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‘Peo­ple will die’: End of NIH grants guts work Read in browser
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top stories
1. Firings sweep across FDA as former leaders lament the gutting of drug agency
2. ‘It’ll be a challenge’: BIO chief Crowley addresses seismic FDA overhaul
3.
in focus
‘People will die’: End of NIH grants guts work between academics and companies to counter next pandemic
4. What’s next after Marks? At FDA, questions over more top exits and future vision for drug agency
5. Marks’ exit at FDA rattles an already teetering biotech industry
6. RFK Jr. has long criticized drug ads. He just slashed the FDA office that regulates them
7. Federal judge nixes FDA's lab-developed test rule, says it exceeded agency's authority
8. FDA sets new date for opioid-focused advisory meeting after earlier delay
Zachary Brennan
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The dust is beginning to settle on catastrophic cuts to the FDA's White Oak campus in Maryland, with sources saying as many as 800 in CDER were let go yesterday, and a new acting replacement for CBER chief Peter Marks was added. While HHS is aiming for 3,500 FDA cuts across the board, we're hearing of firings of not only senior leadership — like FDA's chief medical officer and director of the Office of New Drugs — but deep cuts to the offices of the chief scientist, manufacturing quality, drug promotion (see more below), all three of the employees implementing Trump's Right to Try law, and many more on the media affairs, communications and policy sides of FDA. Be sure to stay in touch as we learn more — you can find me on Signal at zacharybrennan.20 or email me.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
1
by Zachary Brennan

Mass fir­ings and forced res­ig­na­tions swept through the FDA on Tues­day, as part of thou­sands of planned job cuts at fed­er­al health agen­cies be­ing im­ple­ment­ed by the Trump ad­min­is­tra­tion.

Some em­ploy­ees who showed up to work at the FDA's main White Oak cam­pus on Tues­day found out they had been fired when they at­tempt­ed to check in at se­cu­ri­ty, on­ly to find out that their badges no longer worked and their jobs were gone. They were then es­cort­ed by se­cu­ri­ty to col­lect their be­long­ings. The scenes were de­scribed to End­points News by sev­er­al peo­ple who wit­nessed them, and re­quest­ed anonymi­ty.

Oth­ers, such as CDER Of­fice of New Drugs Di­rec­tor Pe­ter Stein, were of­fered a new, hasti­ly cre­at­ed role in a dif­fer­ent de­part­ment — or the choice to quit.

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John Crowley, BIO CEO
2
by Max Bayer

WASH­ING­TON — The size and scope of the FDA that be­gan Tues­day won’t be the same as the day nears a bru­tal con­clu­sion for agency staffers that were laid off or forced to re­sign.

Sit­ting in a cor­ner of­fice clos­er to the pow­er bro­kers that craft­ed the re­struc­tur­ing, BIO CEO John Crow­ley tried not to cat­a­stro­phize.

“It’ll be a chal­lenge,” he said in an ex­clu­sive in­ter­view with End­points News. “We take the FDA as we find it and this is the FDA we have to­day.”

Few ar­eas of the agency were spared as part of the Trump ad­min­is­tra­tion's sweep­ing cuts. Chief med­ical of­fi­cer Hi­lary Marston was fired; the head of the Of­fice of New Drugs, Pe­ter Stein, was placed on ad­min­is­tra­tive leave; and the Of­fice of Me­dia Af­fairs was dec­i­mat­ed by cuts. There were deep cuts at the FDA’s Of­fice of Man­u­fac­tur­ing Qual­i­ty and im­muno-on­col­o­gy staff with­in CBER.

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A Johnson & Johnson lab tech researches Covid-19 (AP Photo/Virginia Mayo)
Endpoints In Focus
3
by Ryan Cross

On Tues­day, drug dis­cov­er­er and biotech en­tre­pre­neur Al­pha Lee told sci­en­tists at a chem­istry meet­ing about a new mol­e­cule to com­bat the Zi­ka virus. There are no treat­ments de­signed to stop the mos­qui­to-borne in­fec­tion, which can cause birth de­fects. Af­ter three years of work, Lee and a team of col­lab­o­ra­tors had made a com­pound that shut down an en­zyme that’s es­sen­tial for Zi­ka virus repli­ca­tion.

But his ex­cite­ment was short-lived. Af­ter the con­fer­ence ses­sion end­ed, Lee checked his email and saw that the $67 mil­lion fed­er­al fund­ing sup­port­ing the work and sev­er­al oth­er an­tivi­ral pro­grams had been ter­mi­nat­ed.

“The end of the pan­dem­ic pro­vides cause to ter­mi­nate COVID-re­lat­ed grant funds. These grant funds were is­sued for a lim­it­ed pur­pose: to ame­lio­rate the ef­fects of the pan­dem­ic. Now that the pan­dem­ic is over, the grant funds are no longer nec­es­sary,” said the email, which was re­viewed by End­points News.

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4
by Zachary Brennan

A top of­fi­cial pushed out over vac­cines. Se­nior staff head­ing for the ex­it. Thou­sands of work­ers tar­get­ed for fir­ing. A new com­mis­sion­er who has yet to vis­i­bly take charge. And an HHS sec­re­tary whose views on vac­cines run counter to es­tab­lished sci­ence.

Af­ter sev­er­al tu­mul­tuous weeks at the FDA, many in­side and out­side the agency are won­der­ing: What could come next?

Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search Di­rec­tor Pe­ter Mark­s' Fri­day ex­it was just the high­est-pro­file of a num­ber of key staff de­par­tures. Oth­er top of­fi­cials who have left in the past month in­clude Lo­la Fashoyin-Aje, head of cell and gene ther­a­py clin­i­cal eval­u­a­tion, Heather Lom­bar­di, head of cell ther­a­pies, Heather Erd­man, as­so­ciate di­rec­tor of qual­i­ty as­sur­ance, and Vaishali Popat, branch chief in cell and gene ther­a­pies, ac­cord­ing to sources.

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Peter Marks (Susan Walsh/Pool via AP Images)
5
by Drew Armstrong, Max Gelman, Kyle LaHucik

The de­par­ture of one of the FDA’s high­est-pro­file reg­u­la­tors, whose ca­reer was de­fined by ad­vanc­ing new tech­nolo­gies to pa­tients, rat­tled in­vestors and com­pa­nies who were al­ready feel­ing in­se­cure.

Fri­day’s shock ex­it of Pe­ter Marks, the di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, was met by dis­may across the in­dus­try. Marks was best known by the broad­er pub­lic for his work on Covid-19 vac­cines dur­ing the pan­dem­ic — which made him a tar­get for HHS Sec­re­tary Robert F. Kennedy Jr., who has tak­en mul­ti­ple steps to un­der­mine vac­cine re­search and trust.

But as the head of the bi­o­log­ics cen­ter, Marks wa