Reshma Ramachandran
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reshmagar.bsky.social
Reshma Ramachandran
@reshmagar.bsky.social
1.1K followers 520 following 220 posts

Assistant Professor, primary care physician, and health services researcher at Yale School of Medicine, Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT); *views expressed here are my own* .. more

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Economics 46%
Biology 19%
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Reposted by Juliet B. Schor, Valerie P. Hans, Anders Nilsson , and 2 more

sanders.senate.gov
Senator Bernie Sanders @sanders.senate.gov · 1d
Tonight was a very bad night.

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
These backroom deals between the administration and Big Pharma will not meaningfully lower drug prices for my patients, especially without health insurance or when their limited, fixed incomes are having to pay more to keep their insurance or for food for them and their families.

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
for pharma to opt into to provide drugs at "most-favored nation" prices to Medicaid patients when we're on the precipice of over 10 million losing this coverage. I said it last week before @sanders.senate.gov and Senate HELP and I'll say it again...

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
be kicked off their insurance or those who just can't pay for their health insurance anymore because of premium price hikes, having GLP-1s and a handful of other expensive drugs listed on TrumpRx for a price they still cannot pay just doesn't matter. Nor does a voluntary model...

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
We just cannot keep looking at our patients' health policy by policy - all of these are connected and the most vulnerable - the elderly, the poor, those living paycheck to check - are the ones who are and will be harmed the most. For my patients on Medicaid who are about to...

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
those who told me they're trying to figure out whether or not they could still afford their insurance after they got notices about the premium increases. Not to mention the many others who have expressed fear before about their Medicaid coverage being cut in the near future...

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 4d
Lots of thoughts regarding today's White House announcements on drug pricing policies for GLP-1s and the Medicaid drug pricing model. But clouding all of this are the 4 patients I saw today in clinic who asked me about food pantries due to their SNAP benefits being cut and... #MedSky

Reposted by Reshma Ramachandran

adrianna.bsky.social
Adrianna McIntyre @adrianna.bsky.social · 4d
"what if MFN in Medicaid, but voluntary?"

Reposted by Reshma Ramachandran

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · 19d
Here's how @reshmagar.bsky.social and I put the same sentiment in the LA Times this weekend: www.latimes.com/opinion/stor....
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.

Reposted by Reshma Ramachandran

sarahkarlin-smith.bsky.social
Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · 21d
Coupling existing regulatory flexibility with a faster review “is concerning because that just means that, not only will they lower the bar for what type of evidence will be required … but also on top of that they’re going to have reviewers be less careful ..." @reshmagar.bsky.social
First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher
Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds ...
insights.citeline.com

Reposted by Reshma Ramachandran, Dana Howard

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · 22d
In this am's @latimes.com, @reshmagar.bsky.social + I have an op-ed raising concerns abt pressure to approve rare disease drugs no matter how weak the evidence. Flexibility is reasonable but FDA approval must mean more than “this drug has not been shown not to work."
www.latimes.com/opinion/stor...
Contributor: By loosening standards, the FDA isn't doing rare-disease patients any favors
It’s reasonable to assess rare-disease drugs differently. That’s why the FDA has been remarkably flexible about these approvals for decades. But some treatments just aren't any good.
www.latimes.com

Reposted by Els Torreele, Reshma Ramachandran

mattherder.bsky.social
mattherder.bsky.social @mattherder.bsky.social · 26d
I'm hiring a Legal Research Fellow!

dal.peopleadmin.ca/postings/19632

CC @roojinhabibi.org @drximebena.bsky.social @elstorreele.bsky.social @cmorten.bsky.social @gregggonsalves.bsky.social @reshmagar.bsky.social @hollylynchez.bsky.social @akapczynski.bsky.social @fatimahassan.bsky.social
Research Fellow
Working in close collaboration with the Chair in Applied Public Health, the Infectious Disease Innovation Governance (IDIG) Research Fellow will play a leading role in a variety of research and capaci...
dal.peopleadmin.ca

Reposted by Daniel Aaron, Daniel S. Goldberg, Reshma Ramachandran , and 1 more

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · Oct 8
New from @pzettler.bsky.social @reshmagar.bsky.social + me in @jhppl.bsky.social.
We describe themes driving historic FDA reforms, explain how what's happening under Trump2 is different + call for principles to guide FDA reform and activity across administrations.
read.dukeupress.edu/jhppl/articl...

Reposted by Joseph S. Ross, Reshma Ramachandran

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · Sep 20
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

Reposted by Reshma Ramachandran

megtirrell.bsky.social
Meg Tirrell @megtirrell.bsky.social · Sep 3
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

Reposted by Reshma Ramachandran, Michael S. Sinha

medlawdan.bsky.social
Daniel G. Aaron, MD, JD @medlawdan.bsky.social · Aug 28
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

Reposted by Reshma Ramachandran

thewonkologist.bsky.social
Aaron Mitchell @thewonkologist.bsky.social · Aug 28
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

Reposted by Reshma Ramachandran, Jason L. Schwartz

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Aug 16
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)

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Aug 12
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

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Aug 12
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

Reposted by Reshma Ramachandran

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · Aug 6
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

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Aug 1
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

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Jul 30
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

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Jul 22
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

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Jul 22
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

Reposted by Els Torreele, Reshma Ramachandran

cmorten.bsky.social
Chris Morten @cmorten.bsky.social · Jul 22
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

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Jul 16
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

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Jul 15
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.

Reposted by Reshma Ramachandran

cspinet.org
Center for Science in the Public Interest @cspinet.org · Jul 11
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

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Jul 10
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