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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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