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Sarah Karlin-Smith

@sarahkarlin-smith.bsky.social

Journalist covering intersection of pharma, health policy & politics for the Pink Sheet. On Signal at SarahKarlinSmith.34 KFF Health News’ ‘What The Health?’ panelist. Co-created Prescription PULSE at Politico. GWU alum, dabbled in SMPA adjunct-ness.

6,917 Followers  |  1,822 Following  |  2,616 Posts  |  Joined: 12.07.2023  |  2.2079

Latest posts by sarahkarlin-smith.bsky.social on Bluesky

I think this is the first time a drug company has directly been a part of these types of panels under Makary but I'm not 100 percent.

10.12.2025 19:25 — 👍 0    🔁 0    💬 0    📌 0

ironically person speaking from marius pharma is taking swipes at "big pharma."

they argue testosterone is solution to glp1 lean muscle mass loss.

10.12.2025 19:24 — 👍 0    🔁 0    💬 1    📌 0

now pharma company execs are presenting themselves at this panel.

10.12.2025 19:21 — 👍 0    🔁 0    💬 1    📌 0
Turning Point USA, upcoming conference speakers: Michael Knowles, Russell Brand, Rob Schneider, Jay Bhattacharya

Turning Point USA, upcoming conference speakers: Michael Knowles, Russell Brand, Rob Schneider, Jay Bhattacharya

Turning Point USA’s conference starts in 8 days

Of course, the NIH Director and his MAHA ally Russell Brand are speakers….along with Don Trump Jr, JD Vance, Megyn Kelly, Roger Stone….

10.12.2025 18:52 — 👍 36    🔁 12    💬 13    📌 11

they are taking some questions that were submitted to them from public it seems - I think this is new from prior expert panels and perhaps attempt to respond to some of the criticism around lack of public comment.

10.12.2025 18:40 — 👍 1    🔁 0    💬 1    📌 0

"There's a regulatory disconnection for indications for treatment and scheduling" - doc who consults for testosterone makers say.

1 thing that may seem minor - there is no written list of who is speaking that I can find so harder to get down names and affiliations.

10.12.2025 18:29 — 👍 3    🔁 0    💬 1    📌 0

I know we're only 20 minutes in but based on the FR notice and what I've heard so far seems pretty clear FDA wants to push expanding label indications for testosterone.

10.12.2025 18:23 — 👍 1    🔁 1    💬 1    📌 0

Makary just said FDA doesn't have preconceived ideas on topic right after he made just pretty opinionated statements including suggesting maybe testosterone needs to be rescheduled so it can be more accessible.

10.12.2025 18:10 — 👍 3    🔁 0    💬 1    📌 0
Preview
FDA Expert Panel on Testosterone Replacement Therapy for Men YouTube video by U.S. Food and Drug Administration

I'm covering the expert panel at FDA on testosterone replacement therapy for men today. Interested if any experts in the space are live skeeting?

www.youtube.com/live/BdAawJm...

10.12.2025 18:10 — 👍 7    🔁 3    💬 1    📌 0

"“If this administration is able to sort of run roughshod over these laws and rules that we believed to be so well established, and there is no mechanism by which there can be accountability, or that the harms can be rectified, where does that leave us?” Julia Decker, Immigrant Law Center of MN

10.12.2025 15:50 — 👍 15    🔁 7    💬 0    📌 1
Preview
Federal agents arrest citizen observer watching ICE detain neighbors on her north Minneapolis block Susan Tincher, a 55-year-old American citizen, appears to be the first observer arrested by federal immigration enforcement officers since the agency launched an immigration surge in the Twin Cities l...

“She has marks on her neck and wrist from where agents restrained her. Agents cut off her wedding ring and held her in leg shackles at Whipple Federal Building for about five hours.”

Her crime: witnessing ICE, from a distance.

09.12.2025 22:49 — 👍 2288    🔁 1446    💬 76    📌 177
Preview
The Racist Worldview Behind the New Vaccine Recommendations ACIP’s recent decision to scrap hepatitis B vaccine recommendations for infants is inextricable from its advisers’ apparent belief that immigrants bring disease.

You might have heard the CDC's vaccine advisers bring up immigration as a disease threat. Actually, outbreaks often start when unvaccinated Americans bring back diseases. My latest:

10.12.2025 13:10 — 👍 41    🔁 29    💬 1    📌 3
Preview
#fda #cpnv #publichealth #pdufa #kendallsquarepolicy | Paul T. Kim Yesterday, #FDA announced its first approval under the Commissioner's National Priority Voucher (#CPNV) pilot – of a new domestic manufacturing line for a 23-year old drug. “The approval,” declared F...

If you are following the FDA's new commissioner's national voucher program this post from Paul Kim is a must read...

"No miracles here."

www.linkedin.com/feed/update/...

10.12.2025 15:01 — 👍 4    🔁 1    💬 0    📌 0

I still find this word silly but... has anyone done any prebunking connected to the upcoming testosterone expert panel at FDA today?

nam04.safelinks.protection.outlook.com?url=https%3A...

