MASSDEVICE ON CALL — Abbott (NYSE:ABT) settled a consent decree with the FDA a full 12 years after the watchdog agency flagged it for manufacturing problems in its diagnostics unit.
The 1999 decree settled "a remarkable six-year run of manufacturing deficiencies and subsequent failures to fix various problems," according to the Pharmalot blog.
The decree was closed out last month, an FDA spokeswoman told the blog.
"Many consent decrees that FDA enters with firms allow the firms, under defined circumstances, to seek court termination of the decrees following extended periods of compliance. That is the case with this one," according to the spokeswoman.
Abbott, which paid a $100 million fine when the decree was issued in 1999, just agreed to dole out another $1.6 billion to settle charges that it illegally marketed its Depakote drug to treat Alzheimer’s disease.
Putting both cases behind it will likely help smooth the way for a carveout of Abbott’s research pharmaceuticals business, to be named AbbVie, later this year.
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