Stephen Hahn (AP Images)

As he wraps stormy FDA tenure, Hahn ad­mits 'there was a sub­stan­tial amount of pres­sure' from White House — re­port

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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

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The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

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.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

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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.

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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.

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