@PinkSheetSutter

Senior Editor, Citeline's Pink Sheet, covering US FDA drug and biologic regulation and approvals. Views are my own. @PharmaPinkSheet

 Washington, DC
pink.citeline.com
Joined June 2010
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  • Followers2.9K
13Media
Sue Sutter retweeted
Derrick@dgingerySep 8
For those keeping track ... Capt. Sarah Meyer of the CDC is no longer listed as a member of the @FDA Vaccines and Related Biological Products Advisory Committee. Her term was set to expire in 2028.
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Brian Reid@brianreidSep 3
Good catch by Cathy Kelly and Pink on this. BridgeBio didn't note the orphan drug exception in their release, but they appended it to the 8-K. Hmmm. I'm curious what other companies have that orphan provision baked in.
Pink Sheet@PharmaPinkSheetSep 3
The orphan drug exemption in BridgeBio's Most Favored Nation agreement with the Trump Administration suggests other companies also may have unique provisions. insights.citeline.com/pink-s…

BridgeBio’s MFN Pact Exempts Orphan Products, Highlighting Deals’ Bespoke Nature

The orphan drug exemption in BridgeBio's Most Favored Nation agreement with the Trump Administration suggests other companies also may have unique provisions.

insights.citeline.com
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Sue Sutter retweeted
Mandy Jackson@ScripMandyAug 31
Notable that none of these companies involved in today’s MFN deals with the Trump administration are members of the Midsized Biotech Alliance of America, formed to lobby on behalf of mid-sized drug makers on policy issues like MFN. midsizedbiotech.com/about/

About - MBAA

Who We Are – America’s Biotech Backbone MBAA was founded to represent and protect the interests of midsized biopharmaceutical innovators which is an essential segment of America’s life sciences...

midsizedbiotech.com
Maaisha Osman@MaaishaOAug 31
Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB signs MFN deals: whitehouse.gov/fact-sheets/2…

Fact Sheet: President Donald J. Trump Announces Deal with Nine Additional Pharmaceutical Manufact...

ADVANCING MOST-FAVORED-NATION (MFN) PRICING: Today, President Donald J. Trump announced nine new agreements with pharmaceutical manufacturers to

whitehouse.gov
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Replying to @adamfeuerstein @NedPagliarulo
I'm surprised the Senate doesn't have a café called "Strong Concerns," what with how often legislators have them and swallow them anyways.
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Sue Sutter retweeted
Maaisha Osman@MaaishaOAug 18
NEW: Outgoing Georgia Congressman Buddy Carter Eyed For FDA Commissioner insights.citeline.com/pink-s…

Trump To Nominate White House Advisor Overton As FDA Commissioner

Overton, a physician and Domestic Policy Council deputy, was the summer front-runner among three finalists before Rep. Buddy Carter emerged late. She would take over an agency thinned by the 2025...

insights.citeline.com
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Sue Sutter retweeted
Derrick@dgingeryAug 13
The PDUFA VIII commitment letter is posted! Enjoy ... (but if you have been reading the @PharmaPinkSheet you already know a lot of what's in it): fda.gov/media/193977/downloa…
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#CDC's new director clearly has been sworn in. Erica Schwartz is now listed on CDC's website as the director. First big challenge for Schwartz: how she responds to this week's executive order on reducing recommended childhood vaccines & the call to break up MMR vax. cdc.gov/about/leadership/dir…

CDC Director

Erica Schwartz, MD, MPH, JD (RADM, USPHS, RET)

