said. "Poor judgment, missed opportunities and a lack of appropriate action allowed NECC to continue on their troubling course."
Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. In recent decades some compounders, like the NECC, have grown into large businesses that ship thousands of doses of drugs to multiple states.
Bigby said up to 26 additional sterile compounding pharmacies operate in the state.
James DeVita, chairman of the pharmacy board, put responsibility for the deaths back on the company and said the board needs additional resources to expand investigations into the compounding pharmacy industry.
"We are angry. The worst case scenario has happened," DeVita told lawmakers. "It appears that a rogue operator may not have followed the rules."
DeVita also said the state needs to provide more training for inspectors, increase the number of random inspections, and create a separate license for pharmacies that engage in compounding that's distinct from the licenses given to neighborhood drug stores.
DeVita said he thought the resolution with the center in 2006 was a good outcome for the public even though it resulted in a lesser sanction because the agreement included steps the company was supposed to take to ensure quality.
Rep. Harold Naughton, House chairman of the Committee on Public Safety and Homeland Security, said the series of events that led to the deaths and illness is troubling. He said Cadden exploited what Naughton called a "wasteland of the law" between federal and state regulations.
"They intentionally took advantage of an area of the law where they knew they were not being looked at and basically became a mass-producing pharmacy and gave up on their quality control," said Naughton, D-Clinton. "I lay that squarely at the feet of Barry Cadden and his company."