Scott Gottlieb Resigns | Doctor Norman Sharpless Chosen as FDA Director

Scott Gottlieb was the head of the FDA for two years from May 2017 to May 2019. The FDA has now named Doctor Norman Sharpless to replace Scott Gottlieb as the acting commissioner of the Food and Drug Administration.

Doctor Norman Sharpless held a previous role as the Head Of The National Cancer Institute. Sharpless was born in East Brunswick, New Jersey, and became an Oncologist. Later, he worked from 2002 to 2003 as the Senior Advisor to the FDA Commissioner.

Then, his role as the FDA’s Director of Medical Policy Development from 2005 to 2007 showed his advocacy for cancer research. During his time at the National Cancer Institute, he was impressively progressive. Specifically, undertaking high-risk research that no other organization had in the detection and treatment of cancers.

The Legacy that Scott Gottlieb Leaves

One of the most notable attributes of Gottlieb’s leadership has been his embrace of new technologies. With Scott as the head of the FDA, the agency approved the first CAR-T cell therapies – Novartis’s Kymriah and Gilead Sciences’ Yescarta – in 2017. The first gene therapy is also approved in 2017, Spark Therapeutics’ Luxturna, which is also the first drug to include a digital ingestion tracking system.

In 2018, we saw the first approval for a cannabis-based drug, GW Pharmaceutical’s Epidiolex. Finally, the agency approved ketamine as the first new antidepressant in decades, Janssen’s Spravato.

Scott Gottlieb has been a public voice in support of cell and gene therapy. We hope that Doctor Norman Sharpless will be as well, says Pratap Khedkar, the managing principal for consulting firm ZS. Gottlieb’s expectation is 10-20 new cell and gene therapy approvals by 2025. “The new commissioner could say these things are very expensive and niche, and so maybe they’re not a top priority,” Khedkar said in a phone interview. “If you do that, then the whole cell and gene therapy scene gets a bit of a setback.”

Doctor Norman Sharpless is the interim FDA head as of March 12th. The Health and Human Services Secretary, Alex Azar presented the honor. The Washington Post reports that he will likely be considered a candidate for permanent FDA director.