cdc.gov
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Sue Sutter retweeted
Max Bayer@maxonwifiAug 10
We may not get a better MAHA split screen this admin. AM: Popular GRAS reforms PM: Unpopular MMR vaccine change, autism claims
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PRV Watch
@PRVWatchJun 13
Sanofi $SNY receives approval for Tzield (teplizumab) to treat pediatric stage 3 T1D. Sanofi was awarded a Commissioner's National Priority Voucher for this indication but its unclear if this approval was still under the CNPV program as the decision has been delayed for months.
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SCOTUSblog
@SCOTUSblogMay 14
NEW: Court allows mail access to abortion pill for now. Justices Thomas and Alito dissented. supremecourt.gov/opinions/25…
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Sue Sutter retweeted
Dan Diamond
@ddiamondMay 12
The Senate appropriations committee has formally postponed its hearing tomorrow on FDA's budget. Makary had been preparing to testify.
Dan Diamond
@ddiamondMay 12
The Marty Makary era is ending at FDA. Commissioner plans to resign today, ppl tell @rachel_roubein and me, and confirming @davidalim @Gardner_LM. washingtonpost.com/health/20…

FDA chief resigns amid agency turmoil

Commissioner Marty Makary’s exit is the latest shake-up at the Department of Health and Human Services, with some officials selected by Health Secretary Robert F. Kennedy Jr. being swapped out for...

washingtonpost.com
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Sue Sutter retweeted
SCOTUSblog
@SCOTUSblogMay 7
Louisiana urges Supreme Court to leave in place order barring mailing of abortion pill scotusblog.com/2026/05/louis…

Louisiana urges Supreme Court to leave in place order barring mailing of abortion pill

The state of Louisiana on Thursday afternoon urged the Supreme Court to leave in place an order by the U.S. Court of Appeals for the 5th Circuit that prohibits the mailing of mifepristone, one of two…

scotusblog.com
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Sue Sutter retweeted
Lexi Solomon@SolomonLexiBApr 30
Young journos, if I can give you one piece of advice, let it be this: Do not normalize not having boundaries. Take it from someone who's been there - in the moment, it might feel OK sacrificing your vacation, your after-hours peace, your sanity. But it will catch up with you.
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Sue Sutter retweeted
Derrick@dgingeryApr 29
The FR notice will publish tomorrow and start the clock on whether to seek a hearing on the Tavneos withdrawal. One of my @PharmaPinkSheet stories: US FDA Details Data Manipulation, False Statements In Tavneos Withdrawal Request insights.citeline.com/pink-s…

US FDA Details Data Manipulation, False Statements In Tavneos Withdrawal Request

A re-adjudication of some patients in the ADVOCATE trial, which impacted the results, was not disclosed in the NDA, the agency said in a letter to current sponsor Amgen.

insights.citeline.com
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Sue Sutter retweeted
Alex Wayne@aawayneApr 24
Huge news: I have just been informed that healthcare is now one word in @APStylebook
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Can you use a Commissioner's National Priority Voucher twice? @PinkSheetSutter flags another unique aspect of this program, which was launched without rulemaking or guidance and has raised a lot of questions about politicized decision-making. insights.citeline.com/pink-s…

CNPV For Life? Lilly’s Foundayo Filing Plans Suggest Voucher Can Span Indications

Orforglipron was approved for obesity under the Commissioner’s National Priority Voucher pilot, but Eli Lilly also plans to submit the oral GLP-1 agonist for type 2 diabetes using the voucher...

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CNPV For Life? Lilly’s Foundayo Filing Plans Suggest Voucher Can Span Indications — Click image below to read more! || #PinkSheet | Start your free trial today: vist.ly/4yvuf vist.ly/4yvue

app-insights-trial

Our award-winning publications that go beyond the headlines, providing in-depth coverage and analysis of what matters most. Start your free trial today.

citeline.com
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At a time when Congress and the FDA alike are pushing for more unannounced inspections of foreign firms, this feels like a notable shift in tactics that could increase public attention. fda.gov/inspections-complian…
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Regarding dissolving the ACIP- I have now been told that this was a miscommunication, and in fact the decision about how to proceed has not been made, and dissolving and reforming remains one of options being considered.
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Sue Sutter retweeted
STAT
@statnewsMar 19
STAT FDA reporter @LizzyLaw_ asks HHS chief counselor Chris Klomp about the turnover at the FDA. Klomp: “When I see turnover in any organization — could be the FDA, it could be another — it's worrisome…” #STATBreakthrough
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