Drew Armstrong Executive Editor, Endpoints NewsWhat FDA will we...

Drew Armstrong Executive Editor, Endpoints News What FDA will we get? President-elect Donald Trump has just set up a showdown for the future of biopharma policy during his administration. On one side is Trump’s pick to lead the Department of Health and Human Services, Robert F. Kennedy Jr. Kennedy is an anti-vaccine advocate who, at various points, has called for limiting drug ads, ending some government research on pharma treatments, and a re-review of data supporting vaccine safety. He has called the relationship between the FDA and industry corrupt, and has said that Americans take too many drugs for too little benefit. On the other side is Vivek Ramaswamy, Trump’s pick to co-lead a new Department of Government Efficiency, charged with cutting red tape across government. Ramaswamy, a pro-business libertarian, is the founder of Roivant Sciences, the source of his significant wealth. In stark contrast to Kennedy, Ramaswamy has called for less stringent reviews of drugs and faster approvals. On Friday in a social media post, the former pharma CEO said his "#1 issue with FDA is that it erects unnecessary barriers to innovation (e.g. two replicate phase 3 studies instead of one, refusal to accept valid clinical results from other nations, etc.)." The merits of Ramaswamy’s ideas aside (and the fact that in many cases, two Phase 3 trials aren’t used for approval), the two represent almost entirely different philosophies about the biopharma industry. Kennedy sees the industry as dangerous and corrupt, and in need of far greater oversight and restriction by the government. Ramaswamy appears to see the government as the problem, holding back an industry that should deal with far less interference. Those views aren’t compatible. We are in the very, very early days of the eventual Trump White House. And if there have been many constants to the volatile politics of his administration, it’s that what seems true today might not be tomorrow. A huge amount will change — people, ideas, positions, priorities. Kennedy may not survive the nomination process (he’s already generating opposition from anti-abortion advocates, and the agricultural industry allies in the Senate haven’t gotten started yet). Ramaswamy may run into the dull buzzsaw of inertia that is the US federal bureaucracy and find that making huge cuts to regulation and people is easier said than done. I don’t know how this ends. But I do know it’s far from settled. — Drew

Obviously more toward the macro side, I wonder how relevant here and how fast any variation in philosophy occurs though, favourably or otherwise.