How to reg­u­late gen­er­a­tive AI was the cen­tral top­ic of the in­au­gur­al two-day meet­ing of the FDA’s new dig­i­tal health ad­vi­so­ry com­mit­tee that be­gan on Wednes­day.

FDA Com­mis­sion­er Rob Califf opened the meet­ing, ex­plain­ing how the agency since 1995 has re­ceived more than 1,000 sub­mis­sions for AI-en­abled med­ical de­vices, more than 300 sub­mis­sions for drugs and bi­o­log­ics with AI com­po­nents, and that al­most every drug ap­pli­ca­tion us­es AI some­where in the de­vel­op­ment process. But he al­so warned that with­out prop­er safe­guards, AI may not make the US health­i­er in the end.

"I'm hear­ing in­creas­ing con­cerns that cri­te­ria for adopt­ing AI are al­most pure­ly fi­nan­cial," Califf said, warn­ing that rur­al Amer­i­ca might be left out. "Clin­i­cal out­come mea­sure­ment is hard. Un­less you take this is­sue very se­ri­ous­ly and form al­liances of those con­cerned about im­prov­ing health out­comes, this tech­nol­o­gy will im­prove prof­its at the cost of de­te­ri­o­ra­tion in our over­all health sta­tus."

Pres­i­dent-elect Don­ald Trump has just set up a show­down for the fu­ture of bio­phar­ma pol­i­cy dur­ing his ad­min­is­tra­tion.

On one side is Trump’s pick to lead the De­part­ment of Health and Hu­man Ser­vices, Robert F. Kennedy Jr. Kennedy is an an­ti-vac­cine ad­vo­cate who, at var­i­ous points, has called for lim­it­ing drug ads, end­ing some gov­ern­ment re­search on phar­ma treat­ments, and a re-re­view of da­ta sup­port­ing vac­cine safe­ty. He has called the re­la­tion­ship be­tween the FDA and in­dus­try cor­rupt, and has said that Amer­i­cans take too many drugs for too lit­tle ben­e­fit.

On the oth­er side is Vivek Ra­maswamy, Trump’s pick to co-lead a new De­part­ment of Gov­ern­ment Ef­fi­cien­cy, charged with cut­ting red tape across gov­ern­ment. Ra­maswamy, a pro-busi­ness lib­er­tar­i­an, is the founder of Roivant Sci­ences, the source of his sig­nif­i­cant wealth.

Eli Lil­ly is now the sec­ond drug­mak­er to pro­pose a re­bate mod­el for 340B drug price dis­counts — and the sec­ond to sue over it.

The com­pa­ny an­nounced Thurs­day that it wants to en­act a “cash re­plen­ish­ment pro­gram” for 340B dis­counts, which were es­tab­lished in 1992 to help hos­pi­tals serv­ing low-in­come pa­tients. Drug­mak­ers par­tic­i­pat­ing in Med­ic­aid are re­quired to pro­vide dis­counts to hos­pi­tals and health cen­ters, known as cov­ered en­ti­ties, in the pro­gram.

Un­der Lil­ly's pro­pos­al, those en­ti­ties would pur­chase 340B drugs at mar­ket price and then re­coup dis­counts lat­er through re­bates. Lil­ly said those changes would “pre­vent abus­es” of the cur­rent 340B pro­gram, in­clud­ing "unchecked du­pli­cate dis­counts."

The FDA on Thurs­day will con­vene an ad­vi­so­ry com­mit­tee to dis­cuss the safe­ty and ef­fi­ca­cy of As­traZeneca’s An­dexxa, which won ac­cel­er­at­ed ap­proval in 2018 to re­verse the an­ti­co­ag­u­la­tion ef­fects of blood thin­ners that can cause life-threat­en­ing bleed­ing.

The Cel­lu­lar, Tis­sue, and Gene Ther­a­pies Ad­vi­so­ry Com­mit­tee will dis­cuss the re­sults of the con­fir­ma­to­ry tri­al for the treat­ment. Al­so known as an­dex­anet, it im­proved up­on the stan­dard of care but al­so re­vealed some safe­ty is­sues and oth­er con­cerns, FDA said in brief­ing doc­u­ments re­leased on Tues­day. The com­mit­tee is­n't sched­uled to vote on a rec­om­men­da­tion.

“Al­though an­dex­anet showed su­pe­ri­or­i­ty of the pri­ma­ry ef­fi­ca­cy end­point over UC with­in the PEP , the su­pe­ri­or ef­fi­ca­cy at 12 hours did not pre­dict longer-term ben­e­fit,” FDA said in its doc­u­ment.

The FDA on Mon­day of­fered new draft guid­ance to help drug­mak­ers un­der­stand the nuts and bolts of FDA process­es for de­vel­op­ing and sub­mit­ting an ap­pli­ca­tion for a new cell or gene ther­a­py, from pre-IND meet­ings to long-term safe­ty mon­i­tor­ing.

The 40-page draft ques­tion-and-an­swer doc­u­ment was cre­at­ed as part of FDA’s com­mit­ment un­der the lat­est user fee deal, and as part of the agen­cy's wider work to in­crease the ef­fi­cien­cy of cell and gene ther­a­py de­vel­op­ment.

"This guid­ance is in­tend­ed to sup­port the de­vel­op­ment of CGT prod­ucts by pro­vid­ing a repos­i­to­ry of com­mon ques­tions posed to the Of­fice of Ther­a­peu­tic Prod­ucts (OTP)," the agency said in the draft.

The FDA hand­ed Chi­nese phar­ma­ceu­ti­cal com­pa­ny Tian­jin Darentang Jing­wan­hong Phar­ma­ceu­ti­cal a warn­ing let­ter af­ter it re­moved in­for­ma­tion from trans­lat­ed man­u­fac­tur­ing records and re­fused to let agency in­spec­tors take pho­tos dur­ing a fa­cil­i&s