The potential risks of expedited approval of drugs for acute bacterial infections.

Abstract

Each year, about 23,000 people in the United States die from antibiotic-resistant infections. For many of these infections, safe and effective treatments are lacking. To address this problem, the Food and Drug Administration (FDA) has updated several expedited approval programs for new antibacterial therapies, some of which alter the evidentiary standard for drug approval.1,2 For instance, a drug may be eligible for “accelerated approval” if it “has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.”2 Since 1992, the accelerated approval program has been available for drugs likely to offer a therapeutic benefit over available treatments for serious or life-threatening diseases. Now, the program’s scope has been expanded to include drugs with marginal ancillary benefits such as a novel mechanism of action without improvements in safety or efficacy. These well-intentioned new standards for accelerated drug approval have increased the risk that the agency will approve antimicrobials that are less effective or more harmful than available treatments.