The FDA plans to con­sol­i­date some ad­min­is­tra­tive func­tions, but won't em­bark on a whole­sale re­or­ga­ni­za­tion of the re­view cen­ters that over­see drugs, bi­o­log­ics and med­ical de­vices, FDA Com­mis­sion­er Mar­ty Makary said in an in­ter­view pub­lished Tues­day.

"Yes, we are con­sol­i­dat­ing trav­el of­fices, IT, and some oth­er things that make sense for ef­fi­cien­cy, but noth­ing else is planned," Makary told Har­vard physi­cian Je­re­my Faust in an in­ter­view.

The agency and HHS had pre­vi­ous­ly con­sid­ered the idea of re­or­ga­niz­ing the agency in­to five shared ser­vices of­fices. The pro­pos­al, first re­port­ed by End­points News, fol­lowed sweep­ing job cuts tar­get­ing about 3,500 FDA em­ploy­ees. The Trump ad­min­is­tra­tion, in many cas­es led by Elon Musk's DOGE ini­tia­tive, has tar­get­ed sim­i­lar cuts across the gov­ern­ment.

The fate of a small, pri­vate­ly-held biotech’s new drug has been de­layed, in what ap­pears to be a sign that broad cuts to the FDA by the Trump ad­min­is­tra­tion may be af­fect­ing key reg­u­la­to­ry de­ci­sions.

Stealth Bio­Ther­a­peu­tics said the FDA would not meet its Tues­day dead­line for ap­prov­ing or re­ject­ing the com­pa­ny’s drug, elamipre­tide. It had been seek­ing reg­u­la­to­ry clear­ance of elamipre­tide for a rare dis­ease called Barth syn­drome, which af­fects on­ly about 150 peo­ple in the US and caus­es heart ab­nor­mal­i­ties and mus­cle weak­ness. About 85% of pa­tients don't make it past the age of 5.

In a state­ment Tues­day, Stealth said that “the U.S. Food and Drug Ad­min­is­tra­tion (FDA) com­mu­ni­cat­ed that it would not meet to­day’s pre­scrip­tion drug user fee ac­tion (PDU­FA) date for its new drug ap­pli­ca­tion.”

No­vavax said it's re­spond­ed to the FDA's re­quest for a new clin­i­cal tri­al post-ap­proval of the com­pa­ny's Covid-19 vac­cine, fol­low­ing a re­port that the agency asked for a ran­dom­ized study that could cost No­vavax mil­lions of dol­lars.

The up­date Mon­day fol­lowed re­port­ing from the Wall Street Jour­nal late last week that the FDA had re­quest­ed the new ran­dom­ized study. No­vavax ini­tial­ly dis­closed that the agency had asked for a post-mar­ket­ing com­mit­ment to pro­duce ad­di­tion­al da­ta, but didn’t spec­i­fy what kind of da­ta it was be­ing asked for. The com­pa­ny wouldn’t con­firm the specifics of the re­quest fol­low­ing the Jour­nal's re­port.

CHARLESTON, SC — HHS Sec­re­tary Robert F. Kennedy Jr. said Fri­day that 35 states had signed up to par­tic­i­pate in a new pay­ment mod­el meant to im­prove ac­cess to and low­er costs for gene ther­a­pies for sick­le cell dis­ease.

The lev­el of par­tic­i­pa­tion in the vol­un­tary mod­el is “un­prece­dent­ed” and rep­re­sents a “re­al win-win” for states and pa­tients with Med­ic­aid, Kennedy said dur­ing a short speech at the Na­tion­al Coun­cil of In­sur­ance Leg­is­la­tors’ spring meet­ing in Charleston, SC.

The pro­gram "il­lus­trates a broad­er prin­ci­ple that I want to re­al­ize through­out HHS. Peo­ple as­sume that bud­get cuts trans­late in­to worse ser­vice for ben­e­fi­cia­ries, and I don’t think it has to be that way,” he said. (Re­pub­li­can law­mak­ers have been con­sid­er­ing cuts to fed­er­al fund­ing for Med­ic­aid.) “When we adopt cut­ting-edge tech­nolo­gies and make tough but fair ne­go­ti­a­tions with in­dus­try, we can cut costs and im­prove pa­tient care.”

A bi­par­ti­san piece of leg­is­la­tion pro­posed this week would pro­hib­it phar­ma com­pa­nies from re­ceiv­ing tax de­duc­tions for di­rect-to-con­sumer drug ad­ver­tis­ing, a bill that could gen­er­ate sav­ings to off­set the cost of a sep­a­rate mea­sure to change the IRA's "pill penal­ty."

Reps. Greg Mur­phy (R-NC), Ang­ie Craig (D-MN), Nick Be­gich (R-AK), and Hillary Scholten (D-MI) on Mon­day an­nounced their in­tro­duc­tion of the "No Hand­outs for Drug Ad­ver­tise­ments Act," which would make the tax changes. A sim­i­lar Sen­ate bill was in­tro­duced last Ju­ly by Sen. Jeanne Sha­heen (D-NH).

"This leg­is­la­tion en­sures that re­sources are di­rect­ed to­wards low­er­ing drug costs and in­vest­ing in the re­search and de­vel­op­ment of new, life-sav­ing treat­ments," Mur­phy said.