Endpoints News
Judge grants new nationwide block on NIH payment cuts  Read in browser
Endpoints News
Thank you for reading, dupa dupackia!
basic
UPGRADE
Wednesday
12 March, 2025
US PHARMA AND BIOTECH SUMMIT
Join top executives, investors, and policymakers at the US Pharma & Biotech Summit for exclusive insights and discussions on the biggest trends impacting the industry. Early bird rates end March 16 — register now.
top stories
1. Trump administration reverses lease termination for major FDA quality lab in St. Louis
2. Exclusive: FDA blocks drug and device reviewers from taking HHS' buyout offer
3. FDA’s medical review departments remain untouched (for now) by Musk’s cuts
4. What the FDA, NIH hearings tell us about drug and health policy under Trump
5. Judge grants new nationwide block on NIH payment cuts 
6. FDA approves Neurotech cell therapy to slow a rare degenerative eye disease 
7. Novo Nordisk will join legal row over FDA's removal of semaglutide from shortage list
Zachary Brennan
.

On our busy agenda for the rest of the week, three main items: 1) House and Senate Republicans need to come together to pass a continuing resolution to keep the federal government open. If they can't, stay tuned for furloughs. The CR keeps the FDA's funding levels at the same levels as during the Biden administration, and the rare pediatric PRV reauthorization is not included. 2) FDA commissioner nominee Marty Makary and NIH director nominee Jay Bhattacharya face Senate HELP committee votes tomorrow. They're expected to sail through. 3) Trump's picks to lead CMS and the CDC will face Senate grillings on Thursday and Friday, respectively.

.
Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
Elon Musk (L) and President Donald Trump in the Oval Office (Alex Brandon/AP Images)
1
by Zachary Brennan

Two days af­ter an­nounc­ing plans to shut down an FDA lab de­vot­ed to en­sur­ing the US drug sup­ply re­mains safe and po­tent, the Trump ad­min­is­tra­tion has changed plans and will leave the lab open, End­points News has learned.

The St. Louis lab, known as the Of­fice of Test­ing and Re­search, is one of the drug agency’s most im­por­tant fa­cil­i­ties for en­sur­ing drugs are of high qual­i­ty. In ad­di­tion to its day-to-day work, the lab has been called in to in­ves­ti­gate high-pro­file drug safe­ty is­sues.

In 2008, for ex­am­ple, it led a probe in­to con­t­a­m­i­nat­ed sup­plies of the blood thin­ner he­parin, which like­ly killed dozens of Amer­i­cans and was even­tu­al­ly traced back to a sup­pli­er in Chi­na. More re­cent­ly, it led a probe in­to com­mon heart­burn med­ica­tions that were found to have un­safe lev­els of ni­trosamine, a car­cino­gen. That in­ves­ti­ga­tion helped lead to pop­u­lar prod­ucts like Zan­tac and re­lat­ed over-the-counter drugs be­ing pulled from shelves.

Click here to continue reading
2
by Zachary Brennan

The FDA told staff on Mon­day that re­view­ers of med­ical prod­ucts and in­spec­tors of man­u­fac­tur­ing fa­cil­i­ties can­not take the buy­out of­fer cir­cu­lat­ed on Fri­day from HHS that would've pro­vid­ed as much as $25,000 in sev­er­ance, three FDA of­fi­cials con­firmed to End­points News.

The carve­outs for staff fund­ed by in­dus­try user fee dol­lars show the ex­tent to which the FDA and HHS are not tar­get­ing drug and de­vice re­view­ers in the Trump ad­min­is­tra­tion's wider gov­ern­ment staffing cuts. The move al­so will help en­sure that all on­go­ing drug and de­vice re­view time­lines re­main on sched­ule.

The agency email on Mon­day, ac­cord­ing to the three sources, not­ed that "in­el­i­gi­ble po­si­tions" for the HHS buy­outs in­clude: "In­spec­tors and in­ves­ti­ga­tors in the Of­fice of In­spec­tion and In­ves­ti­ga­tions in­clud­ing po­si­tions with­in the Of­fice of Crim­i­nal In­ves­ti­ga­tion; Re­view­ers in CDER, CBER, CDRH, CVM, CTP and OC of­fices; phys­i­cal se­cu­ri­ty po­si­tions; cy­ber­se­cu­ri­ty po­si­tions; and all PHS Com­mis­sioned Corps Of­fi­cers."

