Reshma Ramachandran

Flexibility Over Rigor: Stakeholder Acceptance of the Limitations of Confirmatory Studies Following Accelerated Approval Despite the importance of postmarketing requirements (PMRs) following accelerated approval and well-recognized shortcomings in their rigor and timeliness,

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...

HHS employees demand RFK Jr. resign for ‘compromising the health of this nation’ | CNN More than 1,000 current and former employees of the US Department of Health and Human Services wrote a letter to Secretary Robert F. Kennedy Jr. on Wednesday, arguing that his leadership has “put the ...

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

Lee E. Teitelbaum Utah Law Review Symposium – Fireproofing the FDA: Power, Politics, and Public Health - S.J. Quinney College of Law

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)

Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials - PubMed Industry payments to physicians influence prescribing, raising concern for drugs granted accelerated approval that failed confirmatory studies. We measured industry payments for oncology drugs granted...

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/

Inside the research machine that helps UnitedHealth protect its Medicare profits A STAT Investigation: Inside the research machine that helps UnitedHealth protect its Medicare profits.

Really also makes you wonder what happened during the journal peer-review process that allowed publication of these funded studies with obvious flaws: "Wyatt Decker, UnitedHealth’s chief physician...said in a statement that its studies were rigorously examined by peer reviewers." #MedSky

Inside the research machine that helps UnitedHealth protect its Medicare profits A STAT Investigation: Inside the research machine that helps UnitedHealth protect its Medicare profits.

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...

Exclusion of Older Adults from Obesity Treatment Pivotal Trials of GLP-1RAs and GIP/GLP-1RAs - Journal of General Internal Medicine Journal of General Internal Medicine -

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...

After 'conflicting' signals from FDA, rare disease drugmaker contemplates closure Stealth BioTherapeutics, which has been developing a rare disease drug, said it is making contingency plans to close the company after getting "conflicting" signals from the FDA.

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...

Regulatory change could improve biosimilar access in the US Tiffany E Jiang , Reshma Ramachandran , and Joshua J Skydel argue that US requirements for interchangeability are not supported by evidence and hamper use of biosimilars Biological medicines (biologi...

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/...

One of the experts on this panel: "Another panelist, psychologist Roger McFillin — who hosts a podcast that challenges conventional mental health advice — suggested that depression wasn’t an illness but rather a product of 'women just naturally experiencing their emotions more intensely.'" #MedSky

FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say Nearly all of the 10 panelists emphasized what they said were risks of the drugs. Some claimed, without evidence, that antidepressants don't work at all.

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

What’s Value in Health Care? Powerful Companies Make It Hard To Know Powerful health care companies shape the informational environments around their products. As part of this playbook, companies avoid or thwart the generation and dissemination of accurate information…

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

The FDA commissioner is a gifted talker — but the job is about more than that FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the sake of an uncertain payoff.

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.

Inside the Collapse of the F.D.A.

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

Validating Surrogate Endpoints to Support FDA Drug Approval As surrogate markers are increasingly being accepted by FDA to support approval of new drugs and biologics, it is imperative that patients and clinicians understand whether such novel endpoints are re...

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/...

Efficacy And Safety Concerns Are Important Reasons Why The FDA Requires Multiple Reviews Before Approval Of New Drugs | Health Affairs Journal The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients’ access to new ...

Yes, this is overstated - you can look at approval packages and find these. Prior studies including by @jsross119.bsky.social have examined these. Ideally, would like to see denials - impt for understanding reg decision-making & informing other manufacturers. www.healthaffairs.org/doi/10.1377/...

@cmorten.bsky.social if I'm not mistaken has written about this and how this might be overstated and could be managed. Interestingly, Cavazzoni this January at the annual CERSI Summit indicated support for publishing them all including for those ultimately not approved.

FDA Embraces Radical Transparency by Publishing Complete Response Letters The FDA today published more than 200 decision letters, known as complete response letters (CRLs).

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.

Opinion | 55 years to fulfill a records request? Clearly, the FDA needs serious reform of its data-sharing practices. The FDA's glacial time frame for releasing documents on the Pfizer/BioNTech vaccine is only the latest evidence that the agency needs some major changes.

@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.

Judge vacates Trump administration's removal of health web pages A federal judge ruled that the swift takedown of health information across several government webpages earlier this year was illegal and vacated agencies’ directives to do so. | January's abrupt removals of public health webpages and datasets to comply with an executive order on gender and sex were a case of "government officials acting first and thinking later," a federal judge wrote in his ruling.

“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

Inside the Collapse of the F.D.A.

"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...

Inside the Collapse of the F.D.A.

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

Inside the staff exodus and tanking morale that threaten Makary’s FDA FDA staff are struggling and missing deadlines, and the future consequences could be even more dire.

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...

Win in Doctors for America Lawsuit Against Trump’s HHS - Public Citizen WASHINGTON, D.C. — Today, a federal judge ruled in favor of Doctors for America (DFA) and the City and County of San…

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...