Sue Sutter

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-co…

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.

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

On the clock: The White House has until 3/25 to nominate a new #CDC director. The Federal Vacancies Reform Act states a job like CDC director can only be filled on an acting basis for 210 days from the creation of the vacancy, though the clock stops if a nominee is named. sgp.fas.org/crs/misc/R4499…

Special thanks to Canal Row Advisors' Michael Rogers and Doug Stearn for joining our Drug Fix podcast to chat about all things inspections insights.citeline.com/pink-sheet/pod…

Just one point to emphasize: numerous reporters, myself included, asked for this briefing to be on the record. I'll be the first to admit I'm very liberal in my use of background attribution, especially if it's necessary to protect a source. This was not one of those cases.

@US_FDA ODAC MEETING ALERT! April 30 on 2 $AZN drugs: camizestrant (breast cancer) and Truqap (capivasertib) (prostate cancer)

The @US_FDA issued a final rule requiring all NDC codes to go from 10 digits to 12. Not effective until 2033 to allow for conversion, but I wonder if this will end up like DQSA implementation where problems forced delays in implementation beyond schedule: public-inspection.federalregister.gov/2026-04368.pdf

HHS and CDC said Ralph Abraham left his post as principal deputy director "to address unforeseen family obligations." Today, a week later, he's announced as Julia Letlow's campaign chair.

$QURE down this morning on comments made by FDA Commissioner Marty Makary to CNBC's Becky Quick. In a discussion about rare-disease drug approvals and Vinay Prasad, Makary said this: "I think there has been a bit of an effort to find a boogeyman to account for certain products that were not approved. For example, there was a product where the researchers drilled a burr hole, literally hole in people's skulls to interact inject intrathecally into the ventricle, a therapy the randomized control trial. At the end of the randomization period, it's found no benefit, and yet, this is one of the drugs that we were pressured to approve. Now, look, I have a lot of sympathy for those patients. There's nothing out there to offer them, but we're not going to go ahead and approve something like that that has morbidity associated with it."

@CDCgov #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.

The work that @Lescarpenter, @barrysvrluga and @RickMaese have done during the past few weeks from the Olympics has been nothing short of spectacular. Their dedication to the readers despite the destruction of The Post Sports Department is the stuff of legends.

@LizzyLaw_ Well deserved!

Honored to have won a George Polk award for my coverage of the turmoil at FDA last year. The STAT team was also recognized for reporting on the Trump admin's impact on health and science. statnews.com/2026/02/18/sta…

Having to feed a robot all of the context about who each source is, why they matter, what information is most important and why — and then correcting all of its mistakes — sounds like more work than just writing the dang article yourself

@US_FDA draft guidance on plausible mechanism of action pathway now under OMB review

Updated with a new @BaltimoreBanner @bannerpgcounty role: Apply here ->job-boards.greenhouse.io/thebaltimoreba…

@PressClubDC offering free memberships to laid off journalists: press.org/newsroom/club-…

Nice work by @LizzyLaw_ on today's internal @US_FDA town hall on the CNPV program

And the second story also FREE to read insights.citeline.com/pink-sheet/pin…

Thanks @DrMakaryFDA for posting excerpts from my @PharmaPinkSheet year in review pieces on @US_FDA #adpromo enforcement. We've made these pieces FREE TO READ in full for everyone insights.citeline.com/pink-sheet/pin…