FDA Commissioner Scott Gottlieb speaks in a fireside chat at BIO 2018.
National Cancer Institute Director Norman “Ned” Sharpless will serve as acting commissioner of the Food and Drug Administration, according to an announcement by the Department of Health and Human Services.
The department announced Sharpless’s appointment as acting commissioner, to succeed outgoing Commissioner Scott Gottlieb, in a tweet Tuesday. NCI Deputy Director Doug Lowy will serve as acting director of that agency. Gottlieb abruptly announced his resignation as commissioner last week, after having denied rumors in January that he would step down.
The Wall Street Journal had reported that HHS Secretary Alex Azar favored Sharpless as Gottlieb’s successor, while Gottlieb preferred HHS Assistant Secretary Brett Giroir. Former Flatiron Health Chief Medical Officer Amy Abernethy, who was named as deputy FDA commissioner in December, was reported to be a possible candidate as interim commissioner of the agency.
Sharpless has served as NCI director since October 2017, having previously served as director of the University of North Carolina’s Lineberger Comprehensive Cancer Center, since January 2014. He received his medical degree from UNC in 1993, followed by a residency in internal medicine at the Massachusetts General Hospital and a hematology-oncology fellowship at Harvard Medical School’s Dana-Farber/Partners Cancer Care.
Gottlieb, who is expected to step down in about a month, oversaw the FDA’s embrace of numerous new technologies, including the first-ever approvals of CAR-T and gene therapies, along with the first approval of a drug with a digital tracking system. In addition, he played a significant role in strengthening the agency’s regulation of tobacco products.
Given Gottlieb’s work at the agency, finding a replacement for him could be a challenge, experts said last week. However, some important attributes for his successor to have include a clinical background, an ability to see what is possible technologically and an awareness of where various technologies can take the world, so that the US can get an edge over China and Europe, one interviewed expert said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Photo: Alaric DeArment, MedCity News
