Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top ca­reer staff at the FDA has vowed not to let pol­i­tics over­rule sci­ence when look­ing at vac­cine da­ta this fall. But Alex Azar, who hap­pens to be their boss’s boss, ap­par­ent­ly won’t even give them a chance to stand in the way.

In a new mem­o­ran­dum is­sued Tues­day last week, the HHS chief stripped the FDA and oth­er health agen­cies un­der his purview of their rule mak­ing abil­i­ty, as­sert­ing all such pow­er “is re­served to the Sec­re­tary.” Sheila Ka­plan of the New York Times first ob­tained and re­port­ed the de­tails of the Sep­tem­ber 15 bul­letin.

Azar’s sig­na­ture is now re­quired on all new rule­mak­ing, which are typ­i­cal­ly signed by agency lawyers and bu­reau­crats.

“This was sim­ply push­ing a re­set but­ton,” claimed Azar’s top aide Bri­an Har­ri­son to the Times. “This is good gov­er­nance and should have no op­er­a­tional im­pact.”

It’s not im­me­di­ate­ly clear what the im­pact on this or­der will have on the agency’s day-to-day op­er­a­tions — es­pe­cial­ly on rou­tine mat­ters where it has long en­joyed po­lit­i­cal in­de­pen­dence. An agency of­fi­cial not au­tho­rized to speak with the me­dia told the Times they’re still “de­ci­pher­ing what Mr. Azar’s memo would mean for their work.”

The move comes just days af­ter a group of high-pro­file FDA ca­reer ser­vants — in­clud­ing Pe­ter Marks, Jeff Shuren, and Janet Wood­cock — wrote in a USA To­day op-ed that “we will work with agency lead­er­ship to main­tain FDA’s stead­fast com­mit­ment to en­sur­ing our de­ci­sions will con­tin­ue to be guid­ed by the best sci­ence.”

By tak­ing au­thor­i­ty that was once the clear do­main of pro­fes­sion­al staff, the new memo is in line with the cen­tral­iza­tion of pow­er across the fed­er­al gov­ern­ment in the hands of Trump loy­al­ists. And crit­ics note that it blazes a path where the FDA could be side-stepped for an emer­gency use au­tho­riza­tion on an ear­ly coro­n­avirus vac­cine. Er­ic Topol, di­rec­tor at the Scripps Re­search In­sti­tute, spelled out on Twit­ter a po­ten­tial sce­nario with Pfiz­er’s can­di­date:

Low­ell Schiller

The pow­er grab by Azar has ev­i­dent­ly dri­ven at least one es­tab­lished ca­reer ser­vant to the ex­its. On Thurs­day, Politi­co re­port­ed that the FDA’s prin­ci­pal as­so­ciate com­mis­sion­er for pol­i­cy, Low­ell Schiller, left the agency last week. Schiller, a Scott Got­tlieb hire, signed near­ly every FDA no­tice on the fed­er­al reg­is­ter and played a cen­tral role in writ­ing the FDA’s Covid-19 guid­ance. (Up­date: Politi­co now re­ports the de­par­ture was un­re­lat­ed to the memo.)

Af­ter the Times pub­lished its sto­ry, an HHS spokesper­son took to Twit­ter to again re­fute any sug­ges­tion that the FDA’s work would be slowed down but did not ad­dress con­cerns that the new memo could be used to over­rule de­ci­sions by FDA staff. “The memo ma­ligned in this sto­ry is a good gov­er­nance, house­keep­ing ac­tion, which will not slow down the im­por­tant work of the FDA or any HHS di­vi­sion,” the tweet said. Lat­er on Sun­day, the agency put out a FAQ-style re­sponse to news sto­ries on the memo but did not pro­vide the memo’s ac­tu­al text.

The HHS memo is one of the most far-reach­ing ac­tions in a decades-old quest by hard-right Amer­i­can con­ser­v­a­tives to crip­ple the reg­u­la­to­ry pow­ers of pro­fes­sion­als in ex­ec­u­tive-branch agen­cies. De­spite be­ing a con­gres­sion­al­ly del­e­gat­ed au­thor­i­ty, Pres­i­dent Trump and his po­lit­i­cal al­lies rou­tine­ly frame the is­sue of as one of fed­er­al em­ploy­ees act­ing like “un­ac­count­able bu­reau­crats.” Last year, while Trump was sign­ing ex­ec­u­tive or­ders aimed at pair­ing back rule­mak­ing across sev­er­al agen­cies, his pre­pared re­marks stat­ed that “all too of­ten guid­ance doc­u­ments are a back door for reg­u­la­tors to ef­fec­tive­ly change the laws and vast­ly ex­pand their scope and reach.”

Scott Got­tlieb

Scott Got­tlieb, a con­ser­v­a­tive who won wide praise across the po­lit­i­cal spec­trum for his tenure as Trump’s first FDA com­mis­sion­er, fought the en­croach­ment on the agency’s rule­mak­ing abil­i­ty through­out his en­tire tenure. He used the pow­ers as a cud­gel against to­bac­co and va­p­ing in­dus­tries, and ac­cord­ing to the Times re­port, even signed one of the last or­ders on it, hop­ing that his sig­na­ture, rather than a low­er-rank­ing staffer’s, would give his mea­sure stay­ing pow­er on the books.

Azar, who has now as­sert­ed him­self as the ul­ti­mate rule mak­er at the FDA, is Trump’s sec­ond HHS sec­re­tary, tak­ing of­fice in 2018. He was named pres­i­dent of the US di­vi­sion of Eli Lil­ly in 2012 and served on BIO’s board. He de­part­ed Lil­ly in 2017 when CEO David Ricks re­vamped the org chart.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.