#FDAmatters

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8 months ago

“A Dangerous Idea” Revisited — FDA Matters Recently Novo Nordisk dropped out of its arrangement with Hims and Hers because the latter continued to sell compounded GLP-1 weight-loss products that are no longer legal (except in extremely limited...

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

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9 months ago

Alice, Humpty Dumpty, and the New Administration — FDA Matters As children, we are taught that “sticks and stones will break my bones, but words will never hurt me.” That may have helped children develop resilience against verbal bullying, but it totall...

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

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9 months ago

A Dangerous Idea: Two Drug Manufacturing Pathways–One Regulated, One Not — FDA Matters 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 to a large number of their customer...

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

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9 months ago

The Skeptical Enthusiasts Guide to “AI at FDA” — FDA Matters I welcome Commissioner Makary’s embrace of AI and applaud yesterday’s announcement of the next step in agency adoption of AI technology.  I wrote earlier that: “AI can help FDA make better regul...

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

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9 months ago

Non-Defense Discretionary Spending Threatened By Budget Reconciliation Shortfalls — FDA Matters “While discretionary spending is not part of the reconciliation process, some policymakers may point to savings from that category as “offsets” for other policies.” FDA makes significant contributio...

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

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9 months ago

A Dangerous Idea: Two Drug Manufacturing Pathways–One Regulated, One Not — FDA Matters 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 to a large number of their customer...

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

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9 months ago

Finally, Some Encouraging News from FDA — FDA Matters The most important questions facing FDA and the stakeholder community are:  After the lay-offs, RIFs, and voluntary departures, does the FDA have enough staff and expertise to fulfill the agency...

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

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10 months ago

If You Are Not Confused, Then You Are Not Paying Attention: FDA Edition — FDA Matters “Flooding the zone” has worked as a strategy for the Trump Administration, at least so far. We are all so busy reacting to the newest proposals that we don’t have time to address the previous week’s i...

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

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10 months ago

Picking Apart the Destructive Claim That Industry Controls FDA — FDA Matters I am tired of the continued defamation of FDA as an agency controlled by industry.  That is not to say that FDA is perfect or that there have never been FDA-industry interactions that looked (an...

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

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10 months ago

New CBER Leadership: The FDA Matters Analysis — FDA Matters The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story.   Reactions ranged from “Omigod, he’ll destroy the in...

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

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10 months ago

Truth-Telling: FDA User Fee Edition — FDA Matters After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plaus...

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

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10 months ago

The American People in the Hands of an Indifferent Government — FDA Matters

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

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10 months ago

FDA and Politics: An Unhealthy Combination — FDA Matters Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024, I am sure he believed that Trump 2.0 wou...

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

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10 months ago

Leaked FY 26 FDA Budget Document Explained — FDA Matters There is a document widely-circulated this morning that purports to be the OMB passback to HHS of the draft proposed FY 26 HHS President’s budget request. It includes proposed numbers for FDA funding ...

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

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11 months ago

Rx for FDA: An Agenda for the Commissioner — FDA Matters While FDA’s responsibilities have not changed, its capacity to perform its duties has been significantly reduced. After subtracting approximately 4,500 employees  from the agency’s 19,000 employe...

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...

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

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11 months ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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

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

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11 months ago

The Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking — FDA Matters Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” ( