President Donald Trump is expected to name Scott Gottlieb, MD, a resident scholar with the American Enterprise Institute, to lead the FDA, according to reports. Gottlieb would replace Robert Califf, MD, who only took over the position February 2016 and stepped down less than a year later in January 2017.
Updated March 13, 2017 at 2:06 pm
President Donald Trump has named Scott Gottlieb, MD, a resident scholar with the American Enterprise Institute, as his nominee to lead the FDA. Gottlieb would replace Robert Califf, MD, who only took over the position February 2016 and stepped down less than a year later in January 2017.
Gottlieb has previously worked for the FDA as deputy commissioner of medical and scientific affairs. However, he has expressed opposition to many regulations at the agency, which could cause Democrats to hold up confirmation.
Public Citizen has come out strongly against Gottlieb. Michael Carome, MD, director of Public Citizen's Health Research Group, cited Gottlieb's ties to industry as a reason why the Senate should not confirm him.
Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients," Carome said in a statement. "The Senate must reject the nomination and demand a nominee who is better suited to protect public health."
Gottlieb has a history of working with The American Journal of Managed Care®. He was the moderator for the Oncology Stakeholder Summit, Spring 2015, and he has been a faculty member at the last 2 meetings of Patient-Centered Oncology Care® (PCOC®). At the 2016 meeting of PCOC®, Gottlieb discussed possibilities for repealing and replacing the Affordable Care Act. At the 2015 meeting, he expressed concerns that FDA efforts to regulate diagnostics would impact innovation.
As a Forbes contributor, Gottlieb has written plenty on topics that might indicate how he will run the FDA. For instance, he has written on streamlining the process when it comes to generics and he has written frequently on drug prices, advocating for the end of drug rebates and laying out his own ideas on addressing high costs.
"Enabling drugs prices to more accurately reflect the value they deliver to individual patients will also require FDA to change its own rules," he wrote in one column.