Post-market studies supporting recently approved FDA drugs are increasingly using non-randomized RWE approaches, note Louis Li and colleagues, though such approached remain infrequent in the pre-market setting. @JoshuaDWallach @yalesph.bsky.social @reshmagar.bsky.social @jsross119.bsky.social

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...

Diffusing authority to make drug approval decisions at the US Food and Drug Administration - Nature Medicine

The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making authority of individ...

nature.com

Helen Branswell 🇨🇦@helenbranswell.bsky.social · 6mo ago

BREAKING: @lizzylawrence.bsky.social reports that CBER director Vinay Prasad overruled career #FDA staff and unilaterally decided to refusal to accept #Moderna 's #flu vaccine submission. www.statnews.com/2026/02/11/m...

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...

Chris Morten@cmorten.bsky.social · 7mo ago

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. 1/

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...

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.

jamanetwork.com

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. 1/

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.”

🔗 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.

statnews.com

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

Apoorva Mandavilli@apoorvanyt.bsky.social · 8mo ago

RFK Jr. is expected to announce in the new year that American children should be immunized according to the schedule followed by Denmark — which is much smaller, mostly homogenous and has universal health care. (Free link) www.nytimes.com/2025/12/19/h...

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.

nejm.org

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...

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...

linkedin.com

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)

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

Yale CRRIT@yalecrrit.bsky.social · 8mo ago

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)

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

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

whitehouse.gov

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.

Lizzy Lawrence@lizzylawrence.bsky.social · 9mo ago

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...

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

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.

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

Adrianna McIntyre@adrianna.bsky.social · 9mo ago

"what if MFN in Medicaid, but voluntary?"

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

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.

latimes.com

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

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

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 ...

cnn.com

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

law.utah.edu