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

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

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Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

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In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.