The de­ci­sion by the FDA on Wednes­day to re­verse course and re­view Mod­er­na's flu vac­cine ap­pli­ca­tion was the re­sult of a meet­ing Tues­day be­tween an un­usu­al group of se­nior FDA lead­ers and Mod­er­na, with the FDA lead­ers walk­ing back their boss’ over­rul­ing, ac­cord­ing to two sources fa­mil­iar with the meet­ing.

The re­ver­sal was not based on pre­vi­ous da­ta or the new sub­mis­sion, ac­cord­ing to an FDA se­nior leader with di­rect knowl­edge of Mod­er­na's ap­pli­ca­tion. In the meet­ing, three se­nior lead­ers in the agen­cy's Of­fice of Vac­cines Re­search and Re­view, in­clud­ing the of­fice di­rec­tor David Kaslow, walked back their refuse-to-file (RTF) let­ter sent last week. CBER Di­rec­tor Vinay Prasad had over­ruled Kaslow and re­view staff in mak­ing the de­ci­sion to is­sue the let­ter.

Mod­er­na said that the FDA will re­view the com­pa­ny’s flu vac­cine af­ter all, now that the two sides agreed to an amend­ed fil­ing.

The com­pa­ny said Wednes­day that fol­low­ing a type A meet­ing with US reg­u­la­tors, it will ap­ply for stan­dard ap­proval in the 50 to 64 age group and ac­cel­er­at­ed ap­proval in adults 65 and old­er. It will con­duct a post-mar­ket­ing study in the old­er age group to pro­duce ad­di­tion­al clin­i­cal da­ta. The FDA set an Aug. 5 dead­line to de­cide on both sub­mis­sions, and if ap­proved, Mod­er­na said mR­NA-1010 could be avail­able for the up­com­ing flu sea­son.

Vinay Prasad, the head of the FDA’s vac­cines and bi­o­log­ics of­fice, is back in the news af­ter his con­tro­ver­sial de­ci­sion to re­ject Mod­er­na’s flu vac­cine, as well as al­le­ga­tions in the Wall Street Jour­nal that he is fac­ing mul­ti­ple per­son­nel com­plaints in­side the agency.

Ac­cord­ing to the WSJ, Prasad has been the sub­ject of in­ter­nal com­plaints that in­clude “sex­u­al ha­rass­ment, re­tal­i­a­tion against sub­or­di­nates and ver­bal­ly be­rat­ing staff.” The WSJ cit­ed un­named sources, who al­so de­scribed sub­stan­tial trav­el ex­pens­es in­curred by Prasad.

A se­nior FDA leader who re­quest­ed anonymi­ty told End­points News that Prasad has as­signed cer­tain sub­or­di­nates mean­ing­less tasks and has ver­bal­ly at­tacked staff.

Prasad didn’t re­spond to a re­quest for com­ment, and HHS and FDA al­so didn’t re­spond.

The re­jec­tion of Disc Med­i­cine’s rare dis­ease treat­ment marks the first neg­a­tive out­come of the FDA's con­tro­ver­sial vouch­er pro­gram and sug­gests drugs that are se­lect­ed won't be guar­an­teed an ap­proval.

Dis­c's bitop­er­tin was an ear­ly test case of the Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er (CN­PV) pro­gram, a pi­lot that aims to sig­nif­i­cant­ly short­en the typ­i­cal 10- to 12-month re­view times. The FDA said in a com­plete re­sponse let­ter from Fri­day that it had ques­tions about the bio­mark­er in­tend­ed to be used for ac­cel­er­at­ed ap­proval.

An­a­lysts viewed the re­jec­tion as a sur­prise, par­tic­u­lar­ly since Disc was one of the first com­pa­nies to get the vouch­er.

Drug com­pa­nies and in­dus­try groups are push­ing back on the Trump ad­min­is­tra­tion’s pro­pos­als to make it eas­i­er for more pre­scrip­tion drugs to be avail­able over the counter.

While tout­ed by FDA Com­mis­sion­er Mar­ty Makary as a way to low­er drug costs and in­crease ac­cess, in­dus­try — in com­ments sub­mit­ted this month to the agency — is mak­ing clear that the prices of OTC drugs may eclipse gener­ic drug prices, es­pe­cial­ly as in­sur­ance is of­ten not ac­cept­ed for OTC drugs.

“De­spite FDA’s in­tent to de­crease costs and in­crease ac­cess to med­ica­tions, the shift of many pre­scrip­tion drugs to non­pre­scrip­tion sta­tus could ac­tu­al­ly in­crease costs to pa­tients, there­by de­creas­ing pa­tient ac­cess to treat­ments,” the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines, the gener­ic in­dus­try group, said in a com­ment from Feb. 2.

Ab­b­Vie is su­ing CMS for pick­ing Botox for the third round of Medicare ne­go­ti­a­tions, mak­ing it the first drug­mak­er to chal­lenge the up­com­ing cy­cle in court.

In a law­suit filed Wednes­day in Wash­ing­ton, DC, Ab­b­Vie said plas­ma-de­rived prod­ucts are meant by law to be ex­clud­ed from IRA ne­go­ti­a­tions. The com­pa­ny ar­gued that be­cause its Botox prod­ucts con­tain hu­man serum al­bu­min, which is sourced from donor plas­ma, “CMS has no au­thor­i­ty” to se­lect it.

HHS did not im­me­di­ate­ly re­spond to a re­quest for com­ment.

Ab­b­Vie al­so ar­gued due process and free speech vi­o­la­tions, and said the ne­go­ti­a­tion process would amount to a tak­ing of its prop­er­ty with­out just com­pen­sa­tion. The com­pa­ny asked the court to set aside Botox’s se­lec­tion for ne­go­ti­a­tions and block CMS from “ap­ply­ing the drug-pric­ing pro­vi­sions of the IRA to Botox.”