Re­volv­ing door be­tween in­dus­try and FDA con­tin­ues to spin

It’s well known that leav­ing the FDA for in­dus­try can bring a ma­jor salary bump, so it should come as no sur­prise that the num­ber of FDA em­ploy­ees mak­ing the leap in 2018 con­tin­ues to in­crease.

Biotech com­pa­ny Mod­er­na an­nounced Wednes­day that Welling­ton Sun, for­mer di­rec­tor of the Di­vi­sion of Vac­cines and Re­lat­ed Prod­uct Ap­pli­ca­tions at FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, will be their new head of vac­cine strat­e­gy and reg­u­la­to­ry af­fairs.

Last month, Patrick Frey, chief of staff at the FDA’s Of­fice of New Drugs (OND), left to join Am­gen as di­rec­tor of glob­al reg­u­la­to­ry pol­i­cy.

And for­mer OND di­rec­tor John Jenk­ins was ap­point­ed in June to the board of di­rec­tors of Cor­bus Phar­ma­ceu­ti­cals. Al­so in June, Elaine More­field, for­mer deputy of­fice di­rec­tor for re­view and ad­min­is­tra­tion at FDA, was ap­point­ed di­rec­tor of prod­uct qual­i­ty at Aclaris Ther­a­peu­tics, while Ger­ald Ma­sou­di, for­mer FDA chief coun­sel, was ap­point­ed chief le­gal of­fi­cer at Ju­ul Labs.

That news fol­lows the de­par­ture of Ga­yarti Rao, for­mer di­rec­tor of the FDA’s Of­fice of Or­phan Prod­ucts De­vel­op­ment, who moved over to Rock­et Phar­ma­ceu­ti­cals in May.

Mean­while, 20-year FDA vet­er­an Badrul Chowd­hury, most re­cent­ly di­rec­tor of the Cen­ter for Drug Eval­u­a­tion and Re­search’s (CDER) Di­vi­sion of Pul­monary, Al­ler­gy and Rheuma­tol­ogy Prod­ucts, took a job in April as se­nior vice pres­i­dent at As­traZeneca.

Sarah Pope Miksin­s­ki, for­mer di­rec­tor of the Of­fice of New Drug Prod­ucts in the FDA’s Of­fice of Phar­ma­ceu­ti­cal Qual­i­ty, left the agency in Feb­ru­ary, al­so for As­traZeneca. And in Ju­ly 2017, Ge­of­frey Kim, for­mer di­rec­tor of the FDA’s Di­vi­sion of On­col­o­gy Prod­ucts, moved to As­traZeneca to be­come its VP of on­col­o­gy and head of on­col­o­gy strate­gic com­bi­na­tions.

Jean-Marc Guet­ti­er, for­mer di­rec­tor of the FDA’s Di­vi­sion of Me­tab­o­lism and En­docrinol­o­gy Prod­ucts, left FDA in De­cem­ber 2017 for Sanofi, while Ni­raj Mehta, for­mer as­so­ciate di­rec­tor for glob­al reg­u­la­to­ry pol­i­cy at the FDA, moved over to Mer­ck as a di­rec­tor in March 2018 and Thomas Cos­grove, for­mer di­rec­tor of FDA’s Of­fice of Man­u­fac­tur­ing Qual­i­ty in the Of­fice of Com­pli­ance, left in No­vem­ber 2017 to join the law firm Cov­ing­ton & Burl­ing.

Ques­tions have been raised in re­cent years on the re­volv­ing door be­tween in­dus­try and FDA, par­tic­u­lar­ly as ex­pe­ri­ence at the agency can lead to lu­cra­tive salaries and cre­ate con­flicts where re­la­tion­ships be­tween in­dus­try and FDA are al­ready cozy.

But even for­mer FDA com­mis­sion­ers are get­ting in on the in­dus­try ac­tion. Frank Young, FDA com­mis­sion­er in the 1980s, was ap­point­ed in May as ex­ec­u­tive vice pres­i­dent of reg­u­la­to­ry af­fairs at Tis­sueTech, while Mark Mc­Clel­lan, FDA com­mis­sion­er from 2002 to 2004, was ap­point­ed to Cigna’s board of di­rec­tors in Ju­ly.

FDA did not re­spond to a re­quest for com­ment on whether there might be oth­ers who have left the agency and gone to work in in­dus­try.


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

John Hood [file photo]

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