Reshma Ramachandran
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reshmagar.bsky.social
Reshma Ramachandran
@reshmagar.bsky.social
1.1K followers 520 following 230 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 Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · 4d
First announced in June, these vouchers are meant to shorten drug review to 2 mos or less. Despite current FDA leadership claiming prior inappropriate industry influence, CRRIT Co-Director @reshmagar.bsky.social noted “cut to now, and it seems like the hen has let the fox into the henhouse.”

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · 4d
🔗 www.statnews.com/2025/12/19/f...
FDA voucher program has become vehicle for political interference in drug review decisions, staffers say
Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority review voucher program for drug companies.
www.statnews.com

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 6d
An important piece in @nytimes.com with critical context about why overhauling the US childhood vaccine schedule to match Denmark's is a very bad idea, especially as the White House & politicians continue to strip healthcare access for millions in this country. @drsforamerica.bsky.social #MedSky

Reposted by Reshma Ramachandran

mattherder.bsky.social
mattherder.bsky.social @mattherder.bsky.social · 7d
Classic yet alarming: the federal govt just posted in the Canada Gazette a proposal to fundamentally change drug regulation as we know it.

Here's the link to the Gazette: gazette.gc.ca/rp-pr/p1/202...
Canada Gazette, Part 1, Volume 159, Number 51: Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs
December 20, 2025, Part 1, Volume 159, Number 51, Canada Gazette
gazette.gc.ca

Reposted by Reshma Ramachandran

drsforamerica.bsky.social
Doctors for America @drsforamerica.bsky.social · 10d
Interview with Reshma Ramachandran on changes to the FDA’s adverse-event data releases and future directions for enhancing its safety-surveillance infrastructure. | New England Journal of Medicine

@reshmagar.bsky.social
www.nejm.org/do/10.1056/N...
Interview with Reshma Ramachandran on changes to the FDA’s adverse-event data releases and future directions for enhancing its safety-surveillance infrastructure. | NEJM
Audio Interview from the New England Journal of Medicine — Interview with Reshma Ramachandran on changes to the FDA’s adverse-event data releases and future directions for enhancing its safety-surveillance infrastructure.
www.nejm.org

Reposted by Reshma Ramachandran

sarahkarlin-smith.bsky.social
Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · 16d
If you are following the FDA's new commissioner's national voucher program this post from Paul Kim is a must read...

"No miracles here."

www.linkedin.com/feed/update/...
#fda #cpnv #publichealth #pdufa #kendallsquarepolicy | Paul T. Kim
Yesterday, #FDA announced its first approval under the Commissioner's National Priority Voucher (#CPNV) pilot – of a new domestic manufacturing line for a 23-year old drug. “The approval,” declared F...
www.linkedin.com

Reposted by Reshma Ramachandran

jsross119.bsky.social
Joseph Ross @jsross119.bsky.social · 18d
New paper from @yalecrrit.bsky.social out today in @jamainternalmed.com - The 2007 US Food and Drug Administration (FDA) Amendments Act (FDAAA) expanded the agency's safety-related regulatory authorities, including enhanced postmarketing safety surveillance and new clinical study requirements (1/5)

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 18d
As we state in our @nejm.org Perspective piece, if FDA is serious about patient safety, then adequate staffing, resources, & true transparency are critical in addition to prioritizing enhancing active safety surveillance, not just increased reporting of safety signals yet to be investigated. #MedSky

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 18d
for Duchenne muscular dystrophy based on data from FAERS and other sources, including a new black box warning, drug label changes, & withdrawal of an indication approval. However, the agency offered no real explanation of the evidence used in their press release announcement.
a woman is asking how did you get there
ALT: a woman is asking how did you get there
media.tenor.com

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 18d
When reports submitted to FAERS are investigated and used by FDA to take regulatory actions, the agency continues to be opaque about how this data and other sources led to safety actions. FDA recently took significant safety actions for #Elevidys... www.fda.gov/news-events/...
FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent sa...
www.fda.gov

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 18d
Previous FDA leadership have laid out these issues with VAERS nicely in their recent NEJM Perspective article: www.nejm.org/doi/full/10....

