Here's our new article reporting findings from stakeholder interviews in which we hoped to learn what it takes to successfully complete rigorous confirmatory studies after accelerated approval. Instead, we mostly heard willingness to trade rigor for feasibility. 1/ academic.oup.com/healthaffair...

1,000+ HHS employees (current & former) call for RFK Jr’s resignation www.cnn.com/2025/09/03/h...

Thrilled to announce an upcoming symposium at Utah Law (@sjquinney.bsky.social): Fireproofing the FDA: Power, Politics, and Public Health Free to register and featuring @deankronkwarner.bsky.social @saragerke.bsky.social @ghorvath.bsky.social . . . www.law.utah.edu/event/lee-e-...

User fees have had a critical role in funding @fda.gov since 1992. In our new @nejm.org Perspective, we outline the history and intent of PDUFA, & suggest potential reforms to the PDUFA VIII negotiation process to enable transparency & promote patient-centeredness (1/3)

Cancer drugs with Accelerated Approval have to undergo confirmatory clinical trials. What happens when the confirmatory trial fails, showing no clinical benefit? Does the manufacturer stop promoting the drug to doctors? We took a look: pubmed.ncbi.nlm.nih.gov/40855611/ 1/

Great piece from @statnews.com @caseyross.bsky.social @bobjherman.bsky.social @tarabannow.bsky.social @lizzylawrence.bsky.social on how UnitedHealth has published misleading research on Medicare Advantage in peer-reviewed medical journals for its lobbying efforts: www.statnews.com/2025/08/11/u...

This team comprised of @yaleschoolofmed.bsky.social Alissa Chen, @keckschoolusc.bsky.social Yixuan Liang, @yaleschoolofmed.bsky.social Kasia Lipska, and CRRIT Co-Directors @jsross119.bsky.social and @reshmagar.bsky.social Full analysis: link.springer.com/article/10.1...

What should we infer from the fact that the company refuses to release its complete response letter while insisting that FDA is being unreasonable? I agree with @reshmagar.bsky.social: "I’m a little doubtful about the narrative." www.statnews.com/pharmalot/20...

In a recently published article in @bmj.com, @yaleschoolofmed.bsky.social student Tiffany Jiang, CRRIT Co-Director @reshmagar.bsky.social & Joshua Skydel (Yale Rheumatology) investigate how eliminating these requirements can increase access to biosimilars (2/2) 🔗 www.bmj.com/content/390/...

Very comprehensive and great summary of yesterday's FDA Expert Panel on SSRIs in pregnancy and how several panelists raised doubts about SSRIs overall. No FDA scientists presented nor is there a public comment opportunity. So much for #radicaltransparency. www.nbcnews.com/health/menta... #MedSky

New blog post from me in @lpeblog.bsky.social! Quick thread below! lpeproject.org/blog/whats-v... 1/

ICYMI: Great piece by @matthewherper.bsky.social in @statnews.com on how the new FDA Commissioner too often hypes and misleads about his plans for FDA that on further scrutiny are not much or not possible. Hoping for less PR and more substance moving forward. www.statnews.com/2025/07/14/f... #MedSky

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

After massive job cuts, FDA is in freefall. "You have to have a deep cynicism about what these workers are doing to believe that fewer of them is better,” says CSPI President @drpeterlurie.bsky.social. w/ @drjoshs.bsky.social, @jsross119.bsky.social‬, @reshmagar.bsky.social, @robcaliff.bsky.social

Surrogate markers are increasingly being used to support @fda.gov approvals instead of measuring clinical outcomes. In a @scientistsorg.bsky.social memo @reshmagar.bsky.social, Joshua Wallach & @jsross119.bsky.social outline how FDA can make transparent & strengthen evidence. fas.org/publication/...

This is welcome news but will the @fda.gov 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? www.fda.gov/news-events/... #MedSky

RFK Jr. has used the FDA's unnecessary secrecy as a PR cudgel, painting a lifesaving agency full of dedicated, expert public servants as hopelessly captured & corrupt. This is a dark time. My clinic & clients, including @drsforamerica.bsky.social, remain committed to protecting FDA's essential work.

