Se­nate likely to con­firm Califf as FDA chief af­ter hear­ing

Modern Healthcare - - THE WEEK AHEAD - —Steven Ross John­son

Dr. Robert Califf is ex­pected to be­come the next head of the U.S. Food and Drug Ad­min­is­tra­tion even though he’s faced con­tro­versy since be­ing nom­i­nated ear­lier this year.

Califf is sched­uled to tes­tify this week be­fore the Se­nate Health, Ed­u­ca­tion, La­bor and Pen­sions (HELP) Com­mit­tee, which likely will ask about his re­ported fi­nan­cial ties with the phar­ma­ceu­ti­cal in­dus­try, among other con­cerns voiced by crit­ics.

Califf’s nom­i­na­tion to re­place Dr. Mar­garet Ham­burg, who stepped down in March af­ter six years in the role, was lauded by trade groups such as the Biotech­nol­ogy In­dus­try Or­ga­ni­za­tion and the Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion. They both cited Califf’s ex­per­tise in clin­i­cal re­search as the ba­sis for his qual­i­fi­ca­tions.

But crit­ics say Califf was paid by drug­mak­ers while serv­ing as di­rec­tor of the Duke Clin­i­cal Re­search In­sti­tute and that raises ques­tions about his abil­ity to re­main im­par­tial.

Op­po­nents in­clude Demo­cratic pres­i­den­tial can­di­date Sen. Bernie San­ders of Ver­mont, who plans to vote no. “At a time when mil­lions of Amer­i­cans can­not af­ford to pur­chase the prescription drugs they need, we need a new leader at the FDA who is pre­pared to stand up to the phar­ma­ceu­ti­cal com­pa­nies and work to sub­stan­tially lower drug prices,” San­ders has said.

New Eng­land Jour­nal of Medicine Ed­i­tor-in-Chief Dr. Jef­frey Drazen came to Califf’s de­fense last month in an ed­i­to­rial en­dors­ing his nom­i­na­tion. Still, th­ese con­tro­ver­sies are un­likely to block his con­fir­ma­tion, as a num­ber of con­ser­va­tive mem­bers of the Se­nate HELP Com­mit­tee—in­clud­ing the chair­man, Sen. La­mar Alexan­der—have voiced their sup­port.


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