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Reshma Ramachandran

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H-index: 16
Economics 46%
Biology 19%
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Reposted by: Reshma Ramachandran, Joseph S. Ross

hollylynchez.bsky.social
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...
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,
academic.oup.com
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Reposted by: Reshma Ramachandran

megtirrell.bsky.social
1,000+ HHS employees (current & former) call for RFK Jr’s resignation www.cnn.com/2025/09/03/h...
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 ...
www.cnn.com
2 7 25

by Daniel Aaron — Reposted by: Reshma Ramachandran, Michael S. Sinha, Daniel Aaron

medlawdan.bsky.social
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-...
Lee E. Teitelbaum Utah Law Review Symposium – Fireproofing the FDA: Power, Politics, and Public Health - S.J. Quinney College of Law
www.law.utah.edu
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Reposted by: Reshma Ramachandran

thewonkologist.bsky.social
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/
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...
pubmed.ncbi.nlm.nih.gov
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Reposted by: Reshma Ramachandran, Jason L. Schwartz

yalecrrit.bsky.social
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)
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by Reshma Ramachandran

reshmagar.bsky.social
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.
www.statnews.com

by Reshma Ramachandran

reshmagar.bsky.social
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...
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.
www.statnews.com
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Reposted by: Reshma Ramachandran

hollylynchez.bsky.social
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...
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.
www.statnews.com
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Reposted by: Reshma Ramachandran

yalecrrit.bsky.social
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...
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 -
link.springer.com
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Reposted by: Reshma Ramachandran

yalecrrit.bsky.social
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/...
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...
www.bmj.com
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by Reshma Ramachandran

reshmagar.bsky.social
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

by Reshma Ramachandran

reshmagar.bsky.social
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
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.
www.nbcnews.com
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Reposted by: Reshma Ramachandran, Els Torreele

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

reshmagar.bsky.social
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
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.
www.statnews.com
6 3

Reposted by: Reshma Ramachandran

yalecrrit.bsky.social
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.
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Reposted by: Reshma Ramachandran

cspinet.org
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
Inside the Collapse of the F.D.A.
www.nytimes.com
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Reposted by: Reshma Ramachandran

yalecrrit.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/...
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...
fas.org
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by Reshma Ramachandran

reshmagar.bsky.social
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/...
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 ...
www.healthaffairs.org
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by Reshma Ramachandran

reshmagar.bsky.social
@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.
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by Reshma Ramachandran

reshmagar.bsky.social
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
FDA Embraces Radical Transparency by Publishing Complete Response Letters
The FDA today published more than 200 decision letters, known as complete response letters (CRLs).
www.fda.gov
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Reposted by: Reshma Ramachandran

cmorten.bsky.social
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.
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Reposted by: Reshma Ramachandran

cmorten.bsky.social
@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...
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.
www.washingtonpost.com
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by Reshma Ramachandran — Reposted by: Reshma Ramachandran

reshmagar.bsky.social
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 Collapse of the F.D.A.
www.nytimes.com
3 7

Reposted by: Reshma Ramachandran

drsforamerica.bsky.social
“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...
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.
www.fiercehealthcare.com
11 14

Reposted by: Reshma Ramachandran

drsforamerica.bsky.social
“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
2 7

Reposted by: Reshma Ramachandran

drsforamerica.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...
Inside the Collapse of the F.D.A.
www.nytimes.com
6 27 66

by Reshma Ramachandran

reshmagar.bsky.social
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...
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.
www.statnews.com
4 6

by Reshma Ramachandran

reshmagar.bsky.social
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
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…
www.citizen.org
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Reposted by: Reshma Ramachandran

liz-williams.bsky.social
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...
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Reposted by: Reshma Ramachandran

drsforamerica.bsky.social
“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...
FDA’s new mission to speed drug reviews
FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more streamlined.
www.pharmavoice.com
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