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

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.