FDA Commissioner Resigns
On March 5th, 2019 Scott Gottlieb unexpectedly resigned from his role as the commissioner for the Food and Drug Administration
Scott Gottlieb is a physician and public health advocate who was appointed the 23rd commissioner of the Food and Drug Administration in May of 2017. However, he recently announced his resignation, effective at the end of March 2019. He gave family and commuting as his reason for resigning as his family remained in Connecticut since he took office in DC two years ago.
During his time in office, Gottlieb was known for his aggressive efforts to regulate tobacco as well as increase access and lower cost of medicines. Under his leadership the FDA approved a record number of generic medicines, new drugs and medical devices while also speaking out against the opioid crisis.
Gottlieb’s resignation came as a surprise and many are questioning what effects it may have on the healthcare industry. Let’s look at some of the possible effects his resignation could have on the industry.
Stock Price Fall
Shortly after Gottlieb made his resignation announcement, stock prices fell for biotechnology. The commissioner was widely respected in the industry and his resignation is seen as a negative for biopharma. During his time in office he approved a record number of new and generic drugs which was a great stride for companies trying to get drugs out to the market, as well as increasing access to the public.
Questions on tobacco
The initiative Gottlieb was most known for during his office were his efforts to regulate the tobacco industry. Two of the efforts he was working on against tobacco were to reduce the level of nicotine in cigarettes to a non-addictive level, as well as putting a ban on the use of menthol in cigarettes. With his resignation many industry experts have reported that those efforts will now likely end and not be pushed forward. He was also working on regulating the use of e-cigarettes by minors, another regulation that may be left unfinished due to his early resignation.
Who is Taking Over?
Following Gottlieb’s resignation announcement, Norman “Ned” Sharpless was appointed acting FDA commissioner. Sharpless is an accomplished researcher, oncologist and administrator, he has most recently been the Director of the National Cancer Institute. While with the NCI, Sharpless has worked to modernize clinical trials and increase funding for academic investigators. Prior to his tenure at the Cancer Institute he founded two early-stage biotech companies and was the Director at the Lineberger Comprehensive Cancer Center. Cancer experts and advocates have praised his appointment as the acting commissioner. It is reported that Gottlieb recommended Sharpless as his replacement and tweeted that he is delighted by his appointment.
What is Next?
Alex Azar, Health and Human Services Secretary has made several statements about the agency continuing under Gottlieb’s mission even after his departure: “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” Azar said.
“We are going to be carrying forward Dr. Gottlieb’s vision. His agenda is my agenda. My agenda is his agenda.”
Next Commissioner
The commissioner is the FDA’s top official and must be nominated by the President, then confirmed by the Senate. The administration has started the search for a permanent replacement commissioner. Sharpless will be considered for the role. He is a great candidate and has already been extensively vetted and divested any conflicting holdings.
For more information please visit:
https://www.nytimes.com/2019/03/05/health/scott-gottlieb-resigns-fda.html
https://www.fda.gov/aboutfda/centersoffices/ucm557569.htm
https://www.nbcnews.com/health/health-news/nih-cancer-chief-serve-acting-fda-commissioner-n982416