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

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.