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Yale CRRIT

@yalecrrit.bsky.social

770 followers 95 following 130 posts

The Collaboration for Regulatory Rigor, Integrity, & Transparency (CRRIT), based out of Yale Medical, Public Health, & Law schools, researches the regulation, approval, & coverage of medical drugs & devices to advance policies that improve patient health.

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Yale CRRIT @yalecrrit.bsky.social · 22h

Link to @jamainternalmed.com: jamanetwork.com/journals/jam...

More coverage of our work on @medpagetoday.com: www.medpagetoday.com/publichealth...

(3/3)

State Policies and Facility Practices of IV Hydration Spas in the US

This mixed-methods study examines variation in US state-level policies regarding the oversight and regulation of intravenous hydration spas as well as their product offerings, claims, and practices.

jamanetwork.com

Yale CRRIT @yalecrrit.bsky.social · 22h

@fda.gov doesn't regulation the industry; we found few states had oversight policies with wide variation in practices & promotion of products without clear benefits but with potential risks (2/3)

Full story: www.nbcnews.com/health/healt...

Hydration spas are largely unregulated, study finds

The first comprehensive research on the growing IV hydration industry finds little oversight of invasive procedures like vitamin drips.

www.nbcnews.com

Yale CRRIT @yalecrrit.bsky.social · 22h

Great news segment by @nbcnews.com of our CRRIT/
@yaleschoolofmed.bsky.social/@yalesom.bsky.social/ @cspinet.org study examining IV hydration spa regulation & practices (1/3)

Yale CRRIT @yalecrrit.bsky.social · 1d

We are excited to share a recently published study in @jamainternalmed.com which investigates state-level policies related to intravenous (IV) hydration spa regulation. Information regarding the safety of IV spas is limited (1/5)

Yale CRRIT @yalecrrit.bsky.social · 1d

Full article: jamanetwork.com/journals/jam... (5/5)

State Policies and Facility Practices of IV Hydration Spas in the US

This mixed-methods study examines variation in US state-level policies regarding the oversight and regulation of intravenous hydration spas as well as their product offerings, claims, and practices.

jamanetwork.com

Yale CRRIT @yalecrrit.bsky.social · 1d

This team was comprised of Massachusetts General Hospital & @yaleschoolofmed.bsky.social Anishaa Sivakumar, @yaleschoolofmed.bsky.social & @yalesom.bsky.social @thehowie.bsky.social, @cspinet.org @drpeterlurie.bsky.social & CRRIT Co-Director @jsross119.bsky.social (4/5)

Yale CRRIT @yalecrrit.bsky.social · 1d

Of the 255 facility websites reviewed, there was variation in spa practices (product offerings, product claims & staffing). In a secret shopper study, 86.2% of websites recommended specific products for proffered headaches and cold symptoms (3/5)

Yale CRRIT @yalecrrit.bsky.social · 1d

Key results: 32 states have issued guidance, but only 4 states addressed governance, prescriber credentials, dispensing practices, and compounding practices (2/5)

Yale CRRIT @yalecrrit.bsky.social · 1d

We are excited to share a recently published study in @jamainternalmed.com which investigates state-level policies related to intravenous (IV) hydration spa regulation. Information regarding the safety of IV spas is limited (1/5)

Yale CRRIT @yalecrrit.bsky.social · 7d

The article was led by @pennmedicine.bsky.social Caleb Rhodes working with CRRIT Co-Director @reshmagar.bsky.social, and @pennmehp.bsky.social @hollylynchez.bsky.social (3/3)

Full article: rdcu.be/eIEN7

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...

Yale CRRIT @yalecrrit.bsky.social · 7d

In the piece, the authors proposed alternatives to having decisions made by single FDA officials that run counter to multiple review teams as had occurred with Elevidys as well as more recently, broader access to COVID-19 vaccines. (2/3)

Yale CRRIT @yalecrrit.bsky.social · 7d

We are excited to share a recently published article in @nature.com Medicine, which investigates the decision-making process of individual officials when disagreements occur @fda.gov over drug approvals & ways to increase transparency (1/3)

Yale CRRIT @yalecrrit.bsky.social · 11d

Dr. Ramachandran said, “This is backwards. They’re announcing this process for making this change, and then they have the president and secretary go on national television and warn people to not take Tylenol.” (3/3)

🔗 news.bloomberglaw.com/health-law-a...

Trump Tylenol Warning Kicks Off Label Change Drugmaker May Fight

Details of the FDA’s plan to modify Tylenol’s label to say it may be associated with a risk of autism in children will be crucial in determining when and how the painkiller’s manufacturer can dispute ...

news.bloomberglaw.com

Yale CRRIT @yalecrrit.bsky.social · 11d

The FDA acknowledged there is no causal relationship & there is conflicting evidence in scientific literature. CRRIT Co-Director @reshmagar.bsky.social recently told @bloomberglaw.com that the FDA typically does not announce a process for a label change. (2/3)

Yale CRRIT @yalecrrit.bsky.social · 11d

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)

Yale CRRIT @yalecrrit.bsky.social · 13d

Dr. Ramachandran said while “it is good that the FDA is doing this”, it is unclear if the letters will lead to impactful change in companies’ marketing for the compounded products or for patients (4/4)

Full story: www.statnews.com/2025/09/19/f...

FDA takes on GLP-1 compounding boom with warnings about misleading marketing

In nearly 60 warning letters, the FDA took telehealth companies and other providers to task for false and misleading claims about compounded drugs the market.

www.statnews.com

Yale CRRIT @yalecrrit.bsky.social · 13d

CRRIT Co-Director @reshmagar.bsky.social told @statnews.com that one company cited by the FDA “put this response in that says, ‘It’s the same as the active ingredient in these brand name medications, and it’s more cost-effective.’” (3/4)

Yale CRRIT @yalecrrit.bsky.social · 13d

The letters target claims that compounded products are the same as FDA approved products. (2/4)

Yale CRRIT @yalecrrit.bsky.social · 13d

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)

Reposted by Yale CRRIT

Holly Fernandez Lynch @hollylynchez.bsky.social · 18d

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

Yale CRRIT @yalecrrit.bsky.social · 20d

And advisory committees can be used to assess risks and benefits of drugs in a less politicized setting

Full story: kffhealthnews.org/news/article... (3/3)

Under Trump, FDA Seeks To Abandon Expert Reviews of New Drugs - KFF Health News

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and abandoning them doesn’t make sense, former officials said.

kffhealthnews.org

Yale CRRIT @yalecrrit.bsky.social · 20d

CRRIT Co-Director @reshmagar.bsky.social expressed concern for this, noting to @kffhealthnews.org that FDA advisory committees have a role in settling disagreements within the FDA regarding regulatory decisions (2/3)

Yale CRRIT @yalecrrit.bsky.social · 20d

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)

Yale CRRIT @yalecrrit.bsky.social · 28d

This team was comprised of @yaleschoolofmed.bsky.social Maryam Mooghali, CRRIT Co-Director @reshmagar.bsky.social, Icahn School of Medicine Ayman Mohammad, and @mskcancercenter.bsky.social Aaron Mitchell (4/4)

Full article: academic.oup.com/jnci/advance...

academic.oup.com

Yale CRRIT @yalecrrit.bsky.social · 28d

While promotional payments to prescribers mostly decreased, payments continued for some drugs after failed confirmatory studies until they were withdrawn from the market (3/4)

Yale CRRIT @yalecrrit.bsky.social · 28d

Key points: 2009-2021: of the 73 drugs with accelerated approval, 6 were approved for single indications and had negative confirmatory studies with available OpenPayments data. (2/4)