A day af­ter Sen. Bill Cas­sidy (R-LA) called for a de­lay to this week’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing, HHS chief Robert F. Kennedy Jr. said he did not guar­an­tee to pre­serve the vac­cine ad­vi­so­ry pan­el's ros­ter to re­ceive the sen­a­tor’s sup­port for his con­fir­ma­tion.

Kennedy on Tues­day told the House En­er­gy and Com­merce Sub­com­mit­tee on Health that he did not tell Cas­sidy he wouldn’t change the make­up of ACIP while vy­ing for the top fed­er­al health post in late Jan­u­ary. His an­swer was in re­sponse to Rep. Kim Schri­er (D-WA), who asked for clar­i­ty on what guar­an­tees Cas­sidy se­cured when he an­nounced in a Feb­ru­ary floor speech that he would back Kennedy’s nom­i­na­tion.

HHS Sec­re­tary Robert F. Kennedy Jr. on Tues­day promised that the US will re­main the leader in biotech in­no­va­tion, even as Chi­na has added "huge amounts of mon­ey in­to this space."

Speak­ing be­fore the House En­er­gy and Com­merce Sub­com­mit­tee on Health, Kennedy said he met re­cent­ly and "re­peat­ed­ly" with the biotech in­dus­try to re­as­sure them that the thou­sands of April staff cuts at the FDA won't af­fect their drug re­view time­lines.

The com­ments show the ex­tent to which Kennedy's stance on the in­dus­try is shift­ing. "The mis­sion to Make Amer­i­ca Healthy Again (MA­HA) in­cludes MA­BA — Make Amer­i­can Biotech Ac­cel­er­ate," he wrote last Fri­day on X, for­mer­ly known as Twit­ter.

But for decades, Kennedy has fierce­ly crit­i­cized vac­cines and con­flicts be­tween the bio­phar­ma in­dus­try and gov­ern­ment em­ploy­ees.

Mul­ti­ple agency sources said FDA Com­mis­sion­er Mar­ty Makary was be­hind a short-lived re­quest last week to re­ject a rare dis­ease drug ap­pli­ca­tion from KalVista Phar­ma­ceu­ti­cals that re­mains un­der agency re­view.

The re­jec­tion re­quest was un­suc­cess­ful, as se­nior FDA sci­en­tists pushed back in­ter­nal­ly and raised le­gal con­cerns that such an ac­tion would be “ar­bi­trary and capri­cious,” ac­cord­ing to in­ter­nal mes­sages re­viewed by End­points News. Even still, the pur­port­ed at­tempt by the po­lit­i­cal­ly ap­point­ed head of the agency to in­ter­vene in the FDA’s typ­i­cal re­view process was de­scribed by three FDA sources with knowl­edge of the mat­ter as ex­tra­or­di­nary in­ter­fer­ence in­to the agency’s day-to-day op­er­a­tions. The sources spoke with End­points on the con­di­tion of anonymi­ty. An HHS spokesper­son de­nied such a re­quest was made by FDA lead­er­ship.

The FDA is bring­ing back Michael Davis as the next deputy di­rec­tor of the Cen­ter for Drug Eval­u­a­tion and Re­search, ac­cord­ing to an in­ter­nal memo viewed by End­points News.

Davis’ hir­ing comes a day af­ter the FDA’s top drug reg­u­la­tor, Jacque­line Cor­ri­g­an-Cu­ray, an­nounced she is re­tir­ing from the agency in Ju­ly. Davis is set to fill the No. 2 po­si­tion at CDER. Jour­nal­ist Der­rick Gin­gery first re­port­ed Davis' hir­ing on X on Tues­day af­ter­noon.

The agency has not yet named a suc­ces­sor to Cor­ri­g­an-Cu­ray, who has been the act­ing di­rec­tor of CDER since Pa­trizia Cavaz­zoni stepped down in Jan­u­ary. Bio­Cen­tu­ry re­port­ed last week that for­mer phar­ma­ceu­ti­cal ex­ec­u­tive Karim Mikhail, who cur­rent­ly serves as an ad­vi­sor to FDA Com­mis­sion­er Mar­ty Makary, could be the next CDER di­rec­tor.

Mikael Dol­sten, Pfiz­er's for­mer chief sci­en­tif­ic of­fi­cer who led the com­pa­ny’s Covid-19 vac­cine de­ve