An an­nu­al re­port to Con­gress on Chi­na’s glob­al reach says the US is over­re­liant on Chi­na’s pro­duc­tion of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, pos­ing a na­tion­al se­cu­ri­ty con­cern to the phar­ma sup­ply chain.

The US-Chi­na Eco­nom­ic and Se­cu­ri­ty Re­view Com­mis­sion’s re­port rec­om­mends that Con­gress “build U.S. phar­ma­ceu­ti­cal sup­ply chain re­silience.” The vast ma­jor­i­ty of all drugs used in the US are gener­ics, but near­ly a quar­ter of their in­gre­di­ents are “po­ten­tial­ly” sourced from Chi­na, the re­port found.

The prob­lem is worse for oral gener­ic pills. The US man­u­fac­tures less than a quar­ter of its oral gener­ics and in­stead re­lies heav­i­ly on In­dia and Chi­na.

"The Unit­ed States cur­rent­ly faces a fu­ture in which it de­pends on Chi­na for ac­cess to the most cut­ting-edge biotech­nol­o­gy in­no­va­tions, so­phis­ti­cat­ed bio­man­u­fac­tur­ing equip­ment, and ad­vanced bio­ma­te­ri­als," a sum­ma­ry of the re­port says.

FDA Com­mis­sion­er Mar­ty Makary is em­brac­ing the Trump ad­min­is­tra­tion's "Amer­i­ca First" mantra, seek­ing po­ten­tial­ly high­er user fees for com­pa­nies op­er­at­ing out­side the US.

"If your Phase 1 tri­al is not in the Unit­ed States, maybe you should pay a high­er user fee," Makary said at a sup­ply chain re­silien­cy meet­ing at the Na­tion­al Acad­e­mies of Sci­ences, En­gi­neer­ing, and Med­i­cine late last month.  The FDA and in­dus­try are about to kick off ne­go­ti­a­tions for the next round of user fees un­der PDU­FA VI­II, which will run from 2028 through 2032.

Asked whether the FDA will call for high­er ex-US user fees in the ne­go­ti­a­tions over the next year, an FDA spokesper­son told End­points News on Tues­day that the ad­min­is­tra­tion "is pri­or­i­tiz­ing an Amer­i­ca first ap­proach to all ac­tiv­i­ties, in­clud­ing drug de­vel­op­ment and re­search. FDA is con­sid­er­ing a wide range of op­tions to sup­port Amer­i­can in­no­va­tion and en­sure the in­tegri­ty and ac­cu­ra­cy of clin­i­cal tri­als for prod­ucts that Amer­i­cans de­pend on."

The FDA has ap­proved Ar­row­head Phar­ma­ceu­ti­cals’ Re­dem­p­lo for a rare dis­ease in which pa­tients can't break down cer­tain fat mol­e­cules, set­ting up a ri­val­ry be­tween the com­pa­ny and Io­n­is.

The new en­trant will have to take on an es­tab­lished prod­uct in a tiny mar­ket — no easy task.

Io­n­is’ Tryn­golza be­came the first treat­ment for fa­mil­ial chy­lomi­crone­mia syn­drome (FCS) near­ly a year ago. There are on­ly a few thou­sand FCS pa­tients in the US and EU com­bined, so Tryn­golza was able to se­cure rare dis­ease pric­ing. Its list price is just un­der $600,000 per year.

Ar­row­head said Re­dem­p­lo is now the com­pa­ny's first FDA-ap­proved med­i­cine and lever­ages its pro­pri­etary Tar­get­ed RNAi Mol­e­cule plat­form. It said it will be avail­able in the US be­fore the end of the year. A spokesper­son for Ar­row­head said the an­nu­al list price will be $60,000.

In a let­ter on Tues­day to Eli Lil­ly CEO David Ricks, Sen. Ruben Gal­lego (D-AZ) said the com­pa­ny needs to ex­plain the de­tails of its deal with the Trump ad­min­is­tra­tion over its weight loss drugs, an ear­ly hint of the type of over­sight that drug­mak­ers and the ad­min­is­tra­tion might face if Re­pub­li­cans lose con­trol of the House or Sen­ate next year.

Gal­lego wrote that "the pub­lic has been pro­vid­ed with on­ly sparse de­tails" about the deal. Those in­clude how it will work with the ad­min­is­tra­tion's in­com­ing on­line phar­ma­cy TrumpRx, its in­ter­ac­tion with price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act, and how it al­lows Lil­ly to avoid tar­iffs.

"It is al­so un­clear how this deal in­ter­acts with ex­ist­ing fed­er­al law, and the TrumpRx plat­form’s re­quire­ment that pa­tients for­go in­sur­ance cov­er­age and pay out-of-pock­et," Gal­lego wrote.