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:

Funny enough at the PDUFA kickoff, he said "I'm still learning what I'm allowed to say" right before claiming FDA is on track to approve 20% more new drugs. Seems unlikely with PDUFA deadlines being missed & only 19 approvals so far. He has expert staff he can confirm with. 🤦🏿‍♀️.

ICYMI: Great piece by @matthewherper in @statnews o how the FDA Commissioner too often hypes & misleads his plans that upon scrutiny, are just not much or not possible. Hoping after this 100 days of PR for more substance & real action at the agency.

RT @Yale_CRRIT: CRRIT Co-Director @reshmagar provided public comments at the Prescription Drug User Fee Act (PDUFA) VIII Kickoff Meeting @U….

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?

RT @Yale_CRRIT: Surrogate markers are increasingly being used to support @US_FDA drug approvals instead of measuring clinical outcomes. In….

RT @adamfeuerstein: If Makary is serious about drug-review transparency, publish CRLs when they're issued. That will be the true test. Di….

RT @adamfeuerstein: The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines, focusin….

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? #RadicalTransparency.

RT @Yale_CRRIT: In a new @nytmag piece, CRRIT Co-Directors, @reshmagar & @jsross119, discuss the consequences of rapid changes at the @US_F….

RT @cmorten2: Must-read story from @JInterlandi on Trump & RFK Jr's catastrophic assault on the FDA. I'm quoted briefly, echoing a warning….

RT @awgaffney: This is an excellent article that explains these issues, and the ongoing assault on the FDA, and the perspectives of people….

RT @LizzyLaw_: Exclusive: I spoke with 15 employees at the FDA to get a sense of how the agency is functioning since the April 1 layoffs. T….

Some good news with special thanks to @Public_Citizen representing @drsforamerica & San Francisco - a judge has ordered that crucial health information and websites be restored on federal health agency websites, vacating OPM's and HHS's unlawful policies:

RT @ktkadakia: Thanks @KatieMPalmer and @statnews for covering our new analysis of @US_FDA’s Breakthrough Devices Program. Are devices auth….

RT @ktkadakia: (1/12) New in @JAMAInternalMed: we assess the performance of @US_FDA's Breakthrough Devices Program across its first 8 years….

RT @ZacharyBrennan: Incredible reporting from @AndrewE_Dunn: FDA chief Makary sought rejection of KalVista's drug - in normal times this is….

Less than a month until applications are due for @NationalCSP:.2️⃣ years of protected time to learn health policy & health services research meant to create change for patients.💅🏿very easy application compared to any other fellowship!. @SocietyGIM @aafp.

RT @brittanytrang: Late last year, the FDA's AI medical device counter hit 1,000 authorized devices. And then . nothing. There haven't be….

RT @HelenBranswell: Steve Woloshin has for years taught journalists how to read and interpret scientific studies accurately. Ironic to see….

RT @Yale_CRRIT: The @US_FDA says it will “radically increase efficiency” with AI and embrace “radical transparency.” But as @reshmagar tol….