Yesterday, Governor of Massachusetts Deval Patrick and the state Department of Public Health released more details of their investigation into the compounding pharmacy at the heart of a meningitis outbreak that has sickened more than 300 people. WAMC’s Berkshire Bureau Chief Lucas Willard reports…
Since injectable steroids manufactured and distributed by New England Compound Center in Framingham Massachusetts were discovered to be the cause of an outbreak of fungal meningitis, the Commonwealth has launched an investigation with Federal officials on the incident.
Massachusetts Governor Deval Patrick spoke to the press yesterday and gave an update of the situation.
The governor was joined by Dr. Madeleine Biondolillo, Director for Health Care Safety and Quality at the Massachusetts Department of Public Health. Dr. Biondolillo said that the investigation by state health officials found that New England Compounding Center was in violation of several health and safety standards, including ones pertaining to basic sterilization methods.
The outbreak of meningitis, a disease characterized by a swelling the brain and spinal tissues associated with microbial infection, has killed 23 people in a total of 317 cases in 17 states, according to the Centers for Disease Control and Prevention.
Dr. Biondolillo says some recalled steroid shots returned to NECC were found to have plainly visible signs of contamination.
New England Compounding Center was found to be in violation of its state license which only allows for the filling of specific prescriptions. Governor Patrick said the company acted instead like a wholesale drug manufacturer. The Governor also gave details on how all 25 pharmaceutical compounding centers in Massachusetts will be placed under stricter regulations, including more frequent inspections from the state Board of Pharmacy. Compounding pharmacies will also be required to report all interactions with federal regulators to state authorities, and a commission will be formed to determine a course of action including future changes in state law.
The U.S. Food and Drug Administration is also involved in investigations, and a Federal criminal investigation is also underway.
The FDA is facing criticisms on its lack of oversight that some are saying lead to the large scale outbreak. Group Public Citizen sent a letter today to the US Department of Health and Human Services calling for an independent investigation to take a look at how the FDA was irresponsible for failing to prevent the outbreak.