Posted: Tuesday, December 24, 2013 6:00 am
I t was too much for federal regulators to ignore and the public to tolerate: 64 people dead after a Massachusetts pharmacy shipped contaminated drugs to 23 states.
The New England Compounding Center in Massachusetts had already been in hot water with both federal and state regulators for a decade leading up to the debacle. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business down, much less allowed it to pump thousands of doses of fungal-contaminated drugs into the patient stream.
To add to federal regulators’ embarrassment, another state had warned the U.S. Food and Drug Administration and Massachusetts regulators about new NECC violations. The warnings were ignored by both and could have prevented at least some of the deaths if heeded.
During U.S. Senate and House committee testimony and public discussions, FDA officials tripped over themselves trying to give explanations and bemoaned that their authority wasn’t clear.
State regulators, including those in Florida, did not fare much better as federal and state studies showed that most individual state pharmacy boards were operating with little more than blinders. Almost none knew what kinds of drugs their pharmacies
were making, how much of it or to what other states they were sending it to.
were making, how much of it or to what other states they were sending it to.
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