The Trump administration is formally nominating a radiation oncologist to head the Food and Drug Administration while planning to shuffle leadership in preparation for what it hopes will be his confirmation.
The FDA said Friday that the current head, acting Commissioner Ned Sharpless, will return to his role as director of the National Cancer Institute, while Department of Health and Human Services assistant secretary for health Brett Giroir will temporarily take over as head of the agency, pending what the administration said it hoped would be the expeditious confirmation of Dr. Stephen Hahn, chief medical executive at the University of Texas MD Anderson Cancer Center.
Under federal law, no person can serve in an “acting” capacity for longer than 210 days, and as such, Sharpless’ tenure as acting head of the FDA ended Friday at 5 p.m.
“Under Dr. Sharpless’ leadership for the past seven months, FDA has forged ahead in its essential work of protecting the public health,” HHS Secretary Alex Azar said in a statement. “Dr. Sharpless’ willingness to step into the role of acting commissioner and to lead the team at FDA with a steady hand ensured that the agency did not miss a beat in advancing its vital mission.”
Sharpless took over following the resignation in March of Scott Gottlieb, who had led the agency since 2017.
Hahn had already been under consideration to lead the agency for a couple of months. It was initially reported in September that the administration was mulling his nomination to head the FDA. And last month, news outlets reported that Trump was on track to nominate him. Sharpless and Giroir were also reportedly under consideration.
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.
In a statement Friday, the American Society for Radiation Oncology expressed its support for Hahn’s nomination. Hahn served on ASTRO’s board of directors from 2014 until 2018, and the organization urged the Senate to “swiftly” confirm him.
“Dr. Hahn has broad knowledge as a clinician, researcher, educator and administrative leader, and he previously obtained the rank of commander in the U.S. Public Health Service,” a statement from ASTRO read. “He is well-versed on the drug, biologic and device development pipeline, demonstrated by his role in developing multiple medical products. His clinical expertise and training in internal medicine, medical oncology and radiation oncology, as well as his international recognition in treating lung cancer, give him the ability to tackle some of the toughest issues faced by the FDA.”
Issues Hahn would face as commissioner include how the agency should regulate tobacco products and electronic cigarettes, the safety of medical devices, generic drug approvals and the regulatory status of cannabidiol in foods and other products.
The Advanced Medical Technology Association offered praise to Hahn as well.
“We congratulate Dr. Hahn on his nomination to lead FDA, and we hope the Senate moves swiftly to confirm him,” AdvaMed CEO Scott Whitaker said in a statement. “Dr. Hahn’s distinguished career as a healthcare provider and researcher gives him a unique perspective on the importance of patient access to the latest medical advances.”
Photo: The University of Texas MD Anderson Cancer Center
