By Lena H. Sun and Kimberly Kindy,
Feb 08, 2013 11:46 PM EST
The Washington Post Friday, February 8, 5:46 PM
The Food and Drug Administration has reached a “critical point” in its struggle to oversee specialty pharmacies that have been associated with mounting illnesses and deaths, the head of the agency said Friday.
FDA Commissioner Margaret Hamburg’s comments came in response to a Washington Post investigation that found that shoddy practices and unsanitary conditions at three large-scale specialty pharmacies have been tied to deaths and illnesses over the past decade. Those safety lapses occurred long before national attention focused on New England Compounding Center (NECC), the Massachusetts company whose tainted steroid shots were at the center of last fall’s deadly meningitis outbreak.
Hamburg said the agency needs new, stronger and clearer legislation to oversee “firms engaged in large-scale distribution” of custom-mixed, or compounded, drugs, some of which were highlighted in the Post article. The current patchwork of federal and state laws is too weak to protect patients in all 50 states from high-risk compounding operations, she said in a statement.
“We’ve reached a critical point on this issue,” Hamburg said.
Rep. Edward J. Markey (D-Mass.), who released a report last fall showing uneven oversight by state authorities, said Friday that the FDA needs greater authority. He plans to reintroduce legislation that would allow the agency to regulate compounders that act more like drug manufacturers.
“These compounding pharmacies have been operating under the radar for too long,” he said in a statement.
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