Despite an unproven link between the use of Tylenol during pregnancy and autism, the @fda.gov has initiated a label change process for acetaminophen products. It is expected that the manufacturer, Kenvue Inc, will challenge this as they stated there is no proven link. (1/3)

A significant number of companies have created large businesses selling GLP-1 compounded products. The @fda.gov recently sent 50 warning letters to these companies regarding false and misleading claims about compounded drugs (1/4)

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...

For decades @fda.gov has convened advisory committees of outside experts to discuss and vote on individual drug applications FDA CDER Director recently indicated that FDA intends to move away from these drug-specific advisory committees (1/3)

We are excited to share a recently published article in @ Journal of the National Cancer Institute which measured industry payments for oncology drugs that received accelerated approval before and after negative confirmatory trial findings (1/4)

We are excited to share a recently published study in @jamahealthforum.com , determining whether the lack of clinical validation and publicly traded company status were associated with recalls of AI-enabled medical devices (AIMDs). (1/4)

User fees have had a critical role in funding the @fda.gov since the enactment of PDUFA. A new RAPS article quoted our recent @nejm.org perspective “Reforming the Prescription Drug User Fee Program” (1/2)

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)

An increasing number of cancer drugs and gene therapies are receiving accelerated approval from @fda.gov. However, increased use of accelerated approval pathways raises concerns surrounding safety, efficacy, and clinical benefit (1/3)

ICMYI: AI/ML-enabled medical devices have potential for earlier diagnosis & symptom monitoring for Alzheimer’s disease & other dementias. A new @jama.com current study led by @hopkinsmedicine.bsky.social student Krista Chen looks at demographic representativeness of these devices (1/4)

Many older adults have obesity, yet few were included in clinical trials for GLP1s. Study exclusion criteria (depression, prior cancer) may contribute to the under-enrollment of adults ≥ 65 years (1/2)

Biosimilars provide low-cost options for patients and expanded access to treatment, but use of these treatments is hampered by @fda.gov requirements for interchangeability (1/2)

Many clinicians do not recommend compounded GLP-1RAs and are uninformed when patients seek these medications, which can leave patients vulnerable to misinformation. (1/2)

High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.

ICYMI: @fda.gov released a limited set of denial letters for drugs that were ultimately approved. CRRIT Co-Director @jsross119.bsky.social recently told @nytimes.com why these letters are important (1/2) 🔗 www.nytimes.com/2025/07/10/h...

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.

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/...

The @fda.gov says it will “radically increase efficiency” with AI and embrace “radical transparency.” But as @reshmagar.bsky.social told @nytimes.com, agency officials recently kicked off a six-city listening tour—with Pharma CEOs—behind closed doors. Here’s the scoop:

Do companies continue promoting drugs granted @fda.gov accelerated approval even after failed confirmatory trials? Yes—though less aggressively, finds Dr. Maryam Mooghali’s #ASCO25 Merit Award-winning research. 🔗 meetings.asco.org/abstracts-pr...

For patients with rare diseases, high-quality health info can be scarce. Research led by CRRIT post-doc Mengyuan Fu, PhD, on @nordrare.bsky.social’s free online disease reports found that 50% of sources cited were unavailable online or behind paywalls (~$168 per report). But... 🧵

Congrats to Reshma Ramachandran MD, MPP, MHS (Yale NCSP '20–'22), winner of the 2025 Bernard Lown Award for Social Responsibility! 👏 A powerful voice for health equity. Learn More: bit.ly/reshma-lown2025 #HealthEquity #SocialResponsibility #YaleNCSP #PharmaReform #[email protected]

So proud of our CRRIT @yaleschoolofmed.bsky.social students & @ncspyale.bsky.social fellows for presenting their research projects on the evidence underlying @fda.gov approvals, FDA safety actions, costs of care, drug pricing, & more at #SGIM25! @jsross119.bsky.social @reshmagar.bsky.social #MedSky

In March, a Texas judge tied @fda.gov’s hands on its ability to regulate lab-developed tests—to prevent, for example, another Theranos. In @statnews.com, CRRIT’s @ktkadakia.bsky.social, @jsross119.bsky.social, & @reshmagar.bsky.social explain the dangers of this ruling:

Our co-Director's research & policy work was featured by @yaleschoolofmed.bsky.social including what led to her & @jsross119.bsky.social re-establishing CRRIT which brings together expertise across campus to study how drugs, devices, etc are regulated & how that can be improved for patients. #MedSky

More than half of high-risk therapeutic medical devices approved by @fda.gov in recent years relied on trials with nonconcurrent control groups, according to our new @jama.com NetworkOpen study led by Dr. Maryam Mooghali:

Patients are losing access to unregulated, compounded GLP-1 drugs that cost less than Wegovy/Zepbound. It’s a “lose-lose situation,” said CRRIT co-director Dr. Reshma Ramachandran (@reshmagar.bsky.social) in @statnews.com. Read the full story:

DOGE’s cleaving of @fda.gov has left critical drug databases in disrepair, say current staff. As @reshmagar.bsky.social notes, these systems deliver real-time updates on drug safety & manufacturing—vital for clinicians, patients, payers, & research groups like ours. 📉

In the @us.theconversation.com, CRRIT co-director @reshmagar.bsky.social explains how mass layoffs at HHS run counter to “radical transparency,” with teams of public records staff responsible for transparency among those fired. Read below:

Latest in @jama.com Network Open: Medicare's Coverage with Evidence Development (CED) program has commissioned 116 clinical studies on medical devices and therapies, nearly half (49%) of which have results, producing 556 unique research publications. jamanetwork.com/journals/jam...

New article in @jlme-journal.bsky.social A thematic analysis on advisory committee meetings for @fda.gov-approved drugs that were considered for new indications, but ultimately not approved. Reasons for non-approval fell into two major themes. Thread 🧵⬇️

After another frenzied week at HHS, it’s hard to tell what will be left once the dust settles. “Guaranteed Pandemonium” reads the title of a @jama.com Medical News piece on the thoughts of public health leaders, including CRRIT’s co-director @reshmagar.bsky.social.

Check out our public comment submitted to @fda.gov on the accelerated approval pathway that clarifies how FDA can balance faster drug approval with ensuring sponsors confirm clinical benefit afterward – and if not, withdrawing products in a timely manner: www.regulations.gov/comment/FDA-...

New in @bmj.com: Analysis of 4.4 million+ medical device adverse event reports to @fda.gov reveals that 1+ million were reported late—often by 6+ months, and largely by a handful of manufacturers. What does this mean for patient safety? Thread (1/6) 🔽 www.bmj.com/content/388/...

In January, @fda.gov released a draft guidance clarifying a new policy that confirmatory trial(s) must be “underway” before the agency grants accelerated approval. Our public comment below applauds the policy & offers recommendations on trial timeliness & rigor: www.regulations.gov/comment/FDA-...

CRRIT is also disappointed that the Departments of Justice & Health and Human Services settled their HIV PrEP patent litigation with Gilead, abandoning efforts to ensure that the public gets a fair return on the tax dollars invested into developing the revolutionary therapy.

In @nejm.org, co-Director @jsross119.bsky.social discusses the CMS Innovation Center's pilot payment model for gene therapies, which would enable Medicaid beneficiaries access to the costly treatments, noting details the agency needs to get right: www.nejm.org/doi/full/10....

Our latest paper in JAMA Health Forum, led by @ashwinkchetty.bsky.social, examines how compounding pharmacies advertise their GLP-1 drugs (i.e., Ozempic, Wegovy) online. Half the websites did not report adverse effects and safety warnings. More below. 🧵 (Post 1/9) jamanetwork.com/journals/jam...

In its latest draft guidance on the Accelerated Approval pathway, FDA details how it will ensure that confirmatory trials are “underway” before approval. @reshmagar.bsky.social talks with @medcentral.bsky.social about ways to further clarify the draft: www.medcentral.com/biz-policy/d...

This week, @statnews.com spoke with our co-director, Reshma Ramachandran (@reshmagar.bsky.social), about a new HHS report critiquing parts of the @fda.gov's Accelerated Approval program: www.statnews.com/2025/01/14/o...

It isn’t always clear whether a new drug or device is effective. When in doubt, Medicare can insure a product for further study, called Coverage with Evidence Development (CED). In @HealthAffairs, we examine the evidence CMS uses for final CED decisions: www.healthaffairs.org/doi/full/10....

An RFK Jr. led Department of Health and Human Services (HHS), like any agency post-Chevron, would see its regulations challenged in courts. Can RFK Jr.'s agenda withstand the lawsuits? @reshmagar.bsky.social, Yale CRRIT Co-Director, comments in @huffpost.com: www.huffpost.com/entry/rfk-jr...

FDA oncology center officials recently outlined a framework to uphold accelerated approvals (AA) that fail confirmatory trials. In Oncology News Central, CRRIT co-Director @reshmagar.bsky.social questions whether obscure exceptions undermine the AA program.

🚨 Fresh insights on #HealthAndVeritas! We’re joined by @AKesselheim (@BrighamWomens, @HarvardMed) to discuss FDA reforms, Medicare coverage for obesity drugs, & the power of standing for integrity in health policy. Listen now: https://buff.ly/4f4MjsY @thehowie #HealthPolicy #FDAReform @thehowie

In Health Affairs, we analyzed the availability and quality of recent Medicare Local Coverage Determination summaries. Since 2019, the program has dramatically improved its public summary reporting. But the quality of evidence they cite within is...lackluster. www.healthaffairs.org/doi/full/10....