Reshma Ramachandran

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)

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

a woman is asking how did you get there ALT: a woman is asking how did you get there

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.

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...

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/...

Previous FDA leadership have laid out these issues with VAERS nicely in their recent NEJM Perspective article: www.nejm.org/doi/full/10....

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

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...

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...

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

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...)

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.

When @reshmagar.bsky.social + I called for FDA to diffuse authority for drug approval decisions, this is NOT what we meant.

Approval decisions should be made by those closest to the data regarding safety and effectiveness, with every possible effort to avoid real or perceived political influence.

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...

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

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)

Tonight was a very bad night.

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.

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...

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...

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...

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...

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

There are a lot of very interesting design choices in this model. A brief thread. 1/4

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.

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...

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

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.

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...

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 ...

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

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/
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