What To Know About Scott Gottlieb, Trump’s Nominee To Head FDA

Scott Gottlieb, MD, a resident fellow at the American Enterprise Institute and a leading conservative expert on health care policy, has been nominated by President Trump to lead the FDA, beating out Jim O’Neill, who was also in the running. O’Neill has come up with some ideas over the years that give some pause. Ideas such as allowing drug companies to simply prove that drugs are safe before they’re put on the market—not that they actually work. Also, he’s for people being allowed to sell their organs.

But Gottlieb’s nomination doesn’t exactly make those who feared O’Neill breathe sighs of relief. Not everyone thinks that Gottlieb would be that much of an improvement. (Managed Care interviewed Gottlieb last year.) David Gorski, MD, PhD, writing in the New York Times science blog recently, noted that Gottlieb holds many of the same anti-regulation views as O’Neill. Gorski added that Gottlieb seems to have turned into a “pharmaceutical shill.”

According to STAT, here are some other things you should know about Gottlieb.

  • FDA drug reviewers are pulled in two directions, Gottlieb believes. They vet clinical data and then make final decisions on applications, meaning that they face pressure to speed up the process and ensure safety. Gottlieb would change that process.
  • As it stands now, the FDA cannot say why it rejects a drug, and that allows pharmaceutical companies to publish only the positive FDA response feedback letters. Gottlieb wants all the information out there.
  • Gottlieb wants terminally ill patients to have access to experimental drugs that have not yet received full FDA approval. He’s said that the FDA is hindered by obsession with certainty.
  • Gottlieb especially wants to speed up the approval of generics. He wrote in the Wall Street Journal last year that the agency should prioritize applications for generic categories where competitors are exiting.

Source: STAT