The FDA's ex­ter­nal re­search con­duct­ed by uni­ver­si­ties, typ­i­cal­ly on com­plex pub­lic health chal­lenges, will see a re­design in the next year, HHS con­firmed to End­points News.

The pro­gram, known as the Cen­ters of Ex­cel­lence in Reg­u­la­to­ry Sci­ence and In­no­va­tion (CER­SI), brings in top uni­ver­si­ties that con­duct re­search for FDA cen­ters. For ex­am­ple, Yale has per­formed re­search on in­flu­enc­ing pre­scriber de­ci­sion-mak­ing on opi­oids for the FDA's drug cen­ter, and the Uni­ver­si­ty of Cal­i­for­nia at San Fran­cis­co (UCSF) has stud­ied off-tar­get sites for genome-edit­ed prod­ucts.

Un­der the pro­gram, the FDA part­ners with re­searchers, who each re­ceive up to $50 mil­lion over five years. Cur­rent CER­SI pro­grams in­clude Johns Hop­kins, the Uni­ver­si­ty of Mary­land, Yale and the Mayo Clin­ic, UCSF and Stan­ford, and one in Re­search Tri­an­gle Park in North Car­oli­na.

Pe­ter Marks, the for­mer FDA of­fi­cial, is join­ing Eli Lil­ly as a se­nior vice pres­i­dent for mol­e­cule dis­cov­ery and the head of in­fec­tious dis­eases.

Marks and a spokesper­son for Lil­ly con­firmed his ap­point­ment to End­points News.

"Pe­ter's ex­per­tise strength­ens our abil­i­ties across mul­ti­ple ar­eas, both in our ex­ist­ing port­fo­lio and in our work in emerg­ing ar­eas," a com­pa­ny spokesper­son said in a state­ment to End­points.

Bio­Cen­tu­ry first re­port­ed his ap­point­ment.

Marks, who led the FDA's Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search for near­ly a decade, was one of the reg­u­la­tor's most high-pro­file de­par­tures when he re­signed in March in protest of HHS Sec­re­tary Robert F. Kennedy Jr.’s stance on vac­cine safe­ty. As head of CBER, Marks over­saw the reg­u­la­tion of vac­cines and cell and gene ther­a­pies.

The fed­er­al gov­ern­men­t's on­go­ing shut­down means that the FDA can't ac­cept new drug or bi­o­log­ic sub­mis­sions that re­quire a user fee. But it may not change this year's pace of ap­pli­ca­tions — yet.

While De­moc­rats and Re­pub­li­cans have yet to work out a deal for fund­ing the gov­ern­ment, com­pa­nies in­clud­ing Mod­er­na, Virid­i­an Ther­a­peu­tics, Co­gent Bio­sciences and Avid­i­ty Bio­sciences told End­points News that the shut­down is­n't ex­pect­ed to af­fect their up­com­ing fil­ings, all of which are planned be­fore the end of the year.

A Co­gent spokesper­son told End­points that its ap­pli­ca­tion for its lead can­di­date, the ty­ro­sine ki­nase in­hibitor bezu­clas­tinib, is still planned for some­time this year. Avid­i­ty said it's al­so still prepar­ing its sub­mis­sion for its Duchenne mus­cu­lar dy­s­tro­phy treat­ment del­pacibart zo­tadirsen by year's end, and "will com­mu­ni­cate if some­thing changes."

A non­prof­it with a his­to­ry of beat­ing the FDA in court on First Amend­ment grounds sent a stern let­ter to Com­mis­sion­er Mar­ty Makary this week over the agen­cy's re­cent crack­down on di­rect-to-con­sumer phar­ma ads.

The Wash­ing­ton Le­gal Foun­da­tion told Makary the agen­cy's "flur­ry of en­force­ment let­ters" last month "threat­ens to chill" com­pa­nies' pro­tect­ed speech. The FDA had said it was send­ing about 100 cease-and-de­sist let­ters and thou­sands of warn­ing let­ters to phar­ma com­pa­nies over al­leged­ly false or mis­lead­ing ads.

But "by tar­get­ing man­u­fac­tur­ers’ truth­ful, non-mis­lead­ing speech un­der the guise of pre­vent­ing de­cep­tion, FDA’s self-de­scribed 'crack­down' threat­ens to erode core First Amend­ment pro­tec­tions," WLF said in the let­ter dat­ed Mon­day. "If chal­lenged, many of these mea­sures would like­ly fail con­sti­tu­tion­al scruti­ny."

The FDA has re­vealed a new pi­lot pro­gram, dubbed the ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA), which will en­cour­age drug­mak­ers to use do­mes­tic sup­plies of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for gener­ic drugs.

The new pro­gram will speed up the re­view process for gener­ic drugs for drug­mak­ers who man­u­fac­ture prod­ucts in the US, ac­cord­ing to the FDA's Fri­day press re­lease. Gener­ic drugs make up about 92% of US re­tail and mail phar­ma­cy pre­scrip­tions, ac­cord­ing to a Brook­ings In­sti­tute re­port from March.

Com­pa­nies will be el­i­gi­ble for the pi­lot pro­gram if they are ex­clu­sive­ly us­ing US-based API sources, and if they con­duct any bioe­quiv­a­lence test­ing in the US.

“Over-re­liance on for­eign drug man­u­fac­tur­ing and test­ing cre­ates risks both to na­tion­al se­cu­ri­ty and pa­tient ac­cess, and un­der­mines in­vest­ments in US re­search, man­u­fac­tur­ing and pro­duc­tion,” CDER di­rec­tor George Tid­marsh said in the an­nounce­ment.