Click here to continue reading
3
by Zachary Brennan

Since Pres­i­dent Don­ald Trump took of­fice, Elon Musk's De­part­ment of Gov­ern­ment Ef­fi­cien­cy has laid off thou­sands of gov­ern­ment work­ers through broad, sud­den cuts — some lat­er re­versed — that have thrown the op­er­a­tions of the gov­ern­ment in­to a pe­ri­od of un­cer­tain­ty.

That in­cludes plans to halve the In­ter­nal Rev­enue Ser­vice, and the wide­spread purge of the US Agency for In­ter­na­tion­al De­vel­op­ment, which will lose more than 80% of its staff. But for now, the FDA’s units re­spon­si­ble for re­view­ing new med­ical prod­ucts have re­mained un­touched — and may re­main so.

On Mon­day, days af­ter more than 83,000 HHS em­ploy­ees were of­fered a $25,000 buy­out pack­age to quit their jobs, FDA staff were told that work­ers in the agency’s units that re­view med­ical prod­ucts and in­spect man­u­fac­tur­ing fa­cil­i­ties wouldn’t be el­i­gi­ble, End­points News re­port­ed. Sub­se­quent­ly, two peo­ple fa­mil­iar with the agen­cy's op­er­a­tions told End­points that re­view­ers and in­spec­tors in the drug, bi­o­log­ics and de­vices cen­ters would like­ly be shield­ed from cuts.

Click here to continue reading
Robert F. Kennedy Jr. (Allison Bailey/NurPhoto via AP Images)
4
by Zachary Brennan

Pres­i­dent Don­ald Trump's nom­i­nees for NIH di­rec­tor and FDA com­mis­sion­er sailed through their re­spec­tive con­fir­ma­tion hear­ings this week, fac­ing few dif­fi­cult ques­tions and of­fer­ing few con­tro­ver­sial an­swers. But some of the views they ex­pressed may con­flict with the pri­or­i­ties of their new boss, Robert F. Kennedy Jr.

While NIH nom­i­nee Jay Bhat­tacharya and FDA pick Mar­ty Makary made fre­quent men­tion of Kennedy's "Make Amer­i­ca Healthy Again" slo­gan, both po­si­tioned them­selves as more mod­er­ate on sev­er­al cru­cial is­sues, such as vac­cines. And on oth­er ma­jor Kennedy pri­or­i­ties, like the in­flu­ence of the phar­ma in­dus­try, it was­n't clear from the hear­ings what they think.

Here are six take­aways from the hear­ings, and what they in­di­cate — and what's still un­known — about drug and health pol­i­cy in the Trump ad­min­is­tra­tion.

Click here to continue reading
5
by Nicole DeFeudis

A fed­er­al judge on Wednes­day blocked the NIH from is­su­ing a cap on in­di­rect cost pay­ments for grantees af­ter find­ing that the chal­lengers are like­ly to show the cuts con­flict with the law.

Judge An­gel Kel­ley in Mass­a­chu­setts grant­ed a na­tion­wide pre­lim­i­nary in­junc­tion af­ter hear­ing ar­gu­ments last month in three sep­a­rate law­suits brought by 22 states, sev­er­al uni­ver­si­ties and or­ga­ni­za­tions rep­re­sent­ing schools and hos­pi­tals. Kel­ley had pre­vi­ous­ly is­sued a tem­po­rary re­strain­ing or­der, which pre­vent­ed the cuts from tak­ing ef­fect while she con­sid­ered the de­tails of the case.

The fed­er­al gov­ern­ment can ap­peal the pre­lim­i­nary in­junc­tion while the cas­es pro­ceed in dis­trict court. It’s un­clear whether it plans to do so at this time.

Click here to continue reading
6