FDA Com­mis­sion­er Mar­ty Makary is call­ing for a seem­ing­ly un­prece­dent­ed idea of dan­gling the promise of speedy re­views for ex­per­i­men­tal med­i­cines in ex­change for drug­mak­ers vow­ing to low­er US drug prices.

The idea, float­ed by Makary in re­cent me­dia in­ter­views, rais­es many ques­tions about how it could be im­ple­ment­ed, as well as its le­gal­i­ty.

Last month, the FDA an­nounced a new ul­tra-fast-re­view pi­lot pro­gram that aims to re­view some new "na­tion­al pri­or­i­ty" drugs in just one or two months, down from the typ­i­cal 10 to 12 months. These are dif­fer­ent than pri­or­i­ty re­view vouch­ers, which cut re­view time­lines to six months. The FDA has shared few de­tails about the new pro­pos­al, known as the Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er Pro­gram, be­yond an FAQ doc­u­ment post­ed on the agency’s web­site.

FDA Com­mis­sion­er Mar­ty Makary on Fri­day opened up the first pub­lic meet­ing that kicked off ne­go­ti­a­tions for the next gener­ic drug user fee agree­ment be­tween the FDA and in­dus­try, ex­plain­ing the im­por­tance of gener­ic drugs to the US and the need to on­shore more man­u­fac­tur­ing.

The user fee agree­ment, known as GDU­FA IV, will cov­er FY 2028 through 2032 and is like­ly to set cer­tain re­view goal dead­lines for gener­ic drugs in ex­change for user fees set by the leg­is­la­tion. It will al­so set oth­er en­hance­ments so the agency can help the gener­ic drug in­dus­try bring prod­ucts to mar­ket more quick­ly. While the agree­ment has his­tor­i­cal­ly been forged be­tween the FDA and in­dus­try, Con­gress ul­ti­mate­ly has to sign off on the agree­ment be­fore it can be im­ple­ment­ed.

No­var­tis on Fri­day faced a set­back in a key patent case as it fights to keep gener­ic ver­sions of its heart drug En­tresto off the mar­ket.

A fed­er­al dis­trict court in Delaware said No­var­tis failed to prove that MSN Phar­ma­ceu­ti­cals’ gener­ic drug sub­mis­sion in­fringes a patent claim cov­er­ing a com­pound found in No­var­tis’ block­buster heart drug. The case is part of a mul­ti-dis­trict lit­i­ga­tion re­lat­ed to En­tresto patent in­fringe­ment claims.

The phar­ma gi­ant has been in court to try to ex­tend its En­tresto patents and stave off com­pe­ti­tion. The patent at is­sue in this case is set to ex­pire in No­vem­ber 2026.

The rul­ing "re­in­forces MSN’s un­wa­ver­ing fo­cus on re­search ex­cel­lence and our long-stand­ing com­mit­ment to pro­vid­ing high-qual­i­ty, af­ford­able med­i­cines to glob­al mar­kets," MSN Group said in a state­ment to End­points News.

Val­ne­va cleared a key safe­ty hur­dle for its chikun­gun­ya vac­cine af­ter Eu­ro­pean reg­u­la­tors re­moved a tem­po­rary re­stric­tion on its use in old­er adults.

The Eu­ro­pean Med­i­cines Agency an­nounced Fri­day that it had lift­ed the re­stric­tion on adults 65 and old­er, fol­low­ing a re­view of the shot, Ix­chiq. Se­ri­ous ad­verse events had been iden­ti­fied in old­er adults with un­der­ly­ing med­ical con­di­tions, prompt­ing reg­u­la­tors to step in.

The re­view con­clud­ed that “the vac­cine should on­ly be giv­en when there is a sig­nif­i­cant risk of chikun­gun­ya in­fec­tion and af­ter a care­ful con­sid­er­a­tion of the ben­e­fits and risks,” ac­cord­ing to an up­date from EMA.