On Thurs­day, the FDA fi­nal­ly did what sev­er­al pri­or agency com­mis­sion­ers on­ly promised to do: pub­lish redact­ed com­plete re­sponse let­ters for drugs that are still un­der con­sid­er­a­tion by the agency de­spite the ini­tial re­jec­tion.

The 89 let­ters in­clude some re­cent high-pro­file — and some­times con­tentious — re­jec­tions of drugs from Replimune, Capri­cor Ther­a­peu­tics, Stealth Bio­Ther­a­peu­tics and many oth­ers. And while the let­ters will add in­sight in­to why the FDA turned down the drugs, the ac­tion is al­most cer­tain to be con­tro­ver­sial, or chal­lenged legal­ly, if some com­pa­nies ob­ject to the re­lease of what has long been thought of as pro­pri­etary and con­fi­den­tial in­for­ma­tion.

"This def­i­nite­ly seems like a his­toric first in en­sur­ing trans­paren­cy," Resh­ma Ra­machan­dran, a Yale physi­cian and chair of the Doc­tors for Amer­i­ca FDA Task Force, told End­points News. "It’ll be in­ter­est­ing to see if mov­ing for­ward, FDA will pro­vide ac­tu­al re­al-time ac­cess to these let­ters."

HHS on Tues­day un­veiled its long-await­ed Make Amer­i­ca Healthy Again strat­e­gy re­port, in­clud­ing plans for changes to the child­hood vac­cine sched­ule, stricter over­sight of how drugs are ad­ver­tised to pa­tients, and ap­proach­es that could speed some new drug de­vel­op­ment.

The new re­port, which builds off of an ear­li­er one from May, is still light on de­tails about vac­cine-re­lat­ed changes. It says the White House Do­mes­tic Pol­i­cy Coun­cil and HHS will de­vel­op a new vac­cine frame­work to en­sure the US "has the best child­hood vac­cine sched­ule" and will be "mod­ern­iz­ing Amer­i­can vac­cines with trans­par­ent, gold-stan­dard sci­ence" while "en­sur­ing sci­en­tif­ic and med­ical free­dom."

It al­so em­braces the skep­ti­cism that HHS Sec­re­tary Robert F. Kennedy Jr. has for many vac­cines, which HHS and oth­er health agen­cies have trans­formed in­to ac­tion through pol­i­cy changes and re­plac­ing many gov­ern­ment lead­ers, ad­vi­sors and ex­perts.

The suc­cess sto­ry of ba­by KJ’s cus­tomized CRISPR ther­a­py and the prospects for oth­ers like it have the FDA ready­ing a new ap­proval path­way for those with ex­treme­ly lim­it­ed treat­ment op­tions.

The new path­way will be for nov­el ther­a­pies in­tend­ed for just one or a few pa­tients, the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search Di­rec­tor Vinay Prasad told a Duke-Mar­go­lis work­shop last week. The agency is plan­ning to out­line it in the New Eng­land Jour­nal of Med­i­cine, ac­cord­ing to Prasad, who de­scribed it as "the plau­si­ble mech­a­nism path­way."

The idea was first float­ed by FDA Com­mis­sion­er Mar­ty Makary in April, who de­scribed it at the time as a "con­di­tion­al ap­proval" path­way. Prasad said that “it will be a nov­el path­way for drug de­vel­op­ers who are pur­su­ing be­spoke ther­a­py. By that, I mean com­plete­ly in­di­vid­u­al­ized ther­a­py that ba­by A gets one treat­ment, B gets the next treat­ment, ba­by C gets a dif­fer­ent treat­ment.”

Pres­i­dent Don­ald Trump is look­ing to strike more deals with trade part­ners and says he “may be will­ing” to ex­empt some phar­ma­ceu­ti­cal prod­ucts from fu­ture tar­iffs.

An ex­ec­u­tive or­der re­leased last week es­tab­lish­es a new list of prod­ucts, dubbed An­nex III, that could face a 0% rec­i­p­ro­cal tar­iff rate de­pend­ing on the deal. Items list­ed un­der An­nex III in­clude an ar­ray of phar­ma­ceu­ti­cal prod­ucts such as cell ther­a­pies, cer­tain vac­cines, an­tibi­otics and oth­er chem­i­cals and hor­mones.

The Fri­day or­der de­fined the phar­ma prod­ucts list­ed un­der An­nex III as “non-patent­ed ar­ti­cles for use in phar­ma­ceu­ti­cal ap­pli­ca­tions.”

Yet no fur­ther de­tails were giv­en, sug­gest­ing that brand­ed drugs with ex­pired patents could be ex­empt­ed from tar­iffs if they fall un­der the An­nex III list. Al­ter­na­tive­ly, the ad­min­is­tra­tion could sim­ply be defin­ing gener­ic phar­ma­ceu­ti­cals as “non-patent­ed” drugs, Mol­lie Sitkows­ki, a trade com­pli­ance part­ner at US law firm Fae­gre Drinker, told End­points News. 

BETHES­DA, MD — FDA Com­mis­sion­er Mar­ty Makary said the agency will soon be­gin in­spect­ing more for­eign drug man­u­fac­tur­ers with­out ad­vance no­tice, a move that's been in the works for years and would align its over­sight of do­mes­tic and over­seas fa­cil­i­ties.

The FDA is in the process of chang­ing to more "sur­prise in­spec­tions and hav­ing a ba­sic safe­ty in­spec­tion list so we're not putting com­pa­nies through the ringer in the Unit­ed States and then let­ting com­pa­nies over­seas have a much lighter in­spec­tion load," Makary said Thurs­day at the Mary­land Tech­nol­o­gy Coun­cil's Bio In­no­va­tion Con­fer­ence.

The agency said in May that it was plan­ning on do­ing more sur­prise in­spec­tions of for­eign fac­to­ries.