Last sum­mer, as drug­mak­ers rushed to test and de­liv­er the first Covid-19 vac­cines in hopes of tam­ing a rag­ing pan­dem­ic, FDA com­mis­sion­er Stephen Hahn re­peat­ed­ly re­as­sured the pub­lic that he will fight for sci­ence and fend off any politi­ciza­tion. At one point in Au­gust — just be­fore he would ap­pear along­side Pres­i­dent Don­ald Trump in a con­tro­ver­sial event an­nounc­ing the emer­gency use au­tho­riza­tion of con­va­les­cent plas­ma — he told a re­porter that “I’ve had ab­solute­ly no pres­sure from any­one.”

But as his brief, tu­mul­tuous tenure at the agency comes to an end, Hahn is look­ing back and cast­ing that time in a much dif­fer­ent light.

In ex­it in­ter­views with Politi­co and Bloomberg on Tues­day, Hahn de­scribed a “clash of cul­tures” with the Trump ad­min­is­tra­tion, which he de­scribed as “dereg­u­la­to­ry.” The in­flu­ence of the elec­tion year weighed heav­ier than ex­pect­ed, he not­ed.

“I heard loud and clear from the White House — Pres­i­dent Trump and oth­ers — that they want­ed FDA to move faster,” he told Politi­co.

Trump made his im­pa­tience with the FDA am­ply clear, de­cry­ing a “deep state” with­in the agency that he said was slow­ing down a Covid-19 vac­cine, in­sin­u­at­ing that the rea­son no vac­cine was au­tho­rized be­fore the elec­tion was be­cause “pol­i­tics gets in­volved,” and boast­ing “no pres­i­dent’s ever pushed them like I’ve pushed them.” As late as De­cem­ber, he lam­bast­ed the FDA was a “big, old, slow tur­tle” and called on Hahn to “stop play­ing games.”

“With time, par­tic­u­lar­ly over mid- to last sum­mer and then in­to fall, there was a sub­stan­tial amount of pres­sure,” Hahn ad­mit­ted.

Af­ter com­ing un­der at­tack from the sci­en­tif­ic com­mu­ni­ty for cit­ing in­ac­cu­rate num­bers on the ef­fec­tive­ness of con­va­les­cent plas­ma, Hahn earned plau­dits for stand­ing his ground on safe­ty fol­low-up from clin­i­cal tri­als. De­spite the De­part­ment of Health and Hu­man Ser­vices’ as­ser­tion of au­thor­i­ty and the White House’s ini­tial re­jec­tion of the up­dat­ed guid­ance (it lat­er re­lent­ed) — which asked for two-month fol­low-up and thus pre­clud­ed any hope of hav­ing a vac­cine ready for re­view in ear­ly No­vem­ber — the FDA man­aged to push it through by fram­ing it as rec­om­men­da­tions and com­mu­ni­cat­ing ear­ly with the com­pa­nies.

But the HHS’ at­tempt­ed pow­er grab didn’t stop there, with Sec­re­tary Alex Azar is­su­ing new poli­cies right down to the twi­light of the new gov­ern­ment, in­clud­ing a push to con­duct reg­u­lar re­views on ca­reer staffers and set term lim­its — an idea Hahn said he was not con­sult­ed on.

From his Q&A with Bloomberg:

My ma­jor con­cern about that was that it has such far-reach­ing im­pli­ca­tions on pub­lic health and our mis­sion, but al­so by the way, the mis­sion of CDC, CMS, etc. That re­quired a dis­cus­sion. What would in­dus­try think about this? What would stake­hold­er groups, what would pa­tient groups think?

If, for ex­am­ple, an FDA cen­ter di­rec­tor knew his or her term was up, and it was a sit­u­a­tion like this past year, would there be even sub­con­scious pres­sure to make a de­ci­sion one way or the oth­er — know­ing that the ul­ti­mate au­thor­i­ty al­low­ing you to stay in your po­si­tion rest­ed with the sec­re­tary of Health and Hu­man Ser­vices?

The ex­pe­ri­ence in Wash­ing­ton DC has left Hahn, who came in­to the job with a ré­sumé span­ning top re­search in­sti­tu­tions but vir­tu­al­ly no po­lit­i­cal back­ground, an ad­vo­cate for more FDA in­de­pen­dence — al­though he stopped short of com­plete­ly en­dors­ing calls for the agency to be a stand­alone en­ti­ty sep­a­rate from HHS.

“There’s a lot of dif­fer­ent mod­els out there, but I think giv­en what we’ve seen over the last year, par­tic­u­lar­ly in the pub­lic health emer­gency, re­al­ly bring this is­sue in­to the fore,” Hahn said to Politi­co, adding in his Bloomberg in­ter­view: “I would be in fa­vor of that if there was the ap­pro­pri­ate bal­ance be­tween over­sight and in­de­pen­dence.”

Biden, who is set to be in­au­gu­rat­ed this morn­ing, has tapped vet­er­an FDA of­fi­cial Janet Wood­cock as Hahn’s in­ter­im suc­ces­sor. Hahn said he will be tak­ing some time off be­fore de­cid­ing on next steps.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.