Federal and Massachusetts officials said Thursday that they lacked clear authority to take action earlier against a now-shuttered specialty pharmacy that set off safety alarms at least six years ago and is now at the center of a burgeoning meningitis outbreak.
In a teleconference with reporters, the officials described a murky, archaic regulatory apparatus that hampered their ability to keep pace with the rapid changes in compounding pharmacies. That industry, which traditionally has consisted of mom-and-pop operations making customized medicines for individual patients, has expanded to include high-volume pharmacies that rival the production of drug manufacturers.
Deborah M. Autor, deputy Food and Drug Administration commissioner for global operations and policy, said it was “really unfortunate that it sometimes takes a tragedy” to bring about change and called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.” She also said the company could face criminal prosecution.
The officials were responding to questions about why state and federal authorities didn’t move more aggressively against New England Compounding Center in Framingham, Mass., after the FDA found problems during an inspection in 2006. Massachusetts Attorney General Martha Coakley announced an investigation of the NECC after state health officials said the company appeared to violate state licensing requirements.
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