Rick Paz­dur, the head of the FDA's drug of­fice, is ex­pect­ed to leave the agency less than a month af­ter step­ping in­to the role.

His ex­it comes af­ter he was per­son­al­ly lob­bied by Com­mis­sion­er Mar­ty Makary to take the job, and was giv­en as­sur­ances that he would be shield­ed from some of the chaot­ic dy­nam­ics that have af­fect­ed oth­er parts of the FDA, ac­cord­ing to pre­vi­ous re­port­ing by End­points News.

But he quick­ly clashed with Makary over a new Na­tion­al Pri­or­i­ty Vouch­er pi­lot pro­gram, say­ing that it may be il­le­gal. And he pushed back on at­tempts by Makary’s re­quests for la­bel changes and to pull cer­tain un­spec­i­fied drugs, End­points has re­port­ed.

A top FDA of­fi­cial's claim that Covid vac­cines caused at least 10 deaths in chil­dren has yet to be backed up by the da­ta that typ­i­cal­ly ac­com­pa­ny ma­jor safe­ty an­nounce­ments, in­clud­ing de­tails of the al­leged deaths, which vac­cines were used, and case re­ports that could help clin­i­cians and re­searchers make their own as­sess­ments.

The claim, made in a lengthy email to staff on Fri­day by CBER Di­rec­tor Vinay Prasad, de­scribes the al­leged deaths as "a pro­found rev­e­la­tion" about the safe­ty of the shots. It al­so calls for sig­nif­i­cant changes to the reg­u­la­tion of child­hood vac­cine ap­provals, and comes just days be­fore HHS Sec­re­tary Robert F. Kennedy Jr.'s hand­picked group of CDC ad­vi­sors will dis­cuss the child­hood vac­cine sched­ule — and po­ten­tial­ly rec­om­mend changes to the prac­tice of giv­ing the he­pati­tis B vac­cine soon af­ter birth.

De­tails from an in­ves­ti­ga­tion by CBER Di­rec­tor Vinay Prasad in­to 10 al­leged child deaths re­lat­ed to Covid-19 vac­cines won't be com­ing soon, an FDA spokesper­son told End­points News on Wednes­day.

FDA spokesper­son Caleb Michaud said the agency was not re­leas­ing any more de­tails in the "near term," since "there are ad­di­tion­al ad­verse event cas­es be­ing in­ves­ti­gat­ed." Michaud did not say what those ad­verse events were, or if they were deaths.

Late last week, Prasad sent an in­ter­nal email to CBER staff claim­ing that 10 vac­cine-re­lat­ed deaths were un­cov­ered by “an ini­tial analy­sis of 96 deaths be­tween 2021 and 2024.” The email was re­port­ed by End­points News and oth­er me­dia out­lets, but the agency has not made any of­fi­cial pub­lic state­ments, un­like in past in­stances when it has in­ves­ti­gat­ed sig­nif­i­cant safe­ty risks where it felt a need to in­form the pub­lic and med­ical pro­fes­sion­als.

The gov­ern­ment on Tues­day an­nounced fi­nal prices for the sec­ond round of drugs ne­go­ti­at­ed by Medicare un­der the In­fla­tion Re­duc­tion Act, in­clud­ing for No­vo Nordisk’s block­buster semaglu­tide prod­ucts Ozem­pic and We­govy.

The ne­go­ti­at­ed prices are up to 85% low­er than the list prices for the drugs.

The an­nounce­ment gives the first sub­stan­tive look at how IRA ne­go­ti­a­tions tran­spired un­der the Trump ad­min­is­tra­tion, which has pledged to use mul­ti­ple ap­proach­es to low­er drug prices. CMS said it ac­cept­ed drug­mak­ers’ re­vised coun­terof­fers for sev­en of the drugs.

The gov­ern­ment said that when the prices take ef­fect in 2027, pa­tients en­rolled in Medicare pre­scrip­tion drug cov­er­age will save an es­ti­mat­ed $685 mil­lion in out-of-pock­et costs. If the ne­go­ti­at­ed prices had tak­en ef­fect in 2024, CMS es­ti­mates that they would have saved Medicare $12 bil­lion in net pre­scrip­tion drug costs. That fig­ure doesn’t ac­count for  spend­ing on the Cov­er­age Gap Dis­count Pro­gram, which end­ed in 2025. When tak­ing that pro­gram in­to ac­count, es­ti­mat­ed sav­ings would have been about $8.5 bil­lion.

The new leader of the CD­C's flag­ship vac­cine ad­vi­so­ry group re­cent­ly claimed that Covid-19 vac­cines were re­spon­si­ble for a rise in can­cer cas­es, and that the vast ma­jor­i­ty of women who get the vac­cine in their first trimester have mis­car­riages.

The com­ments by Kirk Mil­hoan, who serves as chair­man of the CD­C's Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, were made at a Texas church and post­ed on YouTube in Oc­to­ber. Mil­hoan al­so com­pared pan­dem­ic-era vac­ci­na­tion record cards to Jews who were forced to wear spe­cif­ic arm­bands dur­ing the Holo­caust.

"And what they said is, if you did­n't get the vac­cine, then you were dirty, right? So that brings up all the is­sues of what hap­pened when the Jews had to wear the yel­low Star of David, right? They were the dirty ones," he said in the video.