Now out in @NEJM is a piece from @jsross119, @berg_karina, & me on how @US_FDA's recent accelerated approval of #lecanemab highlights the agency's expanded use of the expedited review pathway & concerns this raises for patients, caregivers, & clinicians:

ACA Insurers Are Raising Premiums by an Estimated 26%, but Most Enrollees Could See Sharper Increases in What They Pay https://t.co/nKBlRM5whc

Rather than strengthening Medicare negotiation, bills have passed to further exempt or delay negotiation for even more drugs approved for rare diseases. For example, price negotiations for Jakafi, approved for rare bone marrow cancer and other non-rare blood conditions, are

I'll be at the Senate @GOPHELP @HELPCmteDems tomorrow to testify on "The Future of Biotech" raising how ongoing challenges threaten our ability to deliver truly lifesaving treatments to patients and what Congress and health agencies can/must do. Tune in!

In May 1998, FDA established the use of confirmatory evidence but did not issue any further public guidance until Dec 2019 when they clarified confirmatory evidence to be "additional trials, animal studies, and evidence from drugs in same class" This paper from @Yale_CRRIT

NEW: I talked with the nine companies that won FDA priority review vouchers and asked them how they did it:

We are excited to share a recently published article in @editorjoppp, which investigated the therapeutic benefits of the most expensive drugs covered by Medicare and Medicaid (1/3)

Measles cases continue to rise while the White House has used this shutdown to gut capacity from the @CDCgov, the public health agency that would be leading efforts to stop/slow this epidemic. Plus also casting doubt on vaccines known to prevent this.

"There’s no specific requirement that the FDA block out drug names on inspection reports about foreign facilities. Still, [it] preemptively kept that information hidden, invoking a cautious interpretation of a law that requires the government to protect trade secrets."

"Permissive" and "more expansive view" due to staff cuts usually means greater regulatory flexibility or allowing for greater uncertainty for patients and clinicians around whether these drugs actually work or are safe at the time of FDA approval. There's always a tradeoff.

An eye-opening piece in @statnews today peeking behind the curtain at the @US_FDA on how the politicization at the agency led to seeking out evidence for a conclusion already made. “It’s like the tail wagging the dog. Go find data to support this. Go find data to support that.”

Thank you so much for having me! It was such an honor to be invited and to meet the Skolnick family as well as the wonderful internal medicine and preventative medicine residents at Mount Sinai.

In @NatureMedicine, Caleb Rhodes (@PennMedicine), @HollyLynchez (@PennMEHP/ @PennCarey_Law) & @reshmagar (@YaleMed) outline strategies to help strengthen the integrity of @US_FDA drug approval decisions https://t.co/nJ4tWRapu2

Our brief is linked here: 6/ https://t.co/hR5GnJi8ta

🚨 New from the Science, Health & Information Clinic at @nyulaw!🚨 An amicus brief in Vanda v. United States, on federal agencies' legal authority to use & disclose private trade secrets. A case you probably haven't heard of, but with major consequences for federal regulation! 🧵

BREAKING: Friday night massacre underway at CDC. Dozens of "disease detectives," high-level scientists, entire Washington staff and editors of the MMWR (Morbidity and Mortality Weekly Report) have all been RIFed and received the following notice:

We are excited to share a recently published article in @JHPPL which investigates the past, present, and future of @US_FDA reforms. As numerous changes occurring at the agency threaten public trust and scientific rigor, there is still opportunity to reenvision the future (1/3)

Look at the damage that has already been done - this on top of cutting access to affordable health insurance, telehealth services, and so much more. As one of my patients said recently, "I think they're trying to kill us."

Truly a Freaky Friday -- further cutting public capacity that has already been gutted once after #DOGE came through will not #MakeAmericaHealthyAgain, but will harm patients and public health. https://t.co/4KcX5d6nrv #MAHA

Not only did most people hear about the White House inappropriately linking Tylenol with autism, many think this may be probably/definitely true. Republican, Democratic, it doesn't matter - these are all potential patients being misled by our top health officials. @drsforamerica

Great news segment by @NBCNews of our CRRIT/@YaleMed/@YaleSOM/@CSPI study examining IV hydration spa regulation & practices (1/3)