Vinay Prasad's sec­ond ex­it from FDA lead­er­ship af­ter less than a year in his po­si­tions did­n't come as a ma­jor sur­prise. But with his two po­si­tions now left to fill — as the di­rec­tor of CBER and as chief med­ical and sci­en­tif­ic of­fi­cer — there are ques­tions about the agen­cy's fu­ture di­rec­tion with vac­cine and rare dis­ease drug re­views.

Hailed as a ge­nius by FDA Com­mis­sion­er Mar­ty Makary, Prasad left amid a se­ries of mis­steps over the last few weeks that in­clud­ed hold­ing a press con­fer­ence — on back­ground as a "se­nior of­fi­cial" but now wide­ly and pub­licly named as Prasad — on a drug ap­pli­ca­tion that's still un­der re­view, and walk­ing back a refuse-to-file let­ter for Mod­er­na's flu vac­cine in Feb­ru­ary that fu­eled frus­tra­tion at the White House.

A se­nior FDA of­fi­cial told re­porters Thurs­day that the ad­vi­so­ry com­mit­tees the agency has used for years to gath­er out­side per­spec­tive are “cost­ly,” “slow” and use “pomp and flash in­stead of sci­en­tif­ic truth.”

The FDA has pre­vi­ous­ly raised some ques­tions about ad­comms dur­ing the Biden ad­min­is­tra­tion. But the new, harsh crit­i­cism comes dur­ing a time when some of the agen­cy's de­ci­sions have be­come more opaque, and com­pa­nies have raised con­cerns about shift­ing agency stan­dards. Staff re­view­er­s' judg­ments have some­times been over­ruled from the top.

Thurs­day's com­ments by the se­nior of­fi­cial were part of a for­mal press brief­ing, but re­porters were not al­lowed to quote the of­fi­cial by name. The brief­ing was called not long af­ter the agency told uniQure that it would like­ly have to run a new, place­bo-con­trolled tri­al for its Hunt­ing­ton's dis­ease gene ther­a­py. The com­pa­ny has said this was a re­ver­sal from what it had pre­vi­ous­ly been told by the agency.

A new bonus pi­lot pro­gram meant to re­ward fast-work­ing FDA re­view­ers will be fund­ed in part by mon­ey from in­dus­try user fees, the first de­tails on how Com­mis­sion­er Mar­ty Makary plans to fi­nance the in­cen­tive, sources and gov­ern­ment spokes­peo­ple told End­points News.

Get­ting drug ap­pli­ca­tions re­viewed on time is one of the FDA’s most close­ly watched met­rics. Sources fa­mil­iar with the in­cen­tive pro­gram, speak­ing on the con­di­tion of anonymi­ty, said that the mon­ey from user fees is avail­able be­cause of ex­ist­ing staffing short­ages at the FDA af­ter last year's job cuts. Drug de­vel­op­ers pay an­nu­al and ap­pli­ca­tion-re­lat­ed fees to the agency, which help pay for staff that re­view those prod­ucts.

The FDA ap­proved John­son & John­son's mul­ti­ple myelo­ma com­bo treat­ment Tec-Dara for pa­tients who've al­ready had at least one line of ther­a­py.

It's the third ap­proval un­der the agen­cy's Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er (CN­PV) pi­lot, Com­mis­sion­er Mar­ty Makary's high­ly pro­mot­ed pro­gram to award rapid re­views to a hand­ful of drugs that fit FDA-picked cri­te­ria such as ur­gent pub­lic health needs or boost­ing US man­u­fac­tur­ing.

Tec-Dara is a com­bi­na­tion of Tec­vayli, a BC­MAx­CD3 bis­pe­cif­ic an­ti­body, and Darza­lex, an an­ti-CD38 mon­o­clon­al an­ti­body. Used to­geth­er, they re­duced the risk of dis­ease pro­gres­sion or death by 83% rel­a­tive to the stan­dard-of-care con­trol arm, the FDA said.

The ex­pe­dit­ed ap­proval came about 55 days af­ter J&J filed its ap­pli­ca­tion, and about three months af­ter the FDA learned about pos­i­tive re­sults from a Phase 3 clin­i­cal tri­al.

The FDA ap­proved the now-gener­ic drug leu­cov­orin to treat pa­tients with a form of cere­bral fo­late de­fi­cien­cy, sat­is­fy­ing a month­s­long ef­fort to widen the drug’s use for a con­di­tion with symp­toms that can re­sem­ble a form of autism.

But the agency did not re­ly on ad­di­tion­al clin­i­cal da­ta, and com­ments made by two se­nior FDA of­fi­cials on a press call Mon­day sug­gest­ed the ap­pli­ca­tion was giv­en the kind of per­mis­sive, flex­i­ble re­view that oth­er drug­mak­ers have been hope­ful for — but not grant­ed — un­der the cur­rent agency lead­er­ship.

Tues­day's ap­proval was tech­ni­cal­ly giv­en to GSK, the orig­i­nal mak­er of leu­cov­orin be­fore it went gener­ic. Of­fi­cials at the FDA said the la­bel change will trick­le down to gener­ic com­pa­nies that are pro­duc­ing it now that GSK no longer does.