10.12.2025 14:25 — 👍 2    🔁 0    💬 1    📌 0
Preview
US health officials re-examine RSV shots despite documented safety and efficacy The FDA is reviewing RSV vaccines, which have drastically lowered infant hospitalizations, a spokesperson confirmed

The FDA is now reexamining shots to prevent RSV -- but once again, they haven't offered any evidence for safety concerns. From me: www.theguardian.com/us-news/2025...

10.12.2025 14:04 — 👍 45    🔁 19    💬 0    📌 3
Preview
CAR-T Standards Raised As US FDA Continues Policymaking Via Journal Article Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public ...

FDA’s Good Guidance Practice regs explicitly state that FDA may not use means of comms that are excluded from the definition of guidance, such as journal articles, to ‘informally communicate new or different reg expectations to a broad public audience for the first time.' @hollylynchez.bsky.social

10.12.2025 14:21 — 👍 12    🔁 6    💬 2    📌 1
Preview
Exclusive: US FDA launches fresh safety scrutiny of approved RSV therapies for infants U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would be subject to fresh safety scrutiny followi...

RFK's FDA is now scrutinizing the new-ish RSV antibodies:

09.12.2025 12:58 — 👍 9    🔁 7    💬 2    📌 3

I felt perfectly fine biking my kids to school but once I get back inside I realize my toes are cold and will take all day to warm up.

09.12.2025 13:50 — 👍 1    🔁 0    💬 0    📌 0

Health misinformation kills and its only getting worse.

"Court records show the couple told investigators they relied on online videos and posts that warned against vaccines, infant medical treatments and even common medicines such as Tylenol."

09.12.2025 03:48 — 👍 66    🔁 32    💬 4    📌 1
Preview
FDA Slow Walking a Long-Awaited Abortion Pill Safety Study The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at Commissioner Marty Makary’s request to put it off until after the midterm elections,...

The best reading of this article: Trump is going to use FDA to restrict medication abortion, but he wants to wait until after the midterms so the Republicans don't experience blowback. But that just makes the midterms more important. www.bloomberg.com/news/article...

08.12.2025 23:20 — 👍 896    🔁 526    💬 11    📌 36

COLIN!!!

09.12.2025 02:15 — 👍 2    🔁 0    💬 1    📌 0

Thanks for flagging. I will look into it more.

09.12.2025 02:15 — 👍 0    🔁 0    💬 0    📌 0

why do you think they are not listed? They last updated on 12/5.

09.12.2025 01:58 — 👍 0    🔁 0    💬 1    📌 0
Child dies, siblings hospitalized after 'alkaline diet,' parents charged Phoenix police found a 5-month old boy dead after his mother called 911. Prosecutors blame parents for the death and for illnesses of other children.

Court docs: Parents avoided doctors, consumed pro-alkaline diet and anti-vax content, and didn't feed their kids enough protein, fats, vitamins+calories. One kid died+others now have rickets, bone density loss, vit D deficiency, and significant developmental delays.

www.usatoday.com/story/news/n...

09.12.2025 01:42 — 👍 4    🔁 3    💬 1    📌 0

Since HHS is very into Denmark lately, in Denmark families get a full year of paid parental leave. In the US some people get zero paid leave. US policies around needing to express milk at work are lacking with the lowest paid workers most harmed.

09.12.2025 01:44 — 👍 108    🔁 18    💬 6    📌 2

Let me just say: I have run more than a dozen marathons and an ultramarathon and I have worked 13-hour days in a cornfield in the scorching-ass sun, and none of those things broke me like breastfeeding.

It’s not a question of will. I am a determined person. Sometimes your body just WONT DO IT.

08.12.2025 22:16 — 👍 2156    🔁 273    💬 137    📌 16

(AP) — A federal judge has struck down President Donald Trump’s executive order blocking wind energy projects, saying the effort to halt virtually all leasing of wind farms on federal lands and waters was “arbitrary and capricious” and violates U.S. law.

09.12.2025 01:00 — 👍 40    🔁 51    💬 3    📌 2

👋 Breastfeeding & infant feeding expert here! All babies need safe, accessible nutrition. Most people already want to breastfeed and 84% start out doing so but can’t realize their goals. What we need are *policies* that make it possible to breastfeed for all who desire to do so and…

08.12.2025 21:27 — 👍 460    🔁 126    💬 8    📌 17

1. All babies need safe, secure nutrition.
2. It's up to governments (not individual women) to invest in policies that make it possible for people to meet their breastfeeding goals.
3. All families deserve transparent, evidence-based information about nutrition -- instead of stigmatizing rhetoric.

08.12.2025 22:21 — 👍 40    🔁 17    💬 3    📌 1

my issue when stuck at airport for 8 hours in june re exercise was I was by myself and I could walk but involved carrying all my stuff everywhere. a secure place to leave would have been nice.

08.12.2025 21:55 — 👍 2    🔁 0    💬 0    📌 0

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