FDA Tried to Close Compounding Pharmacy 10 Years ago
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Federal health inspectors wanted to shut down the pharmacy linked to the deadly meningitis outbreak back in 2003, and reported concerns as early as 2002, according to a new report released by the House Energy and Commerce Committee. The 25-page report was released Monday, ahead of Wednesday’s meeting, where FDA Commissioner Margaret Hamburg and Massachusetts Department of Public Health interim commissioner Lauren Smith are scheduled to testify. The report has information and quotes from the FDA, state inspection reports, and internal memos. The AP says:
The report shows that after numerous complaints over years, Food and Drug Administration officials in 2002 suggested that the compounding pharmacy be “prohibited from manufacturing” until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.
In 2003, FDA officals met with state and federal officals and voiced their concerns. They said, “…the potential for serious public consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.”
The FDA let Massachusetts officials take the lead in regulating the New England Compounding Center since it is typically done at the state level. In the released report the investigators said that, “The state would be in a better position to gain compliance or take regulatory action against NECC as necessary.”
The AP story says:
The NECC has been closed since early last month, and Massachusetts officials have taken steps to permanently revoke its license. The pharmacy has recalled all the products it makes, including 17,700 single-dose vials of a steroid that tested positive for the fungus tied to the outbreak.