The fu­ture of an ad­vi­so­ry pan­el that re­ports to the HHS sec­re­tary on vac­cine in­jury com­pen­sa­tion ap­pears to be in lim­bo af­ter some mem­bers were told they were be­ing re­moved.

At least two mem­bers of the Ad­vi­so­ry Com­mis­sion on Child­hood Vac­cines re­ceived mes­sages say­ing their ser­vice was no longer re­quired, with no ad­di­tion­al de­tails, sources fa­mil­iar with the de­ci­sion told End­points News. The pan­el is made up of health pro­fes­sion­als, rep­re­sen­ta­tives for vac­cine-in­jured chil­dren, coun­sel for vac­cine mak­ers, and mem­bers of the gen­er­al pub­lic.

A spokesper­son for HHS did­n't re­spond to a re­quest for com­ment by the time of pub­li­ca­tion.

The pan­el had been side­lined ef­fec­tive­ly for all of last year, af­ter orig­i­nal­ly hav­ing a planned meet­ing in late Jan­u­ary 2025 post­poned in­def­i­nite­ly fol­low­ing the pres­i­den­tial in­au­gu­ra­tion. That meet­ing was then resched­uled for the mid­dle of De­cem­ber, be­fore be­ing resched­uled once more to the Mon­day af­ter Christ­mas.

The FDA is ex­tend­ing its re­view of Tra­vere’s drug for a rare kid­ney dis­or­der by three months.

The agency was ex­pect­ed to de­cide by to­day on Travere's ap­pli­ca­tion to mar­ket Filspari in fo­cal seg­men­tal glomeru­loscle­ro­sis, or FS­GS. The date has now been ex­tend­ed to April 13 af­ter the com­pa­ny sub­mit­ted new re­spons­es at the FDA's re­quest "to fur­ther char­ac­ter­ize the clin­i­cal ben­e­fit of Filspari," Tra­vere said Tues­day.

The agency re­quest­ed no ad­di­tion­al safe­ty or man­u­fac­tur­ing da­ta, the com­pa­ny said.

The De­part­ment of Com­merce ap­pears to have con­clud­ed its Sec­tion 232 in­ves­ti­ga­tion in­to phar­ma­ceu­ti­cal im­ports, ac­cord­ing to a new doc­u­ment re­viewed by End­points News.

The doc­u­ment, ti­tled a “Let­ter of Agree­ment,” ap­pears to be the lat­est frame­work for the "most fa­vored na­tion" drug pric­ing deals be­tween phar­ma com­pa­nies and the gov­ern­ment. Un­der those deals, drug­mak­ers have agreed to price cuts in ex­change for a re­prieve from tar­iffs, which could fol­low from the Com­merce De­part­men­t's 232 probe.

The doc­u­ment states that “Com­merce has con­duct­ed an in­ves­ti­ga­tion pur­suant to Sec­tion 232 of the Trade Ex­pan­sion Act of 1962 on phar­ma­ceu­ti­cal prod­ucts and their in­gre­di­ents.” A pre­vi­ous ver­sion of the frame­work, ob­tained by End­points last month, had said that the Com­merce De­part­ment "is con­duct­ing an in­ves­ti­ga­tion."

The FDA asked No­vo Nordisk and Eli Lil­ly to re­move warn­ings about sui­ci­dal ideation or be­hav­ior from the la­bels of their block­buster GLP-1 weight loss drugs.

Novo's Sax­en­da and We­govy, as well as Lil­ly's Zep­bound, were sin­gled out for la­bel up­dates fol­low­ing "a com­pre­hen­sive FDA re­view" that found no in­creased risk of such sui­ci­dal ten­den­cies. The agency said Tues­day it wants to "en­sure con­sis­tent mes­sag­ing," since la­bels on oth­er GLP-1s that were ap­proved to im­prove blood sug­ar con­trol or di­a­betes com­pli­ca­tions don't cur­rent­ly de­scribe a risk of SI/B.

Clin­i­cal tri­al da­ta found no as­so­ci­a­tion be­tween the use of GLP-1s and sui­ci­dal thoughts and ac­tions, the FDA said, while not­ing a few in­stances were ob­served in in­di­vid­ual tri­als. FDA said its com­pre­hen­sive meta-analy­sis of 91 place­bo-con­trolled clin­i­cal tri­als across GLP-1 de­vel­op­ment pro­grams "did not show an in­creased risk for SI/B or for oth­er rel­e­vant psy­chi­atric ad­verse events such as anx­i­ety, de­pres­sion, ir­ri­tabil­i­ty, or psy­chosis."