FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers Say

The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies.

In an analysis of 76 drugs granted expedited review by the FDA between 1999 and 2012 — through the agency’s accelerated approval, fast track and priority review programs — researchers from Tufts Medical Center found that drugs in at least one program saw greater gains in quality-adjusted life-years than those that went through traditional agency review and approval.

In addition, drugs in multiple expedited review programs had nearly twice the gains of those granted access to a single program.