The White House threw its weight be­hind ef­forts to help US biotech com­pete with Chi­na, us­ing the ad­min­is­tra­tion's bud­get pro­pos­al to out­line FDA pol­i­cy changes to speed up tri­als, cut costs for com­pa­nies that do ex­per­i­men­tal work in the US, and ex­pe­dite reg­u­la­to­ry re­views.

One of the re­forms is a new clin­i­cal tri­al path­way that re­flects the quick­er process­es oth­er coun­tries have. The ex­pe­dit­ed path­way would be for some Phase 1 tri­als where there are enough ex­ist­ing pre­clin­i­cal da­ta to sat­is­fy reg­u­la­tors. The FDA specif­i­cal­ly ex­pects the path­way to help “small­er biotech­nol­o­gy firms,” say­ing that the US’ ex­ist­ing IND process has fu­eled growth in Chi­na and Aus­tralia.

“The goal of this new path­way is to ac­cel­er­ate the drug de­vel­op­ment time­line and en­cour­age US biotech­nol­o­gy in­vest­ment — in line with the Pres­i­dent’s ac­tions to on­shore the phar­ma­ceu­ti­cal in­dus­try,” ac­cord­ing to the bud­get re­quest.

Steve Ubl, the head of the drug in­dus­try's pow­er­ful Wash­ing­ton, DC, lob­by­ing group PhRMA, plans to step down, End­points News has learned from sources fa­mil­iar with his plans.

Ubl's de­ci­sion comes ahead of a piv­otal US elec­tion this year that will de­cide con­trol of Con­gress. His con­tract runs through the end of the year, ac­cord­ing to two sources.

A rep­re­sen­ta­tive for PhRMA did­n't im­me­di­ate­ly re­spond to a re­quest for com­ment.

Max Bay­er con­tributed re­port­ing. This is a de­vel­op­ing sto­ry and will be up­dat­ed...

Pres­i­dent Don­ald Trump has signed an ex­ec­u­tive or­der con­firm­ing that drug prod­ucts that come from a sub­set of coun­tries and man­u­fac­tur­ers will face 100% tar­iffs with­in the next sev­er­al months.

Un­der the White House­'s tar­iff plan, man­u­fac­tur­ers with a "most fa­vored na­tion" (MFN) pric­ing deal and that are on­shoring ca­pac­i­ty to the US won't face the tar­iffs. Al­so ex­empt will be drugs from places that have struck deals with the US, in­clud­ing the UK, EU and South Ko­rea, ac­cord­ing to Thurs­day's an­nounce­ment.

The levies are be­ing is­sued un­der Sec­tion 232 of the Trade Ex­pan­sion Act, fol­low­ing an in­ves­ti­ga­tion by the De­part­ment of Com­merce that start­ed in April 2025. But the many ex­emp­tions in the or­der mean that on­ly a lim­it­ed set of prod­ucts will like­ly face tar­iffs in the end.

The FDA plans to re­duce the amount of da­ta re­quired to start a new drug tri­al in the US, cut­ting out most parts that aren’t safe­ty-re­lat­ed, FDA Com­mis­sion­er Mar­ty Makary told re­porters on Wednes­day.

The goal is to sim­pli­fy and ex­pe­dite the process of ap­ply­ing for an in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion, said Makary, who is en­ter­ing his sec­ond year lead­ing the FDA un­der the Trump ad­min­is­tra­tion. It’s a goal sup­port­ed by drug de­vel­op­ers, who have framed these re­forms as es­sen­tial to com­pet­ing against Chi­na's speedy clin­i­cal tri­al process.

“We are go­ing to re­duce the re­quire­ments of the IND ap­pli­ca­tion, re­mov­ing parts of the ap­pli­ca­tion that are not im­por­tant for safe­ty,” Makary said on the call. Ca­reer sci­en­tists at the agency will de­cide what parts aren’t nec­es­sary or could be re­viewed lat­er in the ap­proval process, he said.

The White House this week be­gan of­fer­ing a $950-per-month ver­sion of Ab­b­Vie's megablock­buster Hu­mi­ra on TrumpRx, even as the drug dis­count web­site al­so of­fers two Hu­mi­ra biosim­i­lars from Pfiz­er and Am­gen that both cost less than $300 per month.

It re­mains un­clear who would pur­chase brand-name Hu­mi­ra through TrumpRx. The cash-pay gov­ern­ment web­site does­n't ac­cept in­sur­ance, and those on Hu­mi­ra with cov­er­age can pay as lit­tle as $5. Those on Medicare have seen their out-of-pock­et ex­pens­es capped at $2,000 per year. Its in­clu­sion was part of Ab­b­Vie's "most fa­vored na­tion" deal with the White House in Jan­u­ary.

Now Eli Lil­ly has an obe­si­ty pill, too.

On Wednes­day, the FDA ap­proved or­for­glipron, the agency an­nounced. It will be sold as Foun­dayo, and Lil­ly has pre­vi­ous­ly said it plans to sell a start­ing dose for $149 a month and high­er dos­es for up to $349 a month.

The ini­tial price ris­es to $349 for sub­se­quent dos­es if the pa­tient does not re­fill with­in a 45-day win­dow, a Lil­ly spokesper­son con­firmed to End­points News. If they do re­fill with­in that time, it would be a max­i­mum of $299 per month through the Foun­dayo self-pay pro­gram.