A Call For The FDA To Raise The Bar For Clinical Trials Is Flawed

As the new Trump administration begins to take shape, there are concerns that new leadership at the FDA will call for less bureaucracy and red tape, thereby lowering the bar for new drugs approvals. The view is that onerous regulations are preventing life-saving medications from getting to those who most need them. Lowering the standards for drug approvals may indeed allow for earlier patient access to drugs but, as has been discussed here in the past, liberalization of current regulations would be a mistake.