Someday I will not have to write about Sarepta Therapeutics and their ineffective drugs that never should have been approved by the FDA in the first place. This is not that day.

Exactly. This is explicitly building political favoritism into the FDA review process.

I’m pretty sure that this trained medic, whatever else you may think about him, totally knows there’s no such thing as a 650% discount.

$AZN will pay you to use their inhalers

Scoop: FDA confirms it's shaking up its university collaborations this year, under what's known as its CERSI program (5-yr, $50M collabs w/the likes of Hopkins, MD, UCSF-Stanford, Yale-Mayo Clinic) - endpoints.news/fda-to-rewor...

The CDC is an emergency response agency, whether that means responding to a cancer cluster, a measles outbreak, lead poisoning or the next pandemic. I spoke with @cnn.com about how chaos there jeopardizes the country. kffhealthnews.org/news/article...

more vertical integration in health care... Cigna invests in Shields Health Solutions a specialty pharmacy company that just acquired the PE firm that just acquired Walgreens... the web of connections is a bit headspinning... nam04.safelinks.protection.outlook.com?url=https%3A...

Vinay Prasad had YouTube censor Jonathan Howard’s channel because he didn’t like how it made him look. A petty act by a vindictive, unqualified hack. And more evidence that these frEe sPeEcH warriors have always been petty censors out to silence criticism that they just can’t cope with.

Endpoints: Kennedy pledges support for mRNA cancer vaccines despite decrying mRNA for Covid by @zacharybrennan.bsky.social bit.ly/41ztoTm

This is a crime. I can’t put it any other way.

This is ominous. open.substack.com/pub/pauloffi...

NEW: With deep job cuts at the FDA, inspectors say the ongoing strain could compromise policing an industry spread across more than 90 countries. “Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.

6 (from today). RFK says he made no promises to Cassidy

Things are very bad for U.S. vaccination policy these days and are only going to get worse. In @nejm.org, I examine the recent news about COVID-19 vaccines and ACIP, what likely lies ahead, and what the medical and public health communities should do to lessen the damage www.nejm.org/doi/full/10....

New CDC advisers will skip some expected topics and explore a target of antivaccine activists apnews.com/article/acip...

BREAKING: The FDA has approved a twice-yearly injection that provided a near-perfect shield against H.I.V. infection in clinical trials. But the Trump administration has gutted the programs that might have paid for it in low-income countries (Gift article) www.nytimes.com/2025/06/18/h...

👀

Feeling a lot like I did in early days of the pandemic these days. It is so clear what’s coming: The people that will die because of cuts in global health, because of cuts to research, because of the concerted anti-vaccine push. It’s clear what’s coming, but we will have to wait to count the dead.🧪

Viewpoint: The FDA's non-standard review of Novavax's #COVID19 vaccine raises concerns about regulatory integrity and the influence of political considerations on public health decisions. https://ja.ma/3TepavL

Reminder: Nobel-prize winning PCR (1983), used in basically all genetic tech today, was only possible because of extremophile bacterium discovered in 1964 in Yellowstone funded by a small ~$80k NSF grant with no obvious application at the time. #science 🧪 www.richmondscientific.com/how-a-discov...

the 10 out, 1 in policy is agency-wide, not at all specific to cell/gene therapies and there was no mention at that meeting of deregulating or changing any regs (RFK was talking about adding some, and asking for requests/lists on which to cut)

So it looks like #ACIP will be meeting later this month. It will be interesting. 🍿 public-inspection.federalregister.gov/2025-10432.pdf

An increase of 10.9 million uninsured people, plus millions of others who will lose coverage if enhanced ACA premium tax credits expire this year, would reverse much of the gains in insurance coverage from the ACA.

NEW - A new FDA AI tool that could speed up reviews of medical devices is struggling with simple tasks, like uploading documents, according to two people familiar. A separate tool, called Elsa, which was rolled out to FDA employees Monday is also having issues. www.nbcnews.com/health/healt...

Meet the FDAers who were cut by DOGE but still get paid in full w/benefits as they look for new work (going on month 3 now..) endpoints.news/laid-off-fda...

