Protracted correspondence between drugmakers and the FDA in sorting out the fixes to GMP violations is likely becoming a high-risk undertaking. The FDA has indicated that from here on in, it will have limited tolerance for manufacturers that make promises they don't keep. Instead of sending stern replies as follow-up to incomplete and inadequate drugmaker responses to warning letters, the regulator is now planning to prosecute.
Top managers at drug companies have in the past been convicted or pleaded guilty to felony acts, according to the Justice Department. Six such cases have involved misbranding and promoting off-label uses, says BusinessWeek. But felony convictions are rare.
Misdemeanors are a different thing, though. And the FDA, in a nod toward a Congress that wants to get tough with drugmakers, has signaled that it intends to pursue such convictions. It plans to do so via The Food and Drug Act, which allows misdemeanor convictions without proof of intent to do wrong--the element that makes felony convictions so hard to come by.
So a C-level stint behind bars may become the consequence of poor follow-up to promised GMP fixes and less-than-complete disclosure of manufacturing foul-ups. Recent incidents like the long time lags between company discovery of problems and the reporting of them to the FDA (the recent Tylenol recall), may now have a much higher price tag. So too with unfulfilled promises of corrective action, like those made recently by Sunshine Pharmaceuticals, which prompt warnings that usually ooze exasperation despite inspectors' best attempts at professionalism.
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