FDA promises elevated new drug approvals, but warns of potential pitfalls

The FDA has approved 14 new drugs so far this year, lagging behind the 20 approvals it had charted by this time last year. Is it a sign that the FDA is becoming more cautious in the wake of Scott Gottlieb’s departure? After all, it was under his tutelage that the agency churned out a record 56 green lights in 2018. Don’t worry, biopharma industry: The FDA's still committed to accelerated drug development and approvals. That was the message from the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., who appeared Tuesday at the SVB Leerink Therapeutics Day in Boston. Woodcock said the “current elevated numbers” of new approvals would stay steady or even increase, according to a report SVB Leerink sent to clients today. “In fact, Dr. Woodcock believes that the drug industry is just beginning to see the fruits of the human genome sequencing and expects more and more approvals in future years,” the report said. During the SVB Leerink event, Woodcock said the FDA has been adapting to pharma's shift toward developing therapies for serious, difficult-to-treat diseases. “The FDA has heard from patients with these diseases that they have a willingness to assume a higher risk of uncertain efficacy and toxicity from investigational drugs and the agency has incorporated this into their review and approval decisions," the report said.