The Cen­ters for Medicare and Med­ic­aid Ser­vices has nev­er played a sig­nif­i­cant role in reg­u­lat­ing phar­ma­cy ben­e­fit man­agers, the mid­dle­men that have his­tor­i­cal­ly re­lied on high drug prices for prof­its. But the gov­ern­ment spend­ing pack­age that's near­ing the fin­ish line this week is poised to change that.

The sweep­ing, bi­par­ti­san re­forms would be­gin to take ef­fect in 2028 and are seen by many as a win for the phar­ma in­dus­try. The changes, which have been float­ed in var­i­ous forms in Con­gress for at least three years, will re­de­fine how PBMs can be com­pen­sat­ed and make CMS the new stan­dard-set­ter for how they op­er­ate.

The Sen­ate passed the spend­ing bill last week, and the House nar­row­ly passed the bill on Tues­day, paving the way for Pres­i­dent Don­ald Trump's sig­na­ture.

Pres­i­dent Don­ald Trump on Tues­day signed the gov­ern­ment fund­ing ex­ten­sion that al­so reau­tho­rized the FDA's abil­i­ty to is­sue rare pe­di­atric pri­or­i­ty re­views through 2029, re­viv­ing an in­cen­tive pro­gram that in­dus­try has fought to keep.

The pro­gram ex­pired in late 2024 af­ter pro­vid­ing trans­fer­able vouch­ers for a dozen years to com­pa­nies that won ap­proval for drugs to treat rare pe­di­atric ill­ness­es, in­clud­ing cer­tain can­cers and ge­net­ic dis­eases. The vouch­ers can be used to speed ap­proval of a fu­ture drug, and can al­so be sold. In re­cent years, they’ve of­ten gone for more than $100 mil­lion each.

The reau­tho­riza­tion has lin­gered for more than a year, but the FDA has con­tin­ued to award PRVs that had al­ready re­ceived rare pe­di­atric des­ig­na­tions pri­or to the pro­gram's sun­set­ting in De­cem­ber 2024. The FDA is­sued at least three PRVs last year.

The White House is punt­ing the launch of TrumpRx, the ad­min­is­tra­tion’s hub for di­rect-to-con­sumer web­sites run by large drug­mak­ers.

The event was ex­pect­ed to take place Fri­day, but it’s been post­poned, two sources fa­mil­iar with the sit­u­a­tion told End­points News. It’s un­clear why the event is be­ing moved, af­ter ad­min­is­tra­tion of­fi­cials had teased on mul­ti­ple oc­ca­sions that the web­site would launch be­fore the end of the month. It's al­so not clear when the event will be resched­uled.

The White House did not im­me­di­ate­ly re­spond to a re­quest for com­ment. HHS Sec­re­tary Robert F. Kennedy Jr. said at a Cab­i­net meet­ing Thurs­day that TrumpRx would be re­leased "some­time prob­a­bly in the next 10 days."

Sev­er­al years of ques­tions about Am­gen's rare dis­ease treat­ment Tavneos have reached a cli­max af­ter the FDA asked the com­pa­ny to pull the drug from the mar­ket, and Am­gen said it has no plans to do so.

Am­gen said the reg­u­la­tor asked for the vol­un­tary with­draw­al of Tavneos on Jan. 16. The drug was first ap­proved by the FDA in 2021, and Am­gen ac­quired it the next year as part of its $4 bil­lion ac­qui­si­tion of Chemo­Cen­tryx.

It's al­so un­der a sim­i­lar re­view by Eu­ro­pean reg­u­la­tors, who said Fri­day they were look­ing at da­ta in­tegri­ty ques­tions from the piv­otal tri­al used for ap­proval.

An FDA re­jec­tion let­ter for Cor­cept Ther­a­peu­tics’ po­ten­tial hor­mon­al dis­or­der drug says the agency told the com­pa­ny it had se­ri­ous con­cerns be­fore the ap­pli­ca­tion was sub­mit­ted.

The com­plete re­sponse let­ter, re­leased Fri­day, again shows how some com­pa­nies have not ful­ly ex­plained the rea­sons be­hind a re­jec­tion de­ci­sion in their pub­lic an­nounce­ments. This is the first CRL the FDA has re­leased in 2026, fol­low­ing the agen­cy's first-ever re­lease of more than 200 re­jec­tion let­ters last year.

On Dec. 31, 2025, Cor­cept an­nounced the FDA's re­jec­tion of rela­co­ri­lant as a drug for hy­per­ten­sion sec­ondary to Cush­ing's syn­drome in a re­lease, not­ing the FDA "could not ar­rive at a fa­vor­able ben­e­fit-risk as­sess­ment for rela­co­ri­lant." At the time, the CEO said the com­pa­ny was "sur­prised" by the re­jec­tion.