President 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 (read “Trump Promises Big Pharma ‘Fantastic’ FDA Leadership & Less Regulation”; http://sco.lt/5SVFVh).
But does anyone really want a deregulated FDA?
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 (read “Trump ‘Putin-ative’ Candidate for FDA Leader Would Have Converted Agency to ‘Yelp for Drugs’”; http://sco.lt/8q2m0X). 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.
In his meeting with pharma executives Tuesday, Trump pledged not just to clear away regulations but to support fledgling startups seeking to get drugs approved.
Yet it’s not clear his reforms would actually benefit small companies.
In a world where the FDA approved medications on scant data, pharma’s wealthiest giants could litter the market with dubious new drugs — and flood the airwaves with ads touting them. That would crowd out upstart competitors and kill a whole industry’s incentive to try new things.