A US Food and Drug Administration initiative has sped the review and approval process for promising drugs, but researchers from Wake Forest University Medical School note in the Journal of the American Medical Association that some fast-tracked drugs have been associated with safety risks. Thomas Moore and Curt Furberg focus on three drugs — vandetanib, fingolimod, and dabigatran — that have been approved quickly despite some safety concerns and uncertainty regarding dosing. "Although enabling new drugs with a favorable benefit-to-harm balance to become available to patients more rapidly is a laudable goal, the underlying question is what public health risks are taken when drugs are approved for widespread use while important safety questions remain unanswered," Moore and Furberg write.
At Pharmalot, Ed Silver sought comment on the JAMA essay from FDA. A spokesperson told him that the labels for the drugs discussed by Moore and Furberg discuss when it is appropriate for physicians and patients to turn to those drugs. The spokesperson adds that "making regulatory decisions about drugs always involves uncertainty and risk. FDA works directly with the affected patient populations and treating physicians when considering just how much uncertainty and risk are reasonable to accept."