The FDA on Tues­day named long­time can­cer chief Richard Paz­dur as di­rec­tor of the Cen­ter for Drug Eval­u­a­tion and Re­search.

The ap­point­ment comes just over a week af­ter George Tid­marsh's sud­den res­ig­na­tion as CDER di­rec­tor. Tid­marsh had stepped down fol­low­ing re­ports that he was the sub­ject of an in­ter­nal in­ves­ti­ga­tion around claims that he used his po­si­tion to take re­venge on a for­mer busi­ness as­so­ciate.

Paz­dur, the found­ing di­rec­tor of the FDA's On­col­o­gy Cen­ter of Ex­cel­lence, will now al­so lead the cen­ter that reg­u­lates over-the-counter and pre­scrip­tion drugs. He will take over at a crit­i­cal time for CDER, as Com­mis­sion­er Mar­ty Makary seeks to take a more dereg­u­la­to­ry stance and lead­er­ship has hit the ex­its en masse.

Over the last decade, FDA com­mis­sion­ers have gen­er­al­ly steered clear from the nit­ty-grit­ty of drug ap­pli­ca­tions, the opin­ions of drug re­view staff, or try­ing to bend laws that pro­hib­it the agency from at­tempt­ing to in­flu­ence the price of drugs.

Com­mis­sion­er Mar­ty Makary, how­ev­er, has al­ready stretched many of those pri­or con­ven­tions. And on Thurs­day, speak­ing at the Milken In­sti­tute's Fu­ture of Health con­fer­ence, he laid out a more ex­pan­sive role for the of­fice that would in­volve him in de­ci­sions and de­tails that oth­er top lead­ers of the agency have his­tor­i­cal­ly avoid­ed.

"We have to chal­lenge deeply-held as­sump­tions," Makary said at the event. "If you don't care about the op­er­a­tions of the agency or the im­pact you can have, the job is very easy. You can just show up at cock­tail re­cep­tions."

Eli Lil­ly’s oral obe­si­ty pill or­for­glipron was among the next six drugs to win the FDA's Na­tion­al Pri­or­i­ty Vouch­er, of­fer­ing the GLP-1 drug can­di­date a path to po­ten­tial ap­proval in as lit­tle as one month.

The FDA on Thurs­day un­veiled the batch of re­cip­i­ents un­der the new vouch­er pro­gram, which aims to sig­nif­i­cant­ly short­en the typ­i­cal 10 to 12-month re­view times.

The sec­ond batch, fol­low­ing Oc­to­ber's roll­out of the first nine vouch­ers, will go to:

WASH­ING­TON, DC — The FDA is mak­ing a con­cert­ed ef­fort to in­crease ac­cess to hor­mone re­place­ment ther­a­pies (HRTs) for women by call­ing on their mak­ers to ap­ply to re­move the boxed warn­ings the agency added to their la­bels in 2003.

HHS said Mon­day that the FDA mis­ap­plied the boxed warn­ings fol­low­ing stud­ies un­der the NIH-run Women’s Health Ini­tia­tive (WHI). Those stud­ies were stopped ear­ly due to ad­verse events, in­clud­ing an in­creased risk of breast can­cer in one study and an in­creased risk of stroke in an­oth­er, af­ter an av­er­age of five to sev­en years of fol­low-up, ac­cord­ing to an FDA re­lease.

The FDA told Bio­haven its study us­ing re­al-world da­ta “would like­ly be in­ad­e­quate to pro­vide sub­stan­tial ev­i­dence of ef­fec­tive­ness” when it was pro­posed, ac­cord­ing to an agency re­jec­tion let­ter for the rare dis­ease drug tro­r­ilu­zole.

Ear­li­er this week, the reg­u­la­tor re­ject­ed Bio­haven’s drug, shut­ting down the com­pa­ny’s sec­ond at­tempt to get ap­proval of a ther­a­py for a neu­rode­gen­er­a­tive dis­ease called spin­ocere­bel­lar atax­ia. In 2023, the FDA re­fused to even re­view Bio­haven’s ap­pli­ca­tion for tro­r­ilu­zole af­ter the drug failed a place­bo-con­trolled tri­al.

The let­ter was post­ed the same week Bio­haven an­nounced its drug was re­ject­ed, mark­ing one of the quick­est turn­arounds for the agency to make a com­plete re­sponse let­ter pub­lic as part of its wider push to share why drugs were not ap­proved.