Will US FDA Offer Regulatory Flexibility For ANDAs Downgraded Because Of CRO Investigation?
Complex generic may have some wiggle room, but the only choice for many sponsors may be to redo the affected studies or withdraw the products that have lost bioequivalence status after FDA questioned the integrity of the data from two contract researchers.
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After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.
The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.