2. Ex-FDA head has (legitimate?) concerns

Fresh off the clock, ex-FDA commish Robert Califf recently vented a few concerns he has with speeding up drug approvals. #1: Faster approval does nothing to address popular concern for the cost of drugs. Pharma will still say they must recoup hefty development costs and people will still not trust that explanation. #2: Are speed and safety at odds? As Califf puts it, “Declaring a drug safe after very little information is treacherous.” All drugs have risk and this risk is only uncovered through evidence. Check out 22 case studies where the bottom fell out between Phase II and III. And #3: Drugs can’t be approved faster if the FDA needs more FDA-ites – employees. We’re not sure what they call themselves.