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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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