What To Know About New FDA Chief Scott Gottlieb

Scott Gottlieb, MD, was confirmed yesterday to head the FDA by a Senate vote of 57 to 42. Readers of Managed Care got some insight into Gottlieb’s priorities when we interviewed him last year.

The New York Times is reporting this morning that Gottlieb promises to “divest himself from several health care companies and recuse himself for one year from decisions involving those businesses….”

Some Democratic senators weren’t swayed. During the confirmation hearing, Sen. Patty Murray of Washington said, “He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first. I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”

Gottlieb, 44, is a resident fellow at the American Enterprise Institute and a leading conservative expert on health care policy. Gottlieb served on the advisory boards for GlaxoSmithKline and Daiichi Sankyo, as well as doing other consulting work for large drug companies.

The New York Times: “Supporters of Dr. Gottlieb’s nomination have said his business experience will serve him well as head of the FDA, and friends and associates have described him as an independent thinker who will not always side with industry.”

As we reported earlier this year, here are some other things you might want to 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 FDA response 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: New York Times