Opin­ion: Biden needs to step up and nom­i­nate an FDA com­mis­sion­er

Enough with the wait­ing. Pres­i­dent Joe Biden needs to em­brace the FDA dur­ing this pan­dem­ic and kick­start the Sen­ate con­fir­ma­tion process for the next per­ma­nent com­mis­sion­er.

And this needs to hap­pen quick­ly. There are plen­ty of qual­i­fied can­di­dates for the role out­side of act­ing com­mis­sion­er Janet Wood­cock and Josh Sharf­stein. Biden needs to move fast not be­cause the bio­phar­ma world strug­gles with even the per­cep­tion of FDA un­cer­tain­ty (it does), but be­cause thou­sands of FDA em­ploy­ees have been deal­ing with four years of po­lit­i­cal smears while putting in over­time to re­view thou­sands of Covid-19 drug and vac­cine tri­als, and to au­tho­rize three safe vac­cines in record time.

Their hard work should be re­paid with some good news and longer-term di­rec­tion, and it’s time the pub­lic saw state­ments and com­ments from the FDA com­mis­sion­er, not the act­ing com­mis­sion­er.

The po­lit­i­cal pres­sure and name call­ing (Trump once re­ferred to the FDA as a “big, old, slow tur­tle,”) have come and gone. Now, the FDA must wait (com­ing up on three months, plus at least an­oth­er cou­ple for the con­fir­ma­tion process) be­fore they get an of­fi­cial leader and po­lit­i­cal staff they can look to for en­cour­age­ment rather than em­bar­rass­ment from for­mer FDA com­mis­sion­er Stephen Hahn’s ex­ag­ger­a­tion of the ben­e­fits of con­va­les­cent plas­ma and sub­se­quent apol­o­gy tour, and the fir­ing of a for­mer Wash­ing­ton Times ed­i­tor turned com­mu­ni­ca­tions leader just 11 days in­to the job.

As many at the agency have ex­plained in pub­lic and pri­vate, it doesn’t re­al­ly mat­ter who’s at the very top (un­less it’s Scott Got­tlieb, every­one at FDA adores Dr. Got­tlieb) be­cause the com­mis­sion­er’s job is most­ly about serv­ing as the pub­lic face of the agency, and less about dri­ving the dai­ly agen­da, most of which is set months and years in ad­vance.

But it does mat­ter that there’s some­one in that top slot who’s a cham­pi­on for pub­lic safe­ty, com­pe­tent and who un­der­stands how the agency works, and what that role can and can­not do. No one wants an FDA com­mis­sion­er who needs to learn the ropes over the first 3-6 months, on­ly to leave af­ter a year.

So what’s the hold up for Biden?

For a pres­i­dent who has made clear his in­ten­tion to re­move his pre­de­ces­sor’s po­lit­i­cal traps around pub­lic health, and to res­ur­rect the bat­tered CDC, Biden re­mained mum on FDA and his fail­ure to name FDA’s per­ma­nent com­mis­sion­er seems to be very much about pol­i­tics.

At least four Sen­ate De­moc­rats – Mag­gie Has­san of New Hamp­shire, Ed Markey of Mass­a­chu­setts, Joe Manchin of West Vir­ginia and Cather­ine Cortez Mas­to of Neva­da – have pre-empt­ed Biden’s nom­i­na­tion and voiced their op­po­si­tion to the lead­ing con­tender for the job, Wood­cock.

The opi­oid epi­dem­ic re­mains at the fore­front of some of the sen­a­tors’ minds, and right­ly so, con­sid­er­ing the dev­as­ta­tion across the coun­try. Oth­ers have raised con­cerns on in­dus­try in­flu­ence, but Got­tlieb did a sol­id job of show­ing how pri­or in­dus­try ex­pe­ri­ence does not nec­es­sar­i­ly re­flect on life as a com­mis­sion­er.

What those sen­a­tors fail to ac­count for in their op­po­si­tion to Wood­cock is that the FDA is well past the days when a com­mis­sion­er is mak­ing uni­lat­er­al de­ci­sions for the en­tire agency, or when in­dus­try in­flu­ence might tip the scale. The bio­phar­ma in­dus­try owns the scale. Al­most 70% of the FDA’s bud­get for drugs is from in­dus­try user fees. Work­ing with in­dus­try isn’t just in the job de­scrip­tion, it’s a large part of the rea­son FDA ex­ists now. But it’s the oth­er, much more im­por­tant part of FDA’s role, the part where the FDA pro­tects the Amer­i­can pub­lic and Amer­i­cans can trust the voice of the com­mis­sion­er. That should push Biden to move for­ward with a per­ma­nent com­mis­sion­er.

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.

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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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%.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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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.