With the FDA run­ning out of funds, health­care groups warn that the drug ap­proval process will soon be de­railed

The longest ever US gov­ern­ment shut­down has forced the FDA to fur­lough work­ers and hun­ker down around key tasks. But with cash run­ning out and their hands tied on gath­er­ing new fees, the agency is on the verge of see­ing its work on new drug ap­provals be­gin to grind to a halt. And a host of promi­nent health­care groups — in­clud­ing some well known sci­en­tif­ic or­ga­ni­za­tions — are warn­ing that the shut­down now threat­ens the na­tion’s ac­cess to cru­cial new ther­a­pies.

In a let­ter to Pres­i­dent Trump, Speak­er Nan­cy Pelosi and oth­er law­mak­ers on Tues­day, 46 ad­vo­ca­cy or­ga­ni­za­tions and pro­fes­sion­al so­ci­eties called for an end to the shut­down and asked that the FDA re­turn to full ca­pac­i­ty be­cause the health of Amer­i­cans is at stake.

“(W)e fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy,” they wrote. “The on­go­ing gov­ern­ment shut­down forces the FDA to make dif­fi­cult choic­es re­gard­ing to which es­sen­tial func­tions its great­ly re­duced re­sources are di­rect­ed. These are de­ci­sions that nev­er should have to be made — the health and safe­ty of Amer­i­cans to­day should nev­er be weighed against the prospect of new life-sav­ing ther­a­pies for pa­tients…”

“While we ap­plaud Com­mis­sion­er Got­tlieb, FDA lead­er­ship, and ‘es­sen­tial staff’ for tru­ly hero­ic work to keep many as­pects of its mis­sion func­tion­ing, we fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy.”

The group in­cludes AS­CO and the Na­tion­al Or­ga­ni­za­tion for Rare Dis­eases, which play a role in fo­cus­ing at­ten­tion on im­por­tant new sci­en­tif­ic de­vel­op­ments in their re­spec­tive fields.

Ex­perts sug­gest the FDA has rough­ly 2 to 3 months of fund­ing on the de­vice side. The drug side is less flush, with about a month of fund­ing left. Sub­mis­sions made pri­or to the shut­down on De­cem­ber 22 will be dealt with as usu­al, while sub­mis­sions made af­ter that date are placed in queue and will like­ly not be worked on un­til the shut­down is re­solved, ac­cord­ing to Jef­feries an­a­lysts, who added that if the shut­down con­tin­ues be­yond a month from now, the FDA will on­ly be able to fo­cus on es­sen­tial mat­ters such as food/prod­uct/man­u­fac­tur­ing safe­ty and pri­or­i­ty re­view.

Over the past few years, the FDA has grown in­creas­ing­ly pop­u­lar with bio­phar­ma com­pa­nies, which have en­joyed the most re­spon­sive agency they’ve ever known. The fo­cus un­der Scott Got­tlieb has been on ac­cel­er­at­ed ap­provals and rapid re­sponse to hur­ry along new drugs from es­tab­lished com­pa­nies. And all of that is be­ing jeop­ar­dized by the shut­down af­ter a pe­ri­od of climb­ing pro­duc­tiv­i­ty and record drug ap­provals.

If the shut­down con­tin­ues for the fore­see­able fu­ture, “the agency will have some al­go­rithm of how they go through the queue with drugs/agents with pri­or­i­ty re­view and/or oth­er high need tak­ing pri­or­i­ty…our es­ti­mate is a PDU­FA could get de­layed by per­haps the length of time from when funds dry up (next month) to when the gov­ern­ment is back open,” Jef­feries an­a­lysts said.

A sep­a­rate let­ter from more than 280 or­ga­ni­za­tions rep­re­sent­ing health, the en­vi­ron­ment, doc­tors and pa­tients al­so urged Pres­i­dent Trump last week to re­open the gov­ern­ment.

“Sev­er­al agen­cies’ abil­i­ty to pro­vide crit­i­cal ser­vices, rang­ing from food and en­vi­ron­men­tal risk in­spec­tions to health ser­vices, have al­ready been dras­ti­cal­ly re­duced or are threat­ened if the shut­down con­tin­ues. We fear a pro­longed shut­down will cause need­less suf­fer­ing and have long-last­ing health con­se­quences,” they wrote.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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