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Inside Health Policy – Azar Taps Nat’l Cancer Institute Director As Acting FDA Commissioner

Inside Health Policy – Azar Taps Nat’l Cancer Institute Director As Acting FDA Commissioner

National Cancer Institute Director Ned Sharpless will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).


Sharpless was among three candidates viewed as top contenders for the job, and Azar said Sharpless’ “deep scientific background and expertise will make him a strong leader for FDA,” he said.


“There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” Azar said in his opening statement at a House Energy & Commerce health subcommittee hearing on Tuesday, exactly a week after Gottlieb announced he was resigning from FDA.


Gottlieb applauded Azar’s choice, calling Sharpless “a valued colleague,” and expressing his confidence that “the transition will be seamless and the FDA will continue to secure its consumer protection role and advance policies to promote innovation and safety for families.”


True to form, Gottlieb also took to Twitter to laud Sharpless, calling him “a great public health champion,” and “a dedicated physician.” The outgoing commissioner has retweeted Sharpless several times over the past week in regards to initiatives involving cancer and diet, International Women’s Day, and the modernization of clinical trials.


A leading cancer patient advocacy group quickly voiced its approval of Sharpless. Ellen Sigal, founder and chair of Friends of Cancer Research, said her group has “no doubt that Dr. Sharpless will continue to navigate and direct the FDA in a manner that best benefits patients[.]”


Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), also praised the choice, saying Sharpless has demonstrated extraordinary leadership at NCI and has been a strong ally in the fight against cancer.

“With his exceptional perspective and experience in cancer research, Dr. Sharpless will be able to continue FDA’s work prioritizing the review and approval of innovative therapies that have the potential to cure diseases like cancer. It will also be vital that Dr. Sharpless advance and implement policies previously endorsed by outgoing-Commissioner Gottlieb aimed at curtailing the soaring rates of youth tobacco use, especially e-cigarettes,” she said.


Sharpless said taking over Gottlieb’s job and moving forward on the initiatives he put in place “will be an honor.” Douglas Lowy, the current deputy director of the NCI, will service as acting director there.


The announcement comes a day after the White House included sharp cuts to NCI’s funding in President Donald Trump’s fiscal 2020 budget request. The budget calls for cutting NCI’s budget by $897 million from fiscal 2019 levels, for a total of about $5.25 billion in fiscal 2020.


Prior to heading NCI, Sharpless served as director of the University of North Carolina Lineberger Comprehensive Cancer Center. Sharpless’ profile on NCI’s website says he has authored more than 150 original scientific papers, reviews, and book chapters, and is an inventor on 10 patents.


Sharpless also cofounded two clinical-stage biotechnology companies: G1 Therapeutics and HealthSpan Diagnostics, and is chief of the Aging Biology and Cancer Section at the National Institute on Aging’s Laboratory of Genetics and Genomics.


Michael Carome, head of Public Citizen’s Health Research Group, pointed out to Inside Health Policy that Sharpless, due to his background as an academic, has taken far less funding from industry than that taken by Gottlieb.


According to CMS’ Open Payments listing, Sharpless took $5,447.43, in consulting, travel, lodging and food and beverage fees from Pfizer in 2016. In 2015 and 2013, he took $65.38 and $81.80, respectively, in food and beverage fees from and Pharmacyclics LLC and Sanofi-Aventis, respectively.


In comparison, Gottlieb took payments of $15,000, $145,357.92 and $199,989.67 from industry, mostly in the form of consulting fees, in 2017, 2016 and 2015, respectively.


Another candidate that had been rumored to be in line for the top FDA position was FDA Principal Deputy Commissioner Amy Abernathy.…