Another instance of a center director acting unilaterally to overrule other staff (which here also involved ignoring FDA's previous statements to the company).

As @reshmagar.bsky.social and I have argued, the bar should be much higher for such unilateral action:
www.nature.com/articles/s41...

See @cmorten.bsky.social's extensive thread on the hearing including a link to he and @reshmagar.bsky.social's new editorial "Politics, Science, and the Future of FDA Drug Regulation: FDA’s Review of Mifepristone REMS as a Litmus Test."

bsky.app/profile/cmor...

Postmarket Safety Actions for Novel Oncology Drugs Granted Accelerated Approval This cross-sectional study examines postmarket safety actions for novel oncology drugs that received accelerated Food and Drug Administration (FDA) approval.

New study in @jamanetworkopen.com this week: frequency of post-market safety issues for cancer drugs with accelerated approval.

Happy to collaborate on this study with Dr. Mooghali, @reshmagar.bsky.social @jsross119.bsky.social

jamanetwork.com/journals/jam...

On Wed, Senate HELP will hold a hearing on "Protecting Women: Exposing the Dangers of Chemical Abortion Drugs"—pushing the lie that FDA's regulation has been lax. @reshmagar.bsky.social & I are in @jama.com today, on how FDA has, in fact, been (over-)careful in regulating medication abortion.
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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.”

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/2025/12/19/f...

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

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.

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...

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...

#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...

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/...

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