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Wed November 14, 2012
Beacon Hill Hears Testimony on Compound Pharmacy Violations
The New England Compounding Center was the subject of hearings in Boston and Washington today, as it faces blame for a meningitis outbreak linked to steroid injections it produced. At least 32 people have died and 440 are sick.
Lawmakers on the Massachusetts Joint Committee on Public Health grilled six regulators to find out why the New England Compounding Center’s steroids were contaminated with fungal meningitis.
“We call this hearing as House members and chairmen of legislative committees in response to two critical breakdowns in government accountability in pharmacy oversight and also the state drug lab,” said Jeffrey Sánchez, chair of the committee. He and other legislators began the day by questioning Massachusetts Health and Human Services Secretary JudyAnn Bigby for over an hour. Bigby said she and other state officials and the compounding pharmacy managers are responsible for the contaminations, lack of sterility tests and unsanitary pharmacy conditions. But she called the state’s inability to prevent the outbreak “inexplicable.”
“These events have uncovered unacceptable breaches on the part of individuals, gaps in regulatory processes and above all a need for immediate and lasting solutions. I am committed to answering the questions, ‘How could this have happened?’ and ‘How do we prevent it from ever happening again?’” Bigby asked.
But there was tension because those questions weren’t answered in detail. A compounding pharmacy mixes ingredients to produce medication for a specific patient based on a valid prescription, and is not supposed to produce those medications in bulk. When asked by Sanchez how many compounding pharmacies exist in Massachusetts, Bigby had this response: "Um, we are aware that there are at least 25 to 26, there is not a different designation for compounding pharmacies because all thousand-plus pharmacies do some kind of compounding."
Complaints have been launched against the compounding pharmacy since 1999, just a year after it opened. Essentially, the conclusion among regulators was to pledge accountability and proper oversight in the future.