While narrower bioequivalence margins might be necessary for certain categories of generic drugs, FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee has determined that the specifications should not be tightened across the board for all generic drug approvals.
On April 13, the panel voted that current bioequivalence standards are not sufficient for generic versions of "critical dose" drugs, drugs where there is a narrow therapeutic index and deviations can result in therapeutic failure or adverse drug reaction. But on April 14, the committee pulled back from FDA's proposal to revise the bioequivalence margins for all generics, rejecting that idea in a 12-2 vote.
FDA officials presenting at the meeting signaled strong agency support for the move.