For pregnant women, CDC now lists COVID-19 vaccines during pregnancy as "No Guidance/Not Applicable" www.cdc.gov/vaccines/hcp...

This is what happens when you put internet conspiracy theorists in charge of major government departments.

If someone has to read halfway through your story before finding out Kennedy's step on COVID vaccination today is not in alignment with the scientific evidence you are doing it wrong.

These ACOG views were based on a significant studies. it will be interesting to see if the recommendation against vaccination is based on new evidence or some kind of interpretation of the old evidence. www.acog.org/news/news-re...

The House reconciliation bill would penalize states to the tune of $92 billion if they use their own funds to provide health care to undocumented immigrants. www.kff.org/medicaid/iss...

Goddamn. The dek really says it all.

Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all. www.nytimes.com/2025/05/15/h...

The guy who demanded his predecessors do RCTs and bashes Big Pharma trials is suddenly going to pivot and claim the government has no role in generating evidence, and only Big Pharma trials are reliable.

This is the equivalent of someone asking where Albany is located and you wrongly guess Vermont, and they say, “No, actually, it’s the United States.”

RFK Jr. said multiple times during his house and senate hearings today that no scientists have been fired from federal agencies. Our reporting has shown that hundreds, if not thousands, of scientists have been let go from NIH/CDC/FDA

ACF falls under HHS…there were quite a few gaffes in this exchange from Alsobrooks too

"For me, the answer now lies in refusal, the withdrawal of participation from systems that require dishonesty as the price of belonging." Today I am resigning from the National Science Board and the Library of Congress Scholars Council. I wrote about my decision in TIME. time.com/7285045/resi...

Robert F. Kennedy Jr., the health secretary, posted photos on Sunday of himself and his grandchildren swimming in a contaminated Washington creek where swimming is not allowed because it is used for sewer runoff.

After FDA firings, drug reviewers are asked to volunteer for administrative work endpts.com/after-fda-fi... #FDA #pharma

RFK Jr. ordered the NIH’s Integrated Research Facility in Frederick to stop all research on serious infectious diseases yesterday at 5:00 PM. They study pathogens like Ebola there. You may be familiar with it from The Hot Zone. www.wired.com/story/hhs-ni...

A wave of early retirements at OND and elsewhere across CDER recently took effect, following the April staff cuts t.co/I8lE4ZgtuR

“As alleged, Gilead spent tens of millions of dollars on these programs, including over $20 million in speaking fees and millions more in exorbitant meals, alcohol and travel, all in an effort to induce doctors to prescribe Gilead’s HIV drugs and drive up sales.” -DOJ

Out today in @jama.com, me and @nathancortez.bsky.social examine how the drastic staffing cuts at FDA run counter to FDA's many statutory obligations and the bargains embodied in user fee provisions - and put public health, innovation, and all of us at risk. jamanetwork.com/journals/jam...

The lasting damage that the Trump administration is doing to US science is barbaric. But more and more of the general public is hearing about it and just how bad it is:

Here is the link to the Last Week Tonight with John Oliver about RFK, Jr, public health, and HHS (including NIH) www.youtube.com/watch?v=8H34...

Here is a link to 60 Minutes NIH segment... www.cbsnews.com/news/scienti...

In interviews, FDA Commissioner Makary has repeatedly claimed no scientists were laid off at his agency We spoke to laid-off scientists in some of FDA's food safety labs that were gutted by layoffs "That just made me so mad," one laid-off scientist told us www.cbsnews.com/news/fda-hea...

👀 Approvals for drugs aimed at exceptionally rare conditions could be made “on a conditional basis,” Makary said, without a randomized trial. Via @zacharybrennan.bsky.social endpts.com/fdas-makary-...

While Trump has launched a 232 investigation to tax pharmaceuticals, he's simultaneously issued an executive order to lower US drug prices. See @zacharybrennan.bsky.social coverage on this at @endpts.com: endpts.com/trump-pledge...

Trump on his plan to impose tariffs on pharmaceuticals: "All I have to do is impose a tariff. The more, the faster the move in. It's very simple -- it's inversely proportional, the higher the tariff, the faster they come."