Sue Sutter

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

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

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.

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdow...

insights.citeline.com/pink-sheet/p...

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...

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)

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...

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:"

BREAKING: Some Laid Off FDA Employees Called Back To Work Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

Breaking news on the FDA lay offs from my colleague Sarah Karlin-Smith insights.citeline.com/pink-sheet/a...

Big FDA/NIH Rare Disease Day event scheduled for Feb. 27-28 POSTPONED, no doubt another victim of the Trump Administration transition and HHS communications freeze. "We want to make sure we can fully focus on the event to make it the best that it can be," email to registrants says.

After US FDA Diversity Action Plan, Sex Differences Webpages Restored Will Others Follow? A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidentia...

Guidance documents on clinical trial diversity action plans and sex differences in clinical evaluation of medical products are back up on FDA's website this morning after this court order yesterday
insights.citeline.com//pink-sheet/...

To Acting Secretary Fink and Acting Director Monarez: We are writing on behalf of the 1,400 members of the Association of Health Care Journalists, to protest the removal of vital public health data from the CDC website, including survey results from the Youth Risk Behavioral Surveillance System, the CDC’s Social Vulnerability Index, and AtlasPlus, an interactive CDC tool with years of data on social determinants of health and diseases including HIV, TB, and STDs. These data are used by journalists every day to report stories about public health. At a time when the rise in chronic illnesses and harmful behaviors among young people is at the top of the national agenda, the YRBS data on smoking, vaping, drinking, eating, exercise, and sexual behavior are crucial for reporters trying to inform the public about these issues. The county-level Social Vulnerability Index data is important to inform reporting on communities’ resilience and ability to respond when faced with disasters such as wildfires and severe weather. Even the temporary removal of such data will impair our members’ ability to give the public essential and timely health information. We request the immediate restoration of sites that have been taken down in recent days, and that the agency not take down other pages with critical health data. Sincerely, Felice J. Freyer, president Gideon Gil, vice president Andrea Waner, interim executive director Association of Health Care Journalists

An urgent message from the nation's health journalists:

Resurfacing in the light of day: People should archive their favorite CDC datasets today, namely ones around race/ethnic diversity, LGBTQ, flu, covid, reproductive health...

🏈📺This Hims Super Bowl ad leans very hard into the "pharma bad" / MAHA angle.

Looks like these guy are picking a fight (in part over compounding, but swinging bigger than that) with pharma:

www.youtube.com/watch?v=l5l6...

US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame? A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A 5 February meeting on postmarketing requirements for extended-release/long...

It appears US FDA adcomms starting to feel impacts from Trump Administration policies insights.citeline.com/pink-sheet/p...