Reshma Ramachandran

Now out in @NEJM is a piece from @jsross119, @berg_karina, & me on how @US_FDA's recent accelerated approval of #lecanemab highlights the agency's expanded use of the expedited review pathway & concerns this raises for patients, caregivers, & clinicians: nejm.org/doi/full/10.10…

Watching this panel, most of which have strong views about the use of SSRIs in pregnancy (& SSRIs overall) & remembering that there is no open public hearing, no public comment period, & no FDA scientists (just political appointees) is deeply troubling. gooznews.substack.com/p/opinion-masq…

Wondering if the FDA Commissioner consulted his own legal team before this @Bloomberg interview because between this misleading statement of FDA's authority & overhyping release of denial letters that were already (mostly) publicly available, it seems like he probably should?

Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market endpoints.news/sarepta-would-…

Maybe Elsa won't solve the 20% cut & add'l departures at FDA: "AI is supposed to save our time, but I guarantee you that I waste a lot of extra time just due to the heightened vigilance that I have to have" to check for fake or mispresented studies, a 2nd @US_FDA employee said.

CNN's @owermohle has a new report out today detailing how FDA's new Elsa AI tool is quite unrealiable, undercutting claims about how it will be used to make FDA more efficient: cnn.com/2025/07/23/pol…

SCOOP from @adamfeuerstein, @Jasonmmast: Sarepta’s Duchenne therapy faces an "arduous" path back to market, a senior FDA official says, suggesting the treatment’s license could be revoked statnews.com/2025/07/22/fda…

Very comprehensive summary of yesterday's FDA Expert Panel on the use of SSRIs in pregnancy by @AriaBendix @NBCNews and how several panelists raised doubts about SSRIs overall. Again, no FDA scientists presented nor is there a public comment option: nbcnews.com/health/mental-…

Reassuring to see @Sarepta walk back its initial refusal to @US_FDA's request to halt shipments of Elevidys after multiple patient deaths. In the interim, FDA can take stronger regulatory action & publicly release findings from its ongoing investigation. statnews.com/2025/07/21/sar…

How many patient deaths will it take for @US_FDA to withdraw the drug from the market, not just "request" the manufacturing stop selling the drug? Recall that the former CBER Director overruled his staff despite the trials failing to show clinical benefit? citizen.org/article/failed…

CRRIT Co-Director @reshmagar provided public comments at the Prescription Drug User Fee Act (PDUFA) VIII Kickoff Meeting @US_FDA yesterday. Dr. Ramachandran discussed how the user fee process could be reformed to be more patient-centered & transparent.

Surrogate markers are increasingly being used to support @US_FDA drug approvals instead of measuring clinical outcomes. In a new @scientistsorg memo, @reshmagar @JoshuaDWallach & @jsross119 outline how FDA can make transparent & strengthen their evidence. fas.org/publication/va…

If Makary is serious about drug-review transparency, publish CRLs when they're issued. That will be the true test. Disclosing old CRLs on drugs that were later approved doesn't tell you very much. Will it incentivize companies today to be more transparent and honest about…

The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusing attention on what’s often an opaque part of the drug review process. The agency only highlighted letters that went to drugmakers whose products were…

This is welcome news but will the @US_FDA post complete response letters (denial letters) for drugs and biologics that ultimately were not approved and subsequent denials occurring now? Why limit the release to only those approved? fda.gov/news-events/pr… #RadicalTransparency

In a new @nytmag piece, CRRIT Co-Directors, @reshmagar & @jsross119, discuss the consequences of rapid changes at the @US_FDA. (1/2) 🔗 nytimes.com/2025/07/08/mag…

Must-read story from @JInterlandi on Trump & RFK Jr's catastrophic assault on the FDA. I'm quoted briefly, echoing a warning @reshmagar, @drJoshS, & other watchdogs reiterated for years: FDA's unnecessary, excessive secrecy fueled conspiracy theories. 1/3