Richard Paz­dur does­n't re­gret re­sign­ing back in De­cem­ber as di­rec­tor of the FDA's drug cen­ter, just weeks af­ter tak­ing the role.

Paz­dur, who spent more than two decades lead­ing the agen­cy's can­cer drug re­views, left the post of Cen­ter for Drug Eval­u­a­tion and Re­search di­rec­tor abrupt­ly. In an in­ter­view with End­points News, he point­ed to sev­er­al is­sues with FDA Com­mis­sion­er Mar­ty Makary's pri­or­i­ties and specif­i­cal­ly high­light­ed the un­prece­dent­ed po­lit­i­cal in­ter­fer­ence in the FDA's drug re­views.

The fire­wall be­tween each ad­min­is­tra­tion's po­lit­i­cal ap­pointees like Makary and the fed­er­al em­ploy­ees car­ry­ing out the drug re­views has ce­ment­ed the FDA as the lead­ing reg­u­la­tor in the world. But since the sec­ond Trump ad­min­is­tra­tion took of­fice, Paz­dur said, po­lit­i­cal ap­pointees have ex­pand­ed from the com­mis­sion­er lev­el to the cen­ter di­rec­tor lev­el. Po­lit­i­cal ap­pointees are now more com­mon­ly over­rul­ing re­view teams. Paz­dur not­ed that this is the first time in his FDA ca­reer in which a com­mis­sion­er called him to dis­cuss a spe­cif­ic ap­pli­ca­tion.

The FDA is get­ting clos­er to an­nounc­ing a di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, sources told End­points News, fol­low­ing the con­tro­ver­sial tenure of out­go­ing leader Vinay Prasad.

A lead­ing can­di­date for the post is Houman Hem­mati, peo­ple who spoke on con­di­tion of anonymi­ty told End­points. Hem­mati is a long­time biotech ex­ec­u­tive and oph­thal­mol­o­gist who has served in more than a dozen in­dus­try roles, posts heav­i­ly on so­cial me­dia and has raised ques­tions about the Covid-19 vac­cine.

Hem­mati didn’t re­spond to a re­quest for com­ment on Mon­day. An HHS spokesper­son told End­points, "No de­ci­sion has been made on the se­lec­tion of the next CBER di­rec­tor. We con­tin­ue to vet high­ly qual­i­fied can­di­dates."

Steve Ubl, the leader of the drug in­dus­try's pow­er­ful Wash­ing­ton, DC lob­by­ing group PhRMA, will step down af­ter more than a decade as CEO.

End­points News broke the news of his an­tic­i­pat­ed ex­it ear­li­er Wednes­day, and PhRMA con­firmed Ubl’s plans in a state­ment lat­er in the day.

In an in­ter­view with End­points, Ubl said he had orig­i­nal­ly dis­cussed his de­par­ture with a small cir­cle of PhRMA’s board about a year and a half ago, but agreed to stay through at least the first part of the new ad­min­is­tra­tion.

The an­nounce­ment comes ahead of a piv­otal US elec­tion this year that will de­cide con­trol of Con­gress, and the tim­ing will give PhRMA sev­er­al months to search for a new CEO. Last year, the group spent about $38 mil­lion on lob­by­ing ef­forts, ac­cord­ing to lob­by­ing dis­clo­sures.

The FDA has once again re­ject­ed Replimune’s on­colyt­ic virus ther­a­py to treat ad­vanced melanoma.

The Mass­a­chu­setts-based drug­mak­er had been push­ing for a re­con­sid­er­a­tion by the agency since the ther­a­py was first re­ject­ed last Ju­ly. At the time, it ar­gued that the FDA's com­plete re­sponse let­ter came out of left field af­ter what it thought were pro­duc­tive dis­cus­sions with the agency.

The FDA's orig­i­nal re­jec­tion raised is­sues about the com­pa­ny's de­sign and en­roll­ment for its piv­otal tri­al. In a new re­jec­tion let­ter pub­lished Fri­day, the agency raised the same is­sues and said that re­view­ers "unan­i­mous­ly de­ter­mined da­ta pre­sent­ed are in­suf­fi­cient to con­clude sub­stan­tial ev­i­dence of ef­fec­tive­ness" for treat­ing un­re­sectable ad­vanced cu­ta­neous melanoma.

Replimune's sec­ond com­plete re­sponse let­ter for its can­cer ther­a­py last week is al­ready lead­ing to mul­ti­ple rounds of lay­offs and ex­is­ten­tial ques­tions about the com­pa­ny's fu­ture un­less it can fig­ure out a path for­ward with the FDA, CEO Sushil Pa­tel told End­points News in an ex­clu­sive in­ter­view.

The on­colyt­ic virus ther­a­py RP1 is in­tend­ed to treat ad­vanced melanoma and is the on­ly ad­vanced drug in Mass­a­chu­setts-based Replimune's pipeline. Pa­tel con­ced­ed that both CRLs, the first of which was is­sued in Ju­ly, were large­ly the same. They raised ques­tions about the piv­otal tri­al's de­sign and the ex­tent to which Bris­tol My­ers Squib­b's Op­di­vo helped the ex­per­i­men­tal ther­a­py. But he ques­tioned the agen­cy's rea­son­ing and point­ed to po­ten­tial po­lit­i­cal in­volve­ment in the lat­est de­ci­sion.