P
resident Donald Trump wants to remake the Food and Drug Administration. And he happens to have a “fantastic person” in mind to do it, he said Tuesday — someone who will turn the agency into an industry-friendly shop that cranks out new cures on the double.
But does anyone really want a deregulated FDA? STAT canvassed biopharma insiders, physicians, Wall Street analysts, and FDA veterans. Their verdict: Trump’s plan sounds like a solution in search of a problem.
Trump is weighing several candidates for FDA commissioner who would seek to radically change how the agency vets new drugs. One candidate has proposed scaling back the requirements for approval and letting doctors and patients sort out what’s worth trying. Another once claimed a “Yelp for drugs,” posting consumer reviews of medications, would better serve patients than the existing FDA. A third favors approving treatments once they’ve passed an initial safety test, regardless of whether they work.
Such sweeping changes to the FDA’s standards could rattle the biopharma industry’s very foundation. Investors rely on the agency as a watchdog to keep companies honest. Doctors trust it to safeguard their patients from pharmaceutical snake oil. And, much as they grumble about regulation, even drug manufacturers count on the FDA to maintain a high standard, protecting their profits by blocking rivals whose products aren’t up to par.
Strip all that away and the business of making, prescribing, and profiting from new drugs could be plunged into uncertainty.
“It would be chaotic,” said Dr. David Knopman, a Mayo Clinic neurologist. Speeding up the development of powerful new treatments is a laudable goal, he said, but exposing patients to costly, ineffective, and potentially dangerous drugs could be disastrous.
“It would be a terrible thing for our patients and their families,” Knopman said. “There is no intermediate position.”