The process by which in­sti­tu­tion­al re­view boards over­see clin­i­cal tri­als needs re­forms that are "big and dif­fer­ent" so that the US can keep pace with Chi­na, FDA Com­mis­sion­er Mar­ty Makary said.

The FDA has to look "at the en­tire process" and short­en the time frame for clin­i­cal tri­al spon­sors from Phase 1 meet­ing re­quests to in­ves­ti­ga­tion­al new drug ap­pli­ca­tions, Makary told at­ten­dees Mon­day at the 2026 CMS Qual­i­ty Con­fer­ence in Bal­ti­more.

"Chi­na is ini­ti­at­ing four times the clin­i­cal Phase 1 tri­als as the Unit­ed States," Makary said, speak­ing along­side CMS Ad­min­is­tra­tor Mehmet Oz and NIH Di­rec­tor Jay Bhat­tacharya. The pre-IND phase runs about 380 days in the US, Makary said, while Chi­na is about 220 days and "they just an­nounced they're go­ing to go to 60."

The FDA un­veiled long-await­ed draft guid­ance on how bio­phar­ma com­pa­nies can val­i­date new ap­proach­es for tox­i­col­o­gy and oth­er ear­ly-phase safe­ty stud­ies, po­ten­tial­ly re­duc­ing the an­i­mal test­ing that's long been used to as­sess the risks of ex­per­i­men­tal drugs for hu­mans.

In some cir­cum­stances, the new tools could "re­place an­i­mal test­ing while ad­vanc­ing pre­dic­tive tox­i­col­o­gy us­ing hu­man-cen­tric meth­ods," ac­cord­ing to the eight-page doc­u­ment re­leased Wednes­day.

The guid­ance stems from leg­is­la­tion passed in 2022, clar­i­fy­ing that non-an­i­mal al­ter­na­tives can be used to sup­port in­ves­ti­ga­tion­al new drug ap­pli­ca­tions or biosim­i­lar bi­o­log­ics li­cense ap­pli­ca­tions in lieu of an­i­mal stud­ies. The draft out­lines four prin­ci­ples that would be used to val­i­date pro­posed non-an­i­mal stud­ies: a mod­el's con­text of use, bi­o­log­i­cal rel­e­vance, tech­ni­cal char­ac­ter­i­za­tion and whether it's fit to as­sist CDER in its de­ci­sion-mak­ing.

A fed­er­al judge has paused the Trump ad­min­is­tra­tion’s over­haul of the child­hood vac­cine sched­ule in a court or­der that deals a set­back to HHS Sec­re­tary Robert F. Kennedy Jr.’s pol­i­cy agen­da.

US Dis­trict Judge Bri­an Mur­phy said Mon­day that the plain­tiffs are “like­ly to suc­ceed” in show­ing that a Jan­u­ary de­ci­sion to down­grade rec­om­men­da­tions for six vac­cines on the sched­ule vi­o­lates the Ad­min­is­tra­tive Pro­ce­dure Act.

Mur­phy al­so sus­pend­ed the ap­point­ments of 13 mem­bers on the CDC’s re­con­sti­tut­ed vac­cine ad­vi­so­ry pan­el, and stayed the votes tak­en by those mem­bers. That pan­el was sched­uled to meet start­ing on Wednes­day, but an HHS of­fi­cial said the meet­ing is post­poned.

“HHS looks for­ward to this judge’s de­ci­sion be­ing over­turned just like his oth­er at­tempts to keep the Trump ad­min­is­tra­tion from gov­ern­ing,” HHS spokesper­son An­drew Nixon told End­points News.

The bio­phar­ma in­dus­try is look­ing for cre­ative ways to cush­ion the ef­fect of the Trump ad­min­is­tra­tion’s “most fa­vored na­tion” deals on US pric­ing.

Two lawyers who work with bio­phar­ma com­pa­nies told End­points News that they’ve had an uptick in in­quiries on whether amend­ing li­cens­ing con­tracts could be a way to do so.

A typ­i­cal type of li­cens­ing agree­ment is when a drug de­vel­op­er li­cens­es an as­set to a large com­mer­cial part­ner in ter­ri­to­ries where the de­vel­op­er can't ex­e­cute the launch it­self, said Adam Gold­en, an M&A and IP trans­ac­tions lawyer at Fresh­fields. The phar­ma part­ner would roll out the prod­uct and pay roy­al­ties, which can be a per­cent­age of the drug’s sales, and mile­stone pay­ments back to the biotech.

To help with new pi­lot mod­els aimed at low­er­ing drug costs across Med­ic­aid and Medicare, CM­S' in­no­va­tion cen­ter is ramp­ing up staff.

"We are on track to more than dou­ble the size of our team that works on drugs, and we still have open­ings," Abe Sut­ton, di­rec­tor of the Cen­ter for Medicare and Med­ic­aid In­no­va­tion (CM­MI), said Tues­day at the 2026 CMS Qual­i­ty Con­fer­ence in Bal­ti­more. "We're putting thought in­to ar­eas where there's been bar­ri­ers that have slowed down up­take and ac­cess for pa­tients."

Since last No­vem­ber, CM­MI has un­veiled four dif­fer­ent drug pric­ing mod­els as part of the Trump ad­min­is­tra­tion's "most fa­vored na­tion" push to low­er the cost of med­i­cines. It launched one fo­cused on MFN pric­ing un­der Med­ic­aid, and an­oth­er to broad­en cov­er­age of GLP-1 weight loss drugs. The cen­ter al­so pro­posed two MFN-based pric­ing mod­els for Medicare Parts B and D — known as GLOBE and GUARD.