@reshmagar.bsky.social, @jsross119.bsky.social & @akapczynski.bsky.social & I wrote in 2021 that "Reforming [FDA's] data-sharing practices is essential to combating future vaccine misinformation and preventing public mistrust of the FDA from festering further." www.washingtonpost.com/opinions/202...

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

“It is heartening to see that the court agrees with doctors, researchers, and patients that the government cannot unlawfully and without explanation remove crucial health information and datasets." @reshmagar.bsky.social www.fiercehealthcare...

“The F.D.A. meets with industry hundreds of times over the user-fee renewals, and only half a dozen or so times with the rest of us. Whether it’s conscious or deliberate or not, what you see over time is that industry’s priorities become agency priorities.” @reshmagar.bsky.social

"Approving drugs quickly and with less evidence might give doctors and patients more options, but it also shifted a huge burden of uncertainty from the agency onto them." @reshmagar.bsky.social www.nytimes.com/2025/07/08/m...

Honored to have @yalecrrit.bsky.social's work featured in this excellent @nytimes.com Mag piece on the ongoing assault and decimation of @fda.gov. There is no doubt the agency is imperfect but taking a sledgehammer to our national regulator is not the way. www.nytimes.com/2025/07/08/m... #MedSky

Must-read piece by @lizzylawrence.bsky.social in @statnews.com on impacts of @fda.gov changes: "The agency has missed a handful of review target dates and conducting inspections in foreign countries is challenging with the loss of administrative staff..." #MedSky www.statnews.com/2025/07/07/f...

Some good news with special thanks to @publiccitizen.bsky.social representing @drsforamerica.bsky.social & SF - a judge has ordered that health information & data be restored on federal health agency websites, vacating OPM's & HHS's unlawful policies. www.citizen.org/news/win-in-... #MedSky #EpiSky

The Senate reconciliation bill would reduce federal #Medicaid spending by $1 trillion over 10 years. Provisions that only apply to ACA expansion states account for $526 billion of the federal spending reductions. NEW @kff.org analysis looks at the impact across states: www.kff.org/medicaid/iss...

www.nytimes.com/interactive/... My latest in the New York Times. An attempt to warn the public that their health is about to get much worse.

“The commissioner is forcing the FDA to use its limited resources to rush through reviews of new drugs for unclear reasons. Corners are likely to be cut.” @reshmagar.bsky.social www.pharmavoice.com/news/fda-dru...

At @aspenideas.bsky.social Health where the CMS Deputy Administrator and Chief of Staff is claiming that CBO estimates that the reconciliation bill will cause millions will lose coverage are wrong. She does not have an estimate of her own. 🤯🤯🤯 #aspenhealth #MedSky

The @fda.gov says it will “radically increase efficiency” with AI and embrace “radical transparency.” But as @reshmagar.bsky.social told @nytimes.com, agency officials recently kicked off a six-city listening tour—with Pharma CEOs—behind closed doors. Here’s the scoop:

Looking forward to joining other health leaders at @aspenideas.bsky.social Health next week as part of their 2025 cohort of Fellows! #aspenideas #aspenideashealth Learn more: www.aspenideas.org/articles/202... Many thanks to @arnoldventures.bsky.social for this opportunity! #MedSky

With the same person in the role of FDA Center for Biologics Evaluation and Research, Chief Medical Officer, & Chief Scientific Officer, here's how the Scientific Dispute Resolution process at the agency will now look like. #MedSky

vinay prasad now not only cber head but fda cmo and chief scientific officer per email to fda staff.

Our special issue, “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” is now live in @jlme-journal.bsky.social. Check out the full line up of leading voices on spotting, addressing, and preventing misconduct. www.cambridge.org/core/journal...

“Only a movement will get us to a better future.” Dr. Reshma Ramachandran accepts the 2025 Bernard Lown Award @reshmagar.bsky.social lowninstitute.org/only-a-movem...

