A U.S. congressional panel has heard emotional testimony from the widow of a Kentucky judge who was among the first to die in a meningitis outbreak linked to 32 deaths and more than 400 illnesses.
Joyce Lovelace told a House Energy and Commerce subcommittee that better state and federal regulations are needed in order to prevent tragedies, such as the one that resulted in her husband's death in September.
"We have lived a nightmare," Lovelace said. "We will be living this nightmare for ages to come. It is something that we will never really be able to get closure on because it was such a useless thing that happened to my husband."
The House panel is investigating measures to strengthen government authority over so-called compounding pharmacies, facilities licensed to produce small batches of made-to-order prescriptions.
Congressman Fred Upton said he was upset to learn that the now-closed New England Compounding Center, which made the contaminated steroid linked to the meningitis outbreak, had a similar incident a decade ago.
"I was stunned and angered to learn that an inspection of the NECC [New England Compounding Center] by the FDA and the Massachusetts board [Department of Public Health] over 10 years ago identified contamination in the very same drug at issue in the current outbreak," Upton said. "The reason for that inspection: Patients had been hospitalized with meningitis-like symptoms. Ten years later, we are in the midst of an unthinkable worst-case scenario. The body count is growing by the day and hundreds, hundreds have fallen ill. Inexcusable."
Food and Drug Administration Commissioner Margaret Hamburg said her agency had been hampered by limited authority over compounding pharmacies.
"Stronger, clear authority would enable more effective regulation of the drug compounding industry especially when it has been evolving so significantly. As it is, our authority over compounding is limited, unclear and contested," Hamburg said.
New England Compounding Center co-owner Barry Cadden appeared before the panel, but invoked his constitutional right to decline to answer questions.