Vinay Prasad's sur­prise re­turn to the FDA is leav­ing CBER staff won­der­ing what will hap­pen with the cen­ter's lead­er­ship af­ter sev­er­al volatile weeks.

Prasad's re­turn to the agency was an­nounced Sat­ur­day, less than two weeks af­ter he left his roles as CBER di­rec­tor and chief med­ical and sci­en­tif­ic of­fi­cer, fol­low­ing a con­tro­ver­sial stretch in­volv­ing a con­ser­v­a­tive ac­tivist cam­paign against him and the high-pro­file pull from the mar­ket (and re­turn) of Sarep­ta Ther­a­peu­tic­s' Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py Ele­v­idys.

He's been a con­tro­ver­sial fig­ure since his ap­point­ment in May, with a years­long his­to­ry of crit­i­ciz­ing the FDA and its staff for ap­proval de­ci­sions.

Pres­i­dent Don­ald Trump is mov­ing on from his Op­er­a­tion Warp Speed lega­cy.

Dur­ing his first ad­min­is­tra­tion, Trump’s health­care of­fi­cials led the spend­ing of bil­lions of dol­lars to get mR­NA vac­cines up and run­ning as fast as pos­si­ble in re­sponse to the Covid-19 pan­dem­ic, bring­ing a pow­er­ful new med­ical tech­nol­o­gy in­to the main­stream and like­ly sav­ing mil­lions of lives.

Five years lat­er, his health de­part­ment un­der HHS Sec­re­tary Robert F. Kennedy Jr. is slash­ing funds and turn­ing its back on the tech­nol­o­gy, not just for Covid but for fu­ture ap­pli­ca­tions as well.

When asked about Kennedy’s mR­NA cuts at the White House on Wednes­day, Trump praised the work of Op­er­a­tion Warp Speed as “amaz­ing,” but added, “you know that was a long time ago, and we’re on to oth­er things.”

The FDA is con­sid­er­ing re­vok­ing Pfiz­er's emer­gency use au­tho­riza­tion for its Covid-19 vac­cine for chil­dren aged 6 months through 4 years, the com­pa­ny said in a state­ment to End­points News.

"We are cur­rent­ly in dis­cus­sions with the agency on po­ten­tial paths for­ward and have re­quest­ed that the EUA for this age group re­main in place for the 2025-2026 sea­son," a Pfiz­er spokesper­son said. "It is im­por­tant to note that these de­lib­er­a­tions are not re­lat­ed to the safe­ty and ef­fi­ca­cy of the vac­cine which con­tin­ues to demon­strate a fa­vor­able pro­file."

An HHS spokesper­son told End­points the com­pa­ny's com­ment was "pure spec­u­la­tion."

Po­ten­tial changes to who can get Pfiz­er and BioN­Tech's mR­NA-based Covid vac­cine, if they go through, would align with oth­er re­cent re­stric­tions for Covid-19 shots that HHS has put in place since Robert F. Kennedy Jr. took the helm of the agency in Feb­ru­ary.

The FDA is re­strict­ing the use of blue­bird bio's rare neu­ro­log­ic dis­ease gene ther­a­py Skysona af­ter the num­ber of can­cer di­ag­noses linked to use of the treat­ment in­creased sub­stan­tial­ly in clin­i­cal tri­al par­tic­i­pants since its ini­tial 2022 ap­proval.

Skysona, a one-time gene ther­a­py that aims to slow the pro­gres­sion of neu­ro­log­ic dys­func­tion in boys 4 to 17 years of age with the rare ge­net­ic dis­ease known as ear­ly, ac­tive cere­bral adrenoleukody­s­tro­phy (CALD), can now on­ly be used in pa­tients with­out a stem cell donor or oth­er al­ter­na­tive treat­ment op­tions, FDA said.

At the time of ap­proval, blood can­cers were iden­ti­fied as a se­ri­ous risk as­so­ci­at­ed with the use of Skysona and they were first re­port­ed in three of 67 pa­tients (4%) across clin­i­cal stud­ies. That num­ber lat­er rose to sev­en pa­tients as of last Oc­to­ber.

The gov­ern­ment on Thurs­day de­feat­ed an­oth­er two le­gal chal­lenges against Medicare drug price ne­go­ti­a­tions: an ap­peals case brought by Boehringer In­gel­heim and a dis­trict court case in­volv­ing the in­dus­try trade group PhRMA.

Drug­mak­ers and oth­er or­ga­ni­za­tions have suf­fered a string of loss­es in court as they try to de­rail the ne­go­ti­a­tions. The new prices will take hold for the first time in Jan­u­ary. Like oth­er re­cent court opin­ions in the gov­ern­ment’s fa­vor, the Boehringer de­ci­sion in the US Court of Ap­peals for the Sec­ond Cir­cuit fo­cused on the “vol­un­tari­ness” of the ne­go­ti­a­tion process.

A Con­necti­cut fed­er­al judge ini­tial­ly tossed Boehringer’s case last Ju­ly, not­ing that the com­pa­ny could drop out of Medicare and Med­ic­aid if it doesn’t like the terms. But Kevin King, an at­tor­ney from Cov­ing­ton & Burl­ing who rep­re­sent­ed Boehringer, said in an oral ar­gu­ment that eco­nom­ic pres­sures give it “no choice but to ac­cept CMS’ terms."

The FDA on Thurs­day launched a new pro­gram that aims to boost do­mes­tic drug man­u­fac­tur­ing by mak­ing it eas­i­er for com­pa­nies to build fac­to­ries in the US.

The pro­gram, dubbed FDA PreCheck, is the lat­est ef­fort by the Trump ad­min­is­tra­tion to in­crease US drug pro­duc­tion. Pres­i­dent Don­ald Trump has warned that phar­ma-spe­cif­ic tar­iffs could be ar­riv­ing in the "next week or so" in a bid to en­cour­age com­pa­nies to shift their man­u­fac­tur­ing pres­ence.

"FDA PreCheck aims to sup­port faster es­tab­lish­ment of new US phar­ma­ceu­ti­cal man­u­fac­tur­ing ca­pac­i­ty through ear­li­er reg­u­la­to­ry in­put, en­hanced en­gage­ment, and ef­fi­cient CMC as­sess­ments," ac­cord­ing to a no­tice in the Fed­er­al Reg­is­ter.