Thank you @by-cjewett.bsky.social @nytimes.com for chatting with me about this piece and my concerns that the priorities outlined by our national regulator read like PhRMA's own FDA playbook 👇 in calling for speedier reviews & less evidentiary rigor. www.nytimes.com/2025/06/10/h... #MedSky

Explore this gift article from The New York Times. You can read it for free: www.nytimes.com/2025/06/10/h... @drsforamerica.bsky.social 's @reshmagar.bsky.social quoted in today's NYT on the contradiction between what is being said about Pharma by Kennedy, and the intimate "listening tour" of Pharma

Skip the WSJ op-ed & read this from @pzettler.bsky.social, Steve Cha, Sarah Despres & @cspinet.org's Peter Lurie in @jama.com: "Political interference, or even the perception of political interference, in the FDA’s approval decisions could undercut public confidence." jamanetwork.com/journals/jam...

A political ideologue known for spreading vaccine misinformation firing all CDC expert advisors tasked to review scientific evidence to make informed recommendations on vaccines is the opposite of what HHS should do to restore public trust in vaccines: www.statnews.com/2025/06/09/r... #MedSky

Ok folks, we know work requirements reduce benefits without increasing work (cc: @chloeneast.bsky.social) But who loses benefits and what happens if work requirements are reversed? New evidence from linked SNAP-Medicaid data and a natural experiment in CT tell a concerning story... Thread below 👇

Tomorrow (Tues, June 10) at 10AM ET, NIH Director Jay Bhattacharya will be testifying before the Senate Appropriations Committee on the NIH budget. 1/

Truly honored to receive the Bernard Lown Award for Social Responsibility from the @lowninstitute.org. Dr. Lown's persistence & ability to mobilize the public against injustice are lessons I will carry forward as we continue to fight for a health system centered around our patients. Thank you 🙏🏿

Last Friday, the FDA very quietly announced they'd be hosting "CEO forums" - Here, they'll meet with pharmaceutical and biotechnology company CEOs and ask them to provide direct input in how the agency regulates new drugs. All behind closed doors. @reshmagar.bsky.social youtube.com/shorts/cnhZX...

Meet the winner of the 2025 Bernard Lown Award for Social Responsibility: @reshmagar.bsky.social! Learn more about her exceptional work championing fair access to medicines and advocating for health policy that prioritizes the public’s health over private profit. lowninstitute.org/dr-reshma-ra...

Senator @durbin.senate.gov asks the necessary questions of @fda.gov after the mass layoffs, if the agency has capacity to regulate drug ads and to provide numbers of who exactly is within the Office of Prescription Drug Promotion to do this necessary work. www.statnews.com/pharmalot/20... #MedSky

FDA is supposed to be an independent regulator. Last week, the FDA Commissioner wrote in @nejm.org that he recommends COVID-19 vaccines for pregnant people. Now, he stands besides the HHS Secretary as he announces that the COVID-19 vaccine will not be recommended for healthy pregnant people. #MedSky

New working paper on Medicaid, based on Medicaid expansions, finds: *Medicaid reduced mortality hazard for new enrollees by 21% *expansions were cost-effective *lack of health insurance explains about 5-20% of the mortality disparity between high- & low-income Americans www.nber.org/papers/w33719

FDA is set to restrict access to Covid shots for healthy people 6 months-64. I asked HHS if initial shots will be available to infants; no answer. One former CVS executive thinks healthy ineligible people who want a shot will face new costs. w / @maggieastor.bsky.social GIFT:

Donald Trump hosted a gala for the top 220 people that bought his meme coin. Buyers got special access to the President in exchange for lining his personal pockets. We protested this corruption and showed that America is NOT for sale.

Grim how we are discussing relative catastrophic cuts to health - and the cuts are catastrophic - but in absolute terms, health spending was already unacceptably low. WHO's budget shortfall = 8 hours of military spending. From Tedros's speech to the WHA this week: www.who.int/news-room/sp...