The Wall Street Journal's conservative editorial board ripped President Donald Trump's Food and Drug Administration leader in a new editorial on Tuesday.
FDA Commissioner Marty Makary said Monday that his office is pursuing a new way to provide more flexible reviews of drugs used to treat rare diseases. However, the Journal's editors argued that the idea seems to fly in the face of the FDA's mission.
"A good idea. But is the Commissioner paying attention to what his biologics chief Vinay Prasad is doing that conflicts with this goal?" the editors wrote.
"That’s the operating contradiction at FDA, after the agency this month rejected two rare disease drugs seeking accelerated approval," they added. "Congress in 2012 enacted the accelerated approval pathway to fast-track medicines that treat life-threatening diseases. Dr. Prasad is quietly undermining the program."
The editors also noted that the FDA recently turned down a drug for reasons that seem to contradict Makary's idea for accelerated reviews.
"All of which makes us and many others wonder who’s really in charge at the FDA," they wrote. "Dr. Makary likes to boast that the FDA is becoming more flexible and expediting breakthrough treatments. Dr. Prasad is doing the opposite."
