Stephen Hahn went be­fore a Sen­ate com­mit­tee Wednes­day and de­clared he’s fight­ing. “Every one of the de­ci­sions we have reached has been made by ca­reer FDA sci­en­tists based on sci­ence and da­ta, not pol­i­tics,” he ex­claimed, adding that “FDA will not per­mit any pres­sure from any­one to change that. I will fight for sci­ence.”

A few hours lat­er, he was un­der­mined by Pres­i­dent Don­ald Trump when a re­porter asked if he was okay with stricter vac­cine guide­lines that the FDA was said to be cook­ing up. “That has to be ap­proved by the White House. We may or may not ap­prove it. That sounds like a po­lit­i­cal move,” he de­cid­ed.

The re­marks set up an­oth­er crit­i­cal junc­ture for the agency and its be­lea­guered com­mis­sion­er, who has been work­ing over­time to bol­ster pub­lic con­fi­dence in the FDA and his lead­er­ship since Hahn’s dis­as­trous per­for­mance as­sist­ing the pres­i­dent tout false con­va­les­cent plas­ma fig­ures.

The pres­i­dent then ques­tioned the need to length­en the ap­proval time­line, fore­cast­ing “great re­sults” ahead and again fram­ing the FDA’s moves as po­lit­i­cal:

Be­cause when you have Pfiz­er, John­son and John­son, Mod­er­na, these great com­pa­nies com­ing up with the vac­cines and they’ve done test­ing and every­thing else. I’m say­ing, why would they have to be adding great length to the process.

It sound­ed to me, ex­treme­ly po­lit­i­cal. Why would they do this, when we come back with these great re­sults. And I think you will have those great re­sults.

The new FDA stan­dards re­port­ed­ly passed muster at HHS on Tues­day and there was an ex­pec­ta­tion that it would get a green light from the White House, ac­cord­ing to a Politi­co re­port that cites two sources fa­mil­iar with the time­line. Trump re­port­ed­ly spoke with HHS sec­re­tary Alex Azar be­fore the press con­fer­ence.

Un­der the new guid­ance, vac­cine de­vel­op­ers must fol­low at least half the par­tic­i­pants for 60 days fol­low­ing the sec­ond dose, as well as ac­crue five or more cas­es of se­vere Covid-19 in the place­bo group, be­fore they can seek an EUA.

It’s still pos­si­ble the new EUA rules are al­lowed to go in­to ef­fect by Trump. But for an agency ac­cus­tomed to bi­par­ti­san def­er­ence from its po­lit­i­cal su­pe­ri­ors, it’s now sail­ing in un­chart­ed wa­ters work­ing un­der a pres­i­dent who de­mands key de­ci­sions be rout­ed through a com­mand-and-con­trol struc­ture firm­ly con­trolled by him or trust­ed lieu­tenants. And by hav­ing Trump la­bel their work as “ex­treme­ly po­lit­i­cal,” it rais­es new ques­tions on what mes­sag­ing, if any, FDA lead­ers can em­ploy that would both sat­is­fy the pres­i­dent and the sci­en­tif­ic com­mu­ni­ty.

Trump be­gan Wednes­day’s press con­fer­ence by en­cour­ag­ing Amer­i­cans to en­roll in Covid-19 vac­cine tri­als, and then tout­ed some ques­tion­ably star­ry num­bers on treat­ments in the pipeline. “We are see­ing promis­ing re­sults that are mon­o­clon­al an­ti­bod­ies which help the im­mune sys­tem fight the virus,” Trump said, halt­ing­ly read­ing a script.

But the first ques­tion he took was on the peace­ful trans­fer of pow­er af­ter the elec­tion. He re­fused to com­mit to it.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.