FDA names new No. 2 to re­place re­tir­ing Sher­man

The US Food and Drug Ad­min­is­tra­tion (FDA) an­nounced Mon­day that Dr. Amy Aber­nethy will re­place Rachel Sher­man as Prin­ci­pal Deputy com­mis­sion­er of Food and Drugs – the high­est po­si­tion at the agency that is not a po­lit­i­cal ap­pointee.

Amy Aber­nathy

Aber­nethy is the for­mer chief med­ical of­fi­cer, chief sci­en­tif­ic of­fi­cer and se­nior vice pres­i­dent, on­col­o­gy, at Flat­iron Health, which is a unit of Roche. Pri­or to that she was a pro­fes­sor of med­i­cine at Duke Uni­ver­si­ty School of Med­i­cine and ran the Cen­ter for Learn­ing Health Care in the Duke Clin­i­cal Re­search In­sti­tute and Duke Can­cer Care Re­search Pro­gram in the Duke Can­cer In­sti­tute.

FDA Com­mis­sion­er Scott Got­tlieb wrote in a memo to FDA staff an­nounc­ing Aber­nethy’s ap­point­ment “She’s a high­ly re­gard­ed thought leader who has held nu­mer­ous po­si­tions of lead­er­ship in her fields of in­ter­est and dis­tin­guished her­self for her in­tel­lect, her pas­sion for pa­tient care and sci­ence, and her col­le­gial­i­ty.”

Ellen Si­gal, Chair and Founder of Friends of Can­cer Re­search, added: “As a treat­ing physi­cian, not on­ly does she know first-hand the im­por­tance and pow­er of the im­pact the FDA has on pa­tients every day, but she has shown in her many lead­er­ship ca­pac­i­ties that in or­der to make true ad­vances, and save lives, you must al­ways in­no­vate with the pa­tient at the fore­front. This ap­point­ment, in many ways, is a nat­ur­al pro­gres­sion from the piv­otal work that Rachel Sher­man has paved the way for since her re­turn to FDA in 2015.”

Dr. Sher­man is re­tir­ing from FDA in Jan­u­ary af­ter serv­ing at the agency since 1989. Af­ter 15 years of in­creas­ing re­spon­si­bil­i­ty in CDER, in 2005, Dr. Sher­man moved to FDA’s Of­fice of the Com­mis­sion­er, be­com­ing As­so­ci­ate Com­mis­sion­er for Clin­i­cal Pro­grams and di­rect­ing FDA’s Crit­i­cal Path Ini­tia­tive.

She lat­er re­turned to CDER in 2009 and served as CDER’s As­so­ci­ate Cen­ter Di­rec­tor for Med­ical Pol­i­cy and Di­rec­tor of the Of­fice of Med­ical Pol­i­cy, be­fore tak­ing over in her cur­rent po­si­tion af­ter a brief re­tire­ment in 2015.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

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