Scott Gottlieb Resigns | Norman Sharpless Chosen As FDA Acting Director

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

The interim head will be Dr. Norman “Ned” Sharpless. His previous role was as the Head Of The National Cancer Institute. Sharpless was born in East Brunswick, New Jersey and became an Oncologist. He worked in 2002 to 2003 as the  Senior Advisor to the FDA Commissioner. Then as the FDA’s Director of Medical Policy Development in 2005 to 2007. He was known for advocacy for cancer research during his most recent 18 months as institute director. During his time at the National Cancer Institute, he was considered progressive. Specifically, undertaking high-risk research that no other organization can in the detection and treatments for cancers.

Doctor Norman Sharpless

The Legacy That Scott Gottlieb Leaves

One of the most notable attributes of Gottlieb’s leadership of the FDA has been his embrace of new technologies, in drugs and elsewhere. With him at the helm, the agency approved the first CAR-T cell therapies – Novartis’s Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel) – in 2017. That same year, it approved the first gene therapy, Spark Therapeutics’ Luxturna (voretigine neparvovec-rzyl) and also the first drug to include a digital ingestion tracking system, namely Otsuka Pharmaceutical’s Abilify MyCite. 2018 saw the first approval for a cannabis-based drug, GW Pharmaceutical’s Epidiolex (cannabidiol). Finally, the agency approved ketamine as the first new antidepressant in decades, Janssen’s Spravato (esketamine).

Gottlieb has been a public voice in support of cell and gene therapy. It is hoped Doctor Norman Sharpless will be as well, said Pratap Khedkar, managing principal for consulting firm ZS. Pointing to Gottlieb’s expectation of 10-20 new cell and gene therapy approvals by 2025. “The new commissioner could very well say, depending on priorities. Those things are very expensive and niche, so maybe they’re not such a 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.”

Sharpless was named as interim FDA head on March 12 by Health and Human Services Secretary Alex Azar. Held at a hearing before a U.S. House subcommittee. The Washington Post reports that he may be considered a candidate for permanent FDA director.