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. www.fdamatters.com/fdamatters/a... #FDA #FDAMatters #compounding

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. www.fdamatters.com/fdamatters/a... #FDA #FDAMatters #GoldStandardScience #UltraProcessFoods #UPF #FaustMD #MarionNestle

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. www.fdamatters.com/fdamatters/e...

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. www.fdamatters.com/fdamatters/a... #FDAMatters #DrugCompounding #GLP-1

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: www.fdamatters.com/fdamatters/t... #FDA #FDAMatters #FDAAI #AI #MAHA #AI #AIatFDA #Makary #ShannonLantzy #FDADownsizing

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) www.fdamatters.com/fdamatters/n... #FDA #FDAMatters #NDD #NIH #SusanCollins #FDAbudget #appropriations #CDC

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. www.fdamatters.com/fdamatters/a... #FDA #FDAMatters #FDApolicy #GLP1 #FDAapproved #FDCA

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. www.fdamatters.com/fdamatters/f... #FDA #FDAMatters #FDAMakary #FDArehiring

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. www.fdamatters.com/fdamatters/i... #FDA #FDAMatters #RFKjr #Makary #MAHA

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. www.fdamatters.com/fdamatters/p... #FDA #FDAMatters #RevolvingDoor #FDADecisions #RIF #DOGE #IndustryControlofFDA

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. www.fdamatters.com/fdamatters/n... #FDA #FDAMatters #CBER #Prasad #Makary #PeterMarks #biotech #vaccines

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 www.fdamatters.com #fda #FDAmatters #FDAuserfees

The American People in the Hands of an Indifferent Government FDA Matters: Downsizing doesn’t require indifference to human needs www.fdamatters.com/fdamatters/t... #FDA #FDAMatters #TheGrossmanFDAReport #Downsizing #Congress #DOGE

FDA and Politics: An Unhealthy Combination www.fdamatters.com/fdamatters/f... The topic speaks for itself! Sign up to receive future columns at www.fdamatters.com #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #politics

Leaked FY 26 OMB budget passback to HHS circulating. Here is Steven’s analysis. www.fdamatters.com/fdamatters/l... #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr

Rx for FDA: An Agenda for the Commissioner. Ideas for moving forward. Read the latest from FDAMatters — The Grossman FDA Report: www.fdamatters.com/fdamatters/r... --- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #makary #rfkjr #FDAcommissioner

The latest from FDAMatters — The Grossman FDA Report: Chesterton’s Fence: The Meaning of Deregulation & Other Thoughts About FDA Read it here: www.fdamatters.com --- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #rif #userfees #deregulation #cspi #politico

The latest from The Grossman FDA Report: The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking www.fdamatters.com/fdamatters/t... --- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts

The latest from The Grossman FDA Report: The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking www.fdamatters.com/fdamatters/t... --- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts

New Administration’s Food Priorities Require Resources, Expertise, and Regulations: Where Will They Come From? First appeared in Food Safety News. Reprinted with permission: www.fdamatters.com/fdamatters/n... ------------ #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #rfkjr #maha

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 #FDAMatters

FDA is immeasurably worse for Dr. Marks’s departure, as are the American people. A very bad week for FDA. I see two pressing needs….. Read “You are Entitled to Your Own Opinions, But Not to Your Own Facts.” www.fdamatters.com #FDA #FDAmatters #FDArif #PeterMarks #TheGrossmanFDAReport #DrMarks

Steven answers questions about the FDA RIF: Relative to the FDA workforce, how big is the RIF? Will the RIF exemption be “reviewer” or “reviewer teams,” “inspectors” or “inspector teams?” Will so-called “user fee employees” be protected from the RIF? and more on www.fdamatters.com today!

The topic: government downsizing in the 1990’s and now. Steven takes an historical view of the political dynamics of each and addresses the larger question of how much government Americans want. www.fdamatters.com ---- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #federalworkers #govtdownsize

"We are going to eliminate FEMA," @Sec_Noem (on X) says in Cabinet meeting with Trump. (h/t @JenniferJJacobs on X) Steven's thoughts: www.fdamatters.com/fdamatters/p... -- #FDA #FDAMatters#TheGrossmanFDAReport #FDApolicy #trump #FEMA

What Is Happening to FDA Employees? An Analogy Can Help Read about it here: www.fdamatters.com/fdamatters/y... ------------------------------- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #federalworkers #rfkjr #deficitreduction

Join The Obesity Society (TOS) on Wed., March 19, 12pm ET for a briefing on the risks of compounded obesity drugs. This event is open to patient and provider advocacy groups, Capitol Hill staffers, regulatory professionals, media, and the public. Register here: bit.ly/41BNN9J

My latest post: The MAHA Challenge: Can It Lead to a Healthier and Safer Food Supply? The latest from FDA Matters, The Grossman FDA Report. Read here: www.fdamatters.com --- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #maha #rfkjr #foodpolicy #healthyeating

Zero-Based Defense (ZBD) of Critical Government Programs, Passage of FY 25 CR: FDA Level-Funded But Other Programs Hit, Multiple Budget Battles Yet to Come: FDA at Continued Risk, What I am Reading: Proposed Cuts to Medicaid. Read more: www.fdamatters.com #FDA #FDAMatters

The latest from FDA Matters, The Grossman FDA Report: What I Learned By Speaking About “FDA in Trump 2.0”. Read here: www.fdamatters.com ------------------------------- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #AmericasBloodCenters

FDA Matters, The Grossman FDA Report: Taken from This Week’s Headlines, Makary Makes Commitments to Senators, March 14 Government Shutdown Cannot Be Ruled Out, User Fees Still Likely and more. fdamatters.com ----- #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy

Today's edition of FDA Matters: The Grossman FDA Report: "Lessons from Dr. Gottlieb’s 2017 Confirmation Hearing" Read it here: www.fdamatters.com/blog. ------------------------------- #FDA #FDAMatters #TheGrossmanFDAReport #FDAMakaryConfirmation #FDAGottlieb #FDApolicy

I need a break from politics. Maybe you do, too? Let’s talk instead about living longer and healthier. Live event tomorrow. www.fdamatters.com/blog ----------- #FDA #FDAMatters #TheGrossmanFDAReport #FDAregulations #FDApolicy #healthspan

FDA Matters, The Grossman FDA Report: Never Lose the Whip Count, The Disconcerting Consequences of Lay-Offs By Fiat, and User Fees & layoffs at FDA. www.fdamatters.com/blog ------------------------------- #FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAlayoffs

FDA, RIF's, and User Fees Explained in today's SPECIAL EDITION of FDA Matters: The Grossman FDA Report: www.fdamatters.com! ------------------------------ #FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAregulations #FutureofFDA #FDARIF #RIF #UserFees

NEW: “FDA Matters: Short Takes & Updates—Feb. 20, 2025” at www.fdamatters.com: four threats to FDA’s mission. About FDA lay-offs “If Being Mission-Critical Isn’t Important Enough, What Is?” ------------------------------- #FDA #FDAMatters #TheGrossmanFDAReport #FDAbudget #FDApolicy #RIF

See today's edition of FDA Matters: “If Being Mission-Critical Is Not Important Enough, What Is?” at fdamatters.com/blog! Today’s column looks at the lay-offs of FDA probationary employees over the holiday weekend. #FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAregulations #FDARIF

See today’s FDA Matters’ “Short Takes and Updates” at www.fdamatters.com! It looks at the future of FDA user fees…and updates my column on FDA and budget reconciliation. #FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDAregulations #FDAuserFees #BudgetReconciliation