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

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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