FDA needs pharmacies' buy-in Agency has more authority, but how it will proceed is not yet clear

By FRED HIERS Halifax Media Group

Published: Friday, January 3, 2014 at 1:00 a.m.

Last Modified: Thursday, January 2, 2014 at 10:40 p.m.

It 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. The Massachusetts violations had left many angry national lawmakers asking why federal regulators had not closed the business, 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.

 

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