GMP CONSENT DECREES
This article was originally published in The Gold Sheet
Executive Summary
...are prompting pharmaceutical executives industry-wide to reevaluate their commitment to quality control as financial costs associated with the agreements escalate. Schering-Plough's $500 mil. "disgorgement of profit" is the largest such penalty levied in FDA's effort to magnify the deterrent power of the decrees. The agreements stipulate remedies, such as the use of outside consultants, meant to address the deficiencies in corporate culture that allow recidivism to become a problem. Industry experts advise firms with recurrent compliance problems to proactively implement consent decree-like corrective actions to forestall injunctions. Companies like Abbott already operating under a decree are finding that costs are mounting as they struggle to meet the tough strictures involved. FDA and industry agree that better clarification of GMP expectations and the implementation of advanced control technologies could help reduce the cost of enforcement and improve quality.