The FDA's vac­cines and bi­o­log­ics chief Vinay Prasad over­rode the agen­cy's vac­cine re­view­ers for a third time in re­cent weeks, when he nar­rowed the ap­proval of Mod­er­na’s Covid-19 shot to a small­er pop­u­la­tion of young chil­dren, ac­cord­ing to a re­cent­ly pub­lished doc­u­ment.

Prasad's ac­tion, out­lined in a Ju­ly 9 memo re­leased by the FDA, is the lat­est in­stance of Prasad dis­agree­ing with the pro­fes­sion­al staff who re­view ap­pli­ca­tions and whose rec­om­men­da­tions have in the past large­ly been signed off on by top agency of­fi­cials.

Prasad wrote in the memo that he and his of­fice did not feel there was a net clin­i­cal ben­e­fit to vac­ci­nat­ing healthy chil­dren with Mod­er­na's shot. But he said there is a ben­e­fit for chil­dren who are at high­er risk of se­vere dis­ease, so the shot was ap­proved for chil­dren 6 months through 11 years old who are at risk of more se­vere dis­ease.

West Vir­ginia’s near-to­tal abor­tion ban doesn’t con­flict with the FDA’s au­thor­i­ty to reg­u­late mifepri­s­tone, a fed­er­al ap­peals court ruled Tues­day in a case against the gener­ic abor­tion pill mak­er.

The rul­ing by the US Court of Ap­peals for the Fourth Cir­cuit sheds light on the in­ter­play be­tween fed­er­al and state pow­er over abor­tion pill ac­cess. The case is one of sev­er­al mak­ing its way through the courts that in­volve as­pects of the FDA’s safe­ty pro­gram for the drug.

Cir­cuit Judge J. Harvie Wilkin­son wrote that the states have long reg­u­lat­ed abor­tion, and that West Vir­ginia’s law doesn’t pre­empt FDA reg­u­la­tions be­cause they “op­er­ate in dif­fer­ent fields.” West Vir­ginia’s law re­stricts the “in­ci­dence of abor­tion,” while the FDA reg­u­lates how mifepri­s­tone must be pre­scribed and dis­pensed when cho­sen and le­gal for use.

The FDA is ques­tion­ing whether GSK has done enough to show that Blenrep should re­turn to the mar­ket as a sec­ond-line mul­ti­ple myelo­ma treat­ment ahead of a Thurs­day ad­vi­so­ry com­mit­tee meet­ing.

Agency brief­ing doc­u­ments re­leased Tues­day show the ex­tent to which a come­back for Blenrep, al­so known as be­lan­tam­ab mafodotin, does not seem straight­for­ward in the US fol­low­ing a re­turn to the UK mar­ket in April. The FDA raised con­cerns about tox­i­c­i­ties and the pro­posed dose of Blenrep.

"Con­sid­er­ing the ob­served ef­fi­ca­cy re­sults, safe­ty and tol­er­a­bil­i­ty con­cerns, and un­cer­tain­ties re­gard­ing the ap­pro­pri­ate­ness of the pro­posed dosages, the ben­e­fit-risk pro­file of be­lan­tam­ab mafodotin for the pro­posed in­di­ca­tions, based on the DREAMM-7 and DREAMM-8 stud­ies, re­mains un­clear," the FDA said.

Bris­tol My­ers Squibb is call­ing for trans­paren­cy in drug price talks if the gov­ern­ment se­lects prod­ucts for rene­go­ti­a­tion un­der the In­fla­tion Re­duc­tion Act, cau­tion­ing against “in­dis­crim­i­nate use” of the process.

The phar­ma gi­ant’s com­ments re­flect drug­mak­ers’ gen­er­al op­po­si­tion to Medicare price ne­go­ti­a­tions with the sec­ond round un­der­way. Bris­tol My­ers was one of sev­er­al com­pa­nies to chal­lenge the ne­go­ti­a­tions in court, and its case is now on ap­peal in the Third Cir­cuit.

CMS should pro­vide “the max­i­mum lev­el of flex­i­bil­i­ty and trans­paren­cy in im­ple­ment­ing this new rene­go­ti­a­tion process,” Bris­tol My­ers said in a com­ment made pub­lic on Tues­day. It al­so urged the gov­ern­ment to “con­sid­er the full cost of rene­go­ti­at­ing” drug prices reached dur­ing the first two rounds of ne­go­ti­a­tions.