A slim­mer FDA: White House pro­pos­es 30% cut to head­count un­der re­or­ga­ni­za­tion

Un­der a sweep­ing new plan to re­or­ga­nize gov­ern­ment agen­cies it deems in­ef­fi­cient, the Trump ad­min­is­tra­tion said Thurs­day it wants to re­move food safe­ty from the FDA’s purview — along with $1.3 bil­lion in re­sources and 5,000 of the agency’s staff.

The pro­pos­al would slim down the FDA’s re­spon­si­bil­i­ties to on­ly in­clude drugs, de­vices, bi­o­log­ics, to­bac­co, di­etary sup­ple­ments, and cos­met­ics. And the agency over­haul would come with a new moniker: the Fed­er­al Drug Ad­min­is­tra­tion.

The pro­pos­al is part of a broad­er plan la­belled “De­liv­er­ing Gov­ern­ment So­lu­tions in the 21st Cen­tu­ry,” a 132-page mar­ket­ing doc­u­ment that de­tails a wish-list of re­forms at the De­part­ment of Health and Hu­man Ser­vices.  The re­port is meant to tack­le is­sues Pres­i­dent Trump out­lined in a 2017 ex­ec­u­tive or­der, which fo­cused on re­duc­ing “du­pli­ca­tion and re­dun­dan­cy” and im­prov­ing “ef­fi­cien­cy, ef­fec­tive­ness, and ac­count­abil­i­ty of the ex­ec­u­tive branch.”

The re­or­ga­ni­za­tion would shift rough­ly 5,000 FDA em­ploy­ees out of the agency to join about 9,200 US­DA staffers. The new group would be called the “Fed­er­al Food Safe­ty Agency,” and it would fall un­der the US­DA’s man­date, not the FDAs. That would take a sig­nif­i­cant slice out FDA’s to­tal em­ploy­ee count, which cur­rent­ly stands at 17,468 peo­ple.

In­ter­est­ing­ly, the pro­pos­al al­so sug­gests the FDA would be con­tribut­ing $1.3 bil­lion in bud­get dol­lars, while the US­DA would on­ly toss in $1 bil­lion.

The FDA along with US­DA’s Food Safe­ty and In­spec­tion Ser­vice (FSIS) are the two main fed­er­al food safe­ty agen­cies now. The White House re­port de­scribes their arrange­ment as “il­log­i­cal, frag­ment­ed, and du­plica­tive”. From the re­port:

For ex­am­ple: while FSIS has reg­u­la­to­ry re­spon­si­bil­i­ty for the safe­ty of liq­uid eggs, FDA has reg­u­la­to­ry re­spon­si­bil­i­ty for the safe­ty of eggs while they are in­side their shells; FDA reg­u­lates cheese piz­za; but if there is pep­per­oni on top, it falls un­der the ju­ris­dic­tion of FSIS; FDA reg­u­lates closed-faced meat sand­wich­es, while FSIS reg­u­lates open-faced meat sand­wich­es.

No big re-org will hap­pen with­out Con­gress hav­ing its say, of course — a fact the White House takes note of. “Ful­ly in­te­grat­ing FSIS and the food safe­ty func­tions of FDA would ul­ti­mate­ly re­quire a rec­on­cil­i­a­tion of un­der­ly­ing leg­isla­tive au­thor­i­ties and reg­u­la­to­ry ap­proach­es,” the re­port states.

Mar­garet We­ichert, the deputy di­rec­tor for man­age­ment at the White House Of­fice of Man­age­ment and Bud­get, ac­knowl­edged in a call with re­porters that the changes “will not hap­pen overnight,” but hopes some of the lan­guage can serve as the “be­gin­ning of a na­tion­al di­a­logue on gov­ern­ment re­form.”

What’s cer­tain is that Scott Got­tlieb, the na­tion’s 23rd Com­mis­sion­er of Food and Drugs, has tak­en an es­pe­cial­ly per­son­al in­ter­est in his role as guardian of the food sup­ply with reg­u­lar tweets and com­mu­niques to the pub­lic on mat­ters from prop­er cook­ing tech­niques and re­call no­tices, and he isn’t like­ly to give up that re­spon­si­bil­i­ty so fast.


Im­age: The White House Shut­ter­stock

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

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