20 March 2017 - President Donald Trump has made cutting back on FDA regulations a priority, but what are the potential costs?
In his 28 February speech to Congress, Trump called for “slashing the restraints” from the FDA's “burdensome” drug approval process. He pointed to a 20-year-old student who survived Pompe disease as an example of the benefits when treatment is allowed to reach patients sooner rather than later. But Duke faculty said that Trump’s efforts to slash FDA regulations could have dangerous consequences.
“The president is complaining about the FDA being slow and overly cautious, and I think the president is right about that critique of the FDA of 20 years ago, but I think that’s not true of the FDA today,” said David Ridley, faculty director of the Health Sector Management program. “In the past, the FDA was too slow approving all drugs and set too high a bar for some breakthrough drugs, but today the FDA is faster reviewing all drugs, and also gives some shortcuts to breakthrough therapies.”