Steven Grossman

FDA, regulatory consultant. FDA Matters. HPS Group, health policy. Stronger FDA.

[Steven Grossman @FDAMatters]

New FDA Matters column: A Marathon, Not a Sprint: The Long Road to Becoming the Next FDA Commissioner https://t.co/Mq1jWmZFDG

Around DC, there are a lot of smart people talking about the race to fill the job of FDA Commissioner. To me, it’s more of a slog than a race; certainly, more of a marathon than a sprint. It’s highly unlikely that anyone will be nominated soon, and no one will be confirmed quickly.

I explain why in my latest FDA Matters column. More coverage of my views on the timing of a new commissioner: MedPage Today https://t.co/I8bgFhEkU8 and Food Fix https://t.co/4NIbhQvb24.

#FDA #FDAMatters #FDACommissioner #Makary #ActingFDACommissioner #Diamantas #SenateHELP #FDANomination #FDAConfirmation

[Steven Grossman @FDAMatters]

There cannot be one set of rules for GLP-1compounding and another set of rules for other drug products.

As a result, the narrow exceptions that compounders want to expand would cross critical boundaries that FDA needs to preserve.

https://t.co/x8VkiCCDLI

#FDA #FDAMatters #compounding #GLP1 #FDCA #NovoNordisk #HimsAndHers #Lilly

[Steven Grossman @FDAMatters]

Words matter! Alice, Humpty Dumpty and I gaze “Through the Looking Glass” to provide insights on: radical transparency, gold standard science, and ultra-processed foods.

https://t.co/iXW1XHFlU4

#FDA #FDAMatters #RadicalTransparency #GoldStandardScience #UltraProcessFoods #UPF #FaustMD #MarionNestle

[Steven Grossman @FDAMatters]

Elon Musk thought cutting government programs was about deficit reduction. It isn’t. We need a deficit-neutral reconciliation bill that does not gut human services programs or abandon government investment in scientific research and innovation.

https://t.co/yFfnCfDMbs

#FDA #FDAMatters #DOGE #Musk #deficit #bigbeautifulbill #NIH #CDC #GovernmentInvestment

[Steven Grossman @FDAMatters]

FDA Matters recently published an important column on the need for FDA to maintain firm boundaries around all drug compounding, not just GLP-1’s. Otherwise, FDA risks creating two systems, one regulated, one not.

https://t.co/8GF8PcWe0b

#FDAMatters #DrugCompounding #GLP-1 #ObesityMedicines #DrugShortages #SpecialMedicalNeeds #ConsumerProtection

[Steven Grossman @FDAMatters]

AI is a wonderous tool now and promises to be even better in the future. However, we cannot just dismiss problems because AI is the wave of the future.

Read more here: https://t.co/FNXwoVi5PT

#FDA #FDAMatters #FDAAI #AI #MAHA #AI #AIatFDA #Makary #ShannonLantzy #FDADownsizing

[Steven Grossman @FDAMatters]

Budget reconciliation shortfalls threaten discretionary spending. In the face of fiscal hawks, Senator Collins may not have enough funds to protect public health agencies (FDA, NIH, CDC)

Read more here: https://t.co/BuDGA556Bb

#FDA #FDAMatters #NDD #NIH #SusanCollins #FDAbudget #appropriations #fiscalhawks #CDC

[Steven Grossman @FDAMatters]

Today, May 22, 2025, is the last day that mass compounded GLP-1 obesity medicines can be sold. Yet, some companies intend to continue selling compounded GLP-1 drugs by gratuitously adding other ingredients or making similar modest and unnecessary changes in dosing.

The hypocrisy is clear: a special medical need is not a mass need.

https://t.co/8GF8PcWe0b

#FDA #FDAMatters #FDApolicy #GLP1 #FDAapproved #FDCA

[Steven Grossman @FDAMatters]

The most important questions facing FDA are about whether it can carry out its responsibilities. It’s too soon to know. Meantime, we are monitoring the situation and can report some encouraging signs of progress.

https://t.co/Ksobx5X9vm

#FDA #FDAMatters #FDAMakary #FDAcommissionerMakary #FDArehiring #FDAuserfees #AI

[Steven Grossman @FDAMatters]

Our ability to see FDA’s direction and predict its future depends on the resolution of several unknowns. The potential for norm-breaking by the Administration multiplies the scenarios and makes each situation opaque.

https://t.co/nL3mAb5nbn

#FDA #FDAMatters #SecretaryKennedy #CommissionerMakary #FDAdeadlines #FDAstaff #MAHA

[Steven Grossman @FDAMatters]

Picking Apart the Destructive Claim That Industry Controls FDA. Examines the revolving door, DOGE RIF’s, and the way FDA makes product decisions. Analysis, not news coverage.

https://t.co/2PN3ePuXnX

#FDA #FDAMatters #RevolvingDoor #FDADecisions #RIF #DOGE #IndustryControlofFDA

[Steven Grossman @FDAMatters]

FDA Matters analysis: Dr. Prasad’s prior statements do not bind his actions as the new CBER director. We expect strong leadership, not harsh judgments, as he goes from outsider to insider.

https://t.co/O9gzrTvX3y

#FDA #FDAMatters #CBER #NewCBERleadership #Prasad #Makary #PeterMarks #biotech #vaccines #cellandgenetherapy

[Steven Grossman @FDAMatters]

Once Commissioner Makary knows better what he can and cannot do, he needs to forthrightly address the shorter term. It is not pocket change: medical products companies have a $5 billion financial commitment to FDA for activities in FY 26 and FY27

https://t.co/JcCbWEJePE

#FDA

[Steven Grossman @FDAMatters]

The American People in the Hands of an Indifferent Government
FDA Matters: Downsizing doesn’t require indifference to human needs

https://t.co/ieyPD3NgB3

#FDA #FDAMatters #TheGrossmanFDAReport #Downsizing #Congress #DOGE

[Steven Grossman @FDAMatters]

FDA and Politics: An Unhealthy Combination
https://t.co/Ep77ezUehC

The topic speaks for itself! Sign up to receive future columns at https://t.co/21PVwnERnI

#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #politics

[Steven Grossman @FDAMatters]

Leaked FY 26 OMB budget passback to HHS circulating. Here is Steven’s analysis.

https://t.co/h4mwfL7xjV

#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr

[Steven Grossman @FDAMatters]

Rx for FDA: An Agenda for the Commissioner. Ideas for moving forward.

Read the latest from FDAMatters — The Grossman FDA Report:

https://t.co/h12xnlPDpr

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr #FDAcommissioner

[Steven Grossman @FDAMatters]

The latest from FDAMatters — The Grossman FDA Report:
Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA

Read it here: https://t.co/C8cqDrvCSk

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #userfees #deregulation #cspi #politico

[Steven Grossman @FDAMatters]

New Administration’s Food Priorities Require Resources, Expertise, and Regulations: Where Will They Come From?
First appeared in Food Safety News. Reprinted with permission: https://t.co/7miN8GFk8B
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #rfkjr #maha

[Steven Grossman @FDAMatters]

RIF’s at FDA are random and arbitrary and that tells us a lot about what the Administration intends. We need to start focusing on Commissioner Makary immediate challenges: assessing what FDA can and cannot do with remaining staff and restarting the engine of production.

#FDA