Sue Sutter
@pinksheetsutter.bsky.social
Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own.
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...
public-inspection.federalregister.gov
December 15, 2025 at 1:59 PM
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.
Hep B votes now tomorrow...
December 4, 2025 at 6:13 PM
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...
FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
insights.citeline.com
November 7, 2025 at 2:22 AM
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
October 24, 2025 at 3:47 PM
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
October 23, 2025 at 8:05 PM
$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
Reposted by Sue Sutter
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
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
September 19, 2025 at 6:17 PM
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
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.
September 18, 2025 at 12:07 PM
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.
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.
September 18, 2025 at 12:06 PM
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.
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.
VOTE: All pregnant women should be tested for hepatitis B infection.
September 18, 2025 at 12:06 PM
For hepatitis B vaccine:
VOTE: All pregnant women should be tested for hepatitis B infection.
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
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
September 18, 2025 at 12:05 PM
@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
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
Reposted by Sue Sutter
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...
www.realclearpolicy.com/2025/04/01/w...
Why Peter Marks Was Asked to Leave the FDA
On Friday, Dr. Peter Marks announced his resignation from the U.S. Food and Drug Administration (FDA) as Director of CEBR (Center for Biologics Evaluation and Research) citing differences with Health
www.realclearpolicy.com
July 22, 2025 at 12:23 AM
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...
www.realclearpolicy.com/2025/04/01/w...
Oh, this is gonna be a fun one, today.
May 22, 2025 at 1:17 PM
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."
May 8, 2025 at 7:21 PM
"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"
May 8, 2025 at 7:21 PM
FDA Commissioner Martin Makary "Dear Colleagues" letter warns about rising number of AEs involving products containing tianeptine, aka "gas station heroin"
Reposted by Sue Sutter
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.
April 29, 2025 at 2:49 PM
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.
Reposted by Sue Sutter
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...
jamanetwork.com/journals/jam...
The FDA’s Crisis Is Everyone’s Crisis
This Viewpoint discusses the Trump administration’s firings of thousands of US Food and Drug Administration employees and the ramifications of those actions on the agency’s congressionally given publi...
jamanetwork.com
April 28, 2025 at 7:34 PM
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...
jamanetwork.com/journals/jam...
Instead, FDA employees were encouraged to share with their children online information about the agency's work
April 24, 2025 at 2:58 PM
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
April 24, 2025 at 2:56 PM
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.
April 15, 2025 at 9:23 PM
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"
"due to ongoing logistical and timing challenges"
April 15, 2025 at 5:46 PM
FDA, NIH Rare Disease Day, which was postponed in late February, now officially cancelled
"due to ongoing logistical and timing challenges"
"due to ongoing logistical and timing challenges"
Reposted by Sue Sutter
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)
States may look for savings from drug coverage restrictions if Congress imposes major Medicaid cuts, John Coster, former Medicaid pharmacy division director, predicted.
#healthpolicy
#healthpolicy
Medicaid Cuts Could Prompt States To Tighten Drug Cost Controls, Former CMS Official Says
Recently retired CMS veteran John Coster discussed potential Medicaid cuts, rebate cap elimination and obesity drug coverage in an interview with the Pink Sheet.
insights.citeline.com
March 12, 2025 at 5:44 PM
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...
CBER Losing Cell, Gene Therapy Leadership As Workforce Culling Continues
Among those now leaving the US FDA’s biologics center is Lola Fashoyin-Aje, who was considered a rising star at the agency when she became director of the Office of Therapeutic Products’ Office of Cli...
insights.citeline.com
March 12, 2025 at 6:28 PM
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...