Marie Gårdmark: “What to expect from Trump’s second term?”

President Trump’s approach to the FDA during his last term in office was characterized by a focus on deregulation, faster approvals, and lowering prices. What can we expect from the administration and specifically the Secretary of Health RF Kennedy Jr. during the upcoming years? 

Well, both RFK Jr. and President Trump have expressed a desire to eliminate the FDA user fee programs (PDUFA). They are concerned that user fees may make the FDA more susceptible to industry influence and could lead to the approval of drugs or devices that are not supported by adequate scientific evidence. That could include the modification, reframing, or potentially even elimination of the FDA’s user fee programs, which currently heavily fund many review activities at the FDA.