Reshma Ramachandran
@reshmagar.bsky.social
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*
Reposted by Reshma Ramachandran
We’re excited to share a recently published article in @jamainternalmed.com, led by Emory Medical School student Ravi Dhawan investigating venture capital (VC) investing trends by academic medical centers (AMCs). (1/7)
November 11, 2025 at 5:25 PM
We’re excited to share a recently published article in @jamainternalmed.com, led by Emory Medical School student Ravi Dhawan investigating venture capital (VC) investing trends by academic medical centers (AMCs). (1/7)
Reposted by Reshma Ramachandran
Tonight was a very bad night.
November 10, 2025 at 3:09 AM
Tonight was a very bad night.
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
November 7, 2025 at 3:12 AM
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
There are a lot of very interesting design choices in this model. A brief thread. 1/4
November 6, 2025 at 10:34 PM
There are a lot of very interesting design choices in this model. A brief thread. 1/4
Reposted by Reshma Ramachandran
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.
But that's one difficulty with this FDA, a disconnect between what they say and what they seem willing to do.
October 22, 2025 at 1:06 PM
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.
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
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...
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...
October 8, 2025 at 3:16 PM
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...
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 Reshma Ramachandran
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
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
October 15, 2025 at 2:04 PM
Reposted by Reshma Ramachandran
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...
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
October 19, 2025 at 11:29 AM
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...
www.latimes.com/opinion/stor...
Reposted by Reshma Ramachandran
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
October 20, 2025 at 1:16 PM
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
Reposted by Reshma Ramachandran
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...
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
September 20, 2025 at 12:14 PM
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...
academic.oup.com/healthaffair...
Reposted by Reshma Ramachandran
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
September 3, 2025 at 10:53 AM
1,000+ HHS employees (current & former) call for RFK Jr’s resignation www.cnn.com/2025/09/03/h...
Reposted by Reshma Ramachandran
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-...
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
August 28, 2025 at 8:36 PM
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-...
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-...
Reposted by Reshma Ramachandran
Reposted by Reshma Ramachandran
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/
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
August 28, 2025 at 1:13 AM
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/
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...
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
August 12, 2025 at 2:32 PM
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...
Reposted by Reshma Ramachandran
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...
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
August 1, 2025 at 2:20 PM
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...
Full analysis: link.springer.com/article/10.1...
Reposted by Reshma Ramachandran
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...
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
August 6, 2025 at 3:29 PM
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...
I agree with @reshmagar.bsky.social: "I’m a little doubtful about the narrative."
www.statnews.com/pharmalot/20...
Reposted by Reshma Ramachandran
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/...
🔗 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
July 30, 2025 at 2:48 PM
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/...
🔗 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
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
July 22, 2025 at 5:00 PM
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
Reposted by Reshma Ramachandran
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
July 16, 2025 at 9:55 AM
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
Reposted by Reshma Ramachandran
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.
July 15, 2025 at 2:10 PM
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
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
"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
July 11, 2025 at 4:03 PM
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
"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
Reposted by Reshma Ramachandran
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
July 10, 2025 at 9:10 PM
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
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
July 10, 2025 at 2:57 PM
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