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · 18d
While our @nejm.org Perspective focuses on #FAERS (FDA's passive drug safety surveillance system), the limitations to this database also apply to VAERS for vaccines. Current FDA leadership is using VAERS to make conclusions despite its many limitations & no scientific explanation. #MedSky

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · 18d
Now out in @nejm.org is a new Perspective piece from the CRRIT team on the potential consequences of @fda.gov's recent announcement to release daily drug adverse event reports from FDA’s Adverse Event Reporting System (FAERS) www.nejm.org/doi/full/10.... (1/11)
Enhancing FDA Drug-Safety Surveillance — Beyond Releasing Daily Adverse-Event Data | NEJM
The FDA recently announced that it will be releasing daily drug adverse-event data. But questions remain about how it will manage frequent releases and how the public may interpret released informa...
www.nejm.org

Reposted by Reshma Ramachandran

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · 19d
Excited to work with @pzettler.bsky.social and @reshmagar.bsky.social on this new project supported by @arnoldventures.bsky.social with the goal of developing a principles-based approach to rebuilding and re-envisioning FDA.

moritzlaw.osu.edu/ohio-state-a...
Ohio State and Partners Secure Grant to Inform Future Vision of FDA
Researchers at The Ohio State University Moritz College of Law and partner universities were recently awarded a grant from Arnold Ventures to support a multi-faceted research project, titled “A Princi...
moritzlaw.osu.edu

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · 22d
What does this mean?
-In making a single pivotal clinical trial the default for drug approval, FDA is moving away from the administration’s stated “gold science standard” that calls for a quality minimum of “replicability” and “reproducibility.” (www.whitehouse.gov/presidential...)
Restoring Gold Standard Science
By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 7301 of title 5, United
www.whitehouse.gov

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · 22d
ICYMI: @lizzylawrence.bsky.social in @statnews.com News scooped that the @fda.gov is planning to require only a single pivotal clinical trial to be the basis of drug approval, rather than 2 or more.

Reposted by Reshma Ramachandran

sarahkarlin-smith.bsky.social
Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · Nov 24
The combination of diminished staff capacity and immense pressure to use new, but unvalidated, AI tools to replace it “could jeopardize FDA’s gold standard review process, leaving ... further uncertainty about whether FDA-approved drugs work and are effective." - @reshmagar.bsky.social
US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry
Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operatin...
insights.citeline.com

Reposted by Reshma Ramachandran

lizzylawrence.bsky.social
Lizzy Lawrence @lizzylawrence.bsky.social · Nov 21
NEW: FDA review staff was excluded from voting on whether to approve first priority voucher drug. Top leaders like Vinay Prasad, George Tidmarsh, and Tracy Høeg led the vote instead. Read for the full list, and expert reaction from @hollylynchez.bsky.social: www.statnews.com/2025/11/21/t...
FDA review staff was excluded from voting on whether to approve first priority voucher drug
Top officials like Vinay Prasad and George Tidmarsh voted on the drug, a major break from the FDA's typical practice.
www.statnews.com

Reposted by Reshma Ramachandran

yalecrrit.bsky.social
Yale CRRIT @yalecrrit.bsky.social · Nov 11
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 Juliet B. Schor, Valerie P. Hans, Anders Nilsson , and 2 more

sanders.senate.gov
Senator Bernie Sanders @sanders.senate.gov · Nov 10
Tonight was a very bad night.

reshmagar.bsky.social
Reshma Ramachandran @reshmagar.bsky.social · Nov 7
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 · Nov 7
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 · Nov 7
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 · Nov 7
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 · Nov 7
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 · Nov 7
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 · Nov 6
"what if MFN in Medicaid, but voluntary?"

Reposted by Reshma Ramachandran

hollylynchez.bsky.social
Holly Fernandez Lynch @hollylynchez.bsky.social · Oct 22
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 · Oct 20
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 · Oct 19
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