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.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.