Sharpless selected for FDA position

WASHINGTON -- National Cancer Institute Director Norman Sharpless will become acting commissioner of the Food and Drug Administration, succeeding Scott Gottlieb, who is leaving next month, Health and Human Services Secretary Alex Azar said Tuesday.

Sharpless, 52, is an accomplished researcher, oncologist and administrator. He has been director of the cancer institute for about 18 months, earning good reviews from cancer advocates, patients groups and academic researchers. He has had a cordial relationship with Gottlieb, who supported his appointment to the FDA job. And he is a regular player in evening basketball games arranged by FDA officials.

Gottlieb surprised patients groups, health companies and members of Congress last week by saying he is resigning to spend more time with his wife and three young children, who live in Connecticut.

During his tenure, Gottlieb launched a series of ambitious public health initiatives, including a plan to make cigarettes less addictive by drastically cutting nicotine levels. But that plan and many others have barely progressed beyond the earliest stages, raising questions about their timeline and prospects for completion. FDA commissioners report to the White House but generally have broad leeway to choose their priorities.

Sharpless has publicly supported the FDA's efforts to more tightly regulate tobacco and crack down on underage vaping. E-cigarettes are generally viewed as less harmful than traditional tobacco products, but they usually contain nicotine, which can harm the adolescent brain. Some research also suggests that teenagers who use e-cigarettes are more likely to try regular cigarettes.

Azar announced Sharpless' appointment at a hearing before the House Energy and Commerce Committee's health subcommittee.

"We are going to be carrying forward Dr. Gottlieb's vision," Azar said. "His agenda is my agenda. My agenda is his agenda."

Sharpless is expected to start at the FDA within weeks. The administration has started a search for a permanent replacement to Gottlieb, and it's possible Sharpless will be considered. As a presidential appointee, Sharpless already has been extensively vetted and has divested himself of financial holdings that could pose conflicts of interest. He has not been confirmed, because the National Cancer Institute job doesn't require that.

In his relatively short tenure at the cancer institute, Sharpless pushed for increased data sharing and analysis to develop new treatments for cancer. He also pressed to modernize clinical trials and worked to increase funding for academic investigators around the country, even when that required cutting internal programs. He has co-founded two early-stage biotech companies: G1 Therapeutics, which develops cancer drugs, and HealthSpan Diagnostics, a developer of blood tests.

Sharpless was director of the University of North Carolina's Lineberger Comprehensive Cancer Center before getting the top job at the cancer institute, which is part of the National Institutes of Health. His "dynamic style, deep scientific knowledge and passion for helping patients make him an ideal next commissioner during this pivotal time for science and public health," said Ellen Sigal, chairman of the advocacy group Friends of Cancer Research.

Azar also announced that Douglas Lowy, the cancer institute's deputy director, will serve as acting director of the cancer institute -- a post he also held during President Barack Obama's administration. Lowy is known for award-winning research that led to the development of a vaccine for the human papillomavirus, which causes cervical, anal, throat and other cancers.

Sharpless said in an interview with The Washington Post last year that his frustration with inadequate cancer treatments helped fuel his interest in basic research. He became a geneticist and molecular biologist, focusing on cell division and aging. A native of Greensboro, N.C., he attended the University of North Carolina at Chapel Hill as an undergraduate and as a medical student.

Sharpless has contributed to a number of Democratic candidates, including a total of $750 to Obama's 2008 and 2012 presidential campaigns, according to Federal Election Commission records. He is not registered with any party affiliation, according to public records.

Information for this article was contributed by Matthew Perrone of The Associated Press.

Business on 03/13/2019

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