The FDA on Tues­day re­leased 40 let­ters sent to com­pa­nies as part of its crack­down on phar­ma­ceu­ti­cal ads, re­veal­ing some of its crit­i­cisms on how risks and ben­e­fits of drugs are pre­sent­ed.

The un­ti­tled let­ters con­cen­trat­ed most­ly on tele­vi­sion ads from Pfiz­er, No­var­tis, Bris­tol My­ers Squibb, Ab­b­Vie, Al­ny­lam, Boehringer In­gel­heim, Sanofi, As­traZeneca and oth­ers. Sev­er­al com­pa­nies re­ceived mul­ti­ple let­ters each.

Bris­tol My­ers, for ex­am­ple, re­ceived three un­ti­tled let­ters for "false or mis­lead­ing" TV ads re­lat­ed to their block­buster can­cer drug Op­di­vo and their car­diomy­opa­thy drug Camzyos. In the let­ter, the agency took is­sue with the safe­ty ex­pla­na­tions in each, among oth­er con­cerns.

All el­i­gi­ble drug­mak­ers have ap­plied to par­tic­i­pate in the gov­ern­ment’s pi­lot pro­gram test­ing a re­bate mod­el for cer­tain 340B drug dis­counts, an HHS spokesper­son said.

No­var­tis and Bris­tol My­ers Squibb con­firmed to End­points News that they sub­mit­ted their plans for the pro­gram to the Health Re­sources and Ser­vices Ad­min­is­tra­tion, fol­low­ing a Mon­day dead­line to do so. John­son & John­son and As­traZeneca al­so told End­points they in­tend to par­tic­i­pate in the pi­lot.

The pi­lot could change how the fed­er­al drug dis­count pro­gram has op­er­at­ed for decades. A re­bate mod­el would re­quire health cen­ters to pur­chase cer­tain 340B-el­i­gi­ble drugs at mar­ket price and then re­coup the dis­counts via re­bates, as op­posed to up­front. Sev­er­al phar­ma com­pa­nies have been fight­ing HRSA in court over pro­pos­als to im­ple­ment their own re­bate mod­els to ad­dress what they claim is fraud and abuse of the pro­gram. Some com­pa­nies have ar­gued that such a mod­el would help pre­vent du­pli­cate dis­counts on drugs ne­go­ti­at­ed un­der the In­fla­tion Re­duc­tion Act.

The re­new­al of the FDA’s over-the-counter (OTC) drug user fee pro­gram was tucked in­to a stop­gap spend­ing pack­age to fund the gov­ern­ment through Nov. 21, ac­cord­ing to a draft post­ed by the House Ap­pro­pri­a­tions Com­mit­tee on Tues­day.

The leg­is­la­tion, which is mak­ing its way through the House Rules Com­mit­tee, spec­i­fies how to set the user fee lev­els for the pro­gram, known as OM­U­FA. Sim­i­lar to the FDA's drug and de­vice user fee pro­grams, OM­U­FA re­quires in­dus­try to pay fees to help sup­port FDA’s work on OTC drugs. In ex­change, the agency agrees to ad­here to per­for­mance goals on tim­ing.

OTC drug man­u­fac­tur­ers cur­rent­ly pay about $37,000 an­nu­al­ly to reg­is­ter man­u­fac­tur­ing and pro­cess­ing fa­cil­i­ties, as well as oth­er fees that have steadi­ly in­creased over the years. OM­U­FA is set to ex­pire on Sept. 30.

CSL and Var­mX have inked a $117 mil­lion deal fo­cused on ad­vanc­ing the Dutch biotech’s blood co­ag­u­la­tion can­di­date’s Phase 3 de­vel­op­ment. And if that tri­al yields pos­i­tive re­sults, the Aus­tralian drug­mak­er could end up buy­ing the com­pa­ny al­to­geth­er.

CSL will fund an on­go­ing Phase 3 tri­al of Var­mX’s re­com­bi­nant Fac­tor X pro­tein called VMX-C001. It will sup­port “late-stage prod­uct de­vel­op­ment, man­u­fac­tur­ing and pre-launch com­mer­cial and med­ical af­fairs ac­tiv­i­ties” for the pro­gram, ac­cord­ing to a Tues­day re­lease.

If CSL ex­er­cis­es its ex­clu­sive op­tion to ac­quire Var­mX, the biotech could get up to $388 mil­lion ahead of the launch of the drug, which is an­tic­i­pat­ed in 2029. Var­mX would al­so be el­i­gi­ble for up to $1.7 bil­lion in sales mile­stones.