Who wrote the memos that led to CDC schedule changes for COVID vaccines last May? Why NIH and FDA political appointees of course. Nice find from @pinksheetsutter.bsky.social in court docs over ongoing AAP litigation over various Trump-era vaccine policy. First time these docs are public.
Thanks for the plug, Sarah!
CDC ACIP meeting announcement for March 18-19 - agenda items include discussions on COVID-19 vaccine injuries and Long-COVID. Recommendation votes may be scheduled for COVID-19 vaccine injuries and Long-COVID and ACIP recommendation methodology.
When you count the non-Guild represented people the Post laid off last week, it's close to half the newsroom,
@farhip.bsky.social writes:
What US government body meets on Dec. 29 in the absence of a public health emergency like a pandemic? Why, it's the Advisory Commission on Childhood Vaccines, of course. public-inspection.federalregister.gov/2025-22982.p...
As with the last few ACIP meetings, committee can't quite get its act together to vote.
SCOOP: FDA Office of New Drugs director not approached about CDER's top post, but also not interested insights.citeline.com/pink-sheet/a...
Another senior staff loss at US FDA - Dionna Green, former director of the Office of Pediatric Therapeutics, joins Canal Row Advisors
$GSK Blenrep is back! @US_FDA approves belantamab, in combo w/ bortezomib and dexamethasone, for treatment of adults with r/r multiple myeloma who have received at least 2 prior lines of therapy. Approval follows negative adcomm in July and a user fee date extension
@fda.gov grants accelerated approval to Stealth Biotherapeutics' elamipretide, the first treatment for Barth syndrome
The COVID-19 workgroup finally put their recommendations - the ones that ACIP will vote on - up.
The operative part - what's in ACIP's power - is that anyone can only get the vaccine under shared clinical decision making, and they essentially recommend against it for most people under 65. 1/2
Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making.
VOTE: The pediatric vaccine schedule should be updated to reflect the following change:
If a mother tests HBsAG-negative: The first dose of the Hepatitis B vaccine is not given until the child is at least one month old.
For hepatitis B vaccine:
VOTE: All pregnant women should be tested for hepatitis B infection.
@CDC #ACIP anticipated votes today.
For measles, mumps, rubella and varicella vaccines given before age 4 yrs, combined MMRV vaccine is not recommended.
Children in this age group should receive separate MMR and V vaccines
new CDER head so familiar with FDA he blamed Peter Marks for Aduhelm... (Marks was head of CBER and Aduhelm was approved by CDER)
www.realclearpolicy.com/2025/04/01/w...
Oh, this is gonna be a fun one, today.
"I am very concerned," Makary writes. "Historically, there has been a delayed recognition of fast-growing trends, such as opioid abuse and vaping addiction in youth. Let’s be proactive in understanding and addressing the use of tianeptine products."
FDA Commissioner Martin Makary "Dear Colleagues" letter warns about rising number of AEs involving products containing tianeptine, aka "gas station heroin"
US FDA announces 3 days of adcomms: May 20-21 #ODAC on four drugs; May 22 #VRBPAC on COVID vaccine formulation for 2025-2026
the thing that is being watched closely now is not just how much RFK inserts himself into FDA decisions but how much Makary and his commissioner's office inserts himself into certain decisions the commissioner's office also has traditionally stayed out of.
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...
Instead, FDA employees were encouraged to share with their children online information about the agency's work
I'm told there are no US FDA-hosted activities for Bring Your Child To Work Day this year, marking a change from past years
Fun fact from #ACIP meeting - Each measles case can cost $30,000 to $50,000 in public health response work. There were 712 reported cases in US as of April 10. I'll let you do the math.
FDA, NIH Rare Disease Day, which was postponed in late February, now officially cancelled
"due to ongoing logistical and timing challenges"
Must-read take from John Coster on how states might try to limit drug costs in Medicaid, including closed formularies, if Congress succeeds in cutting hundreds of billions of dollars from the program. "You can't cut all this money and then tie states' hands and say, 'Well, you can't do that.'" (1/2)
Pink Sheet SCOOP: Lola Fashoyin-Aje among several staffers in FDA's cell/gene therapy office leaving the agency. My colleague Derrick Gingery with the story insights.citeline.com/pink-sheet/a...
One of the 5 things HHS officials aren't doing is appearing at HIMMS.
STAT's @brittanytrang.bsky.social: "I ran into a group of conference attendees who were gathering confusedly outside a room where Medicare officials were supposed to be speaking. This is what the room looked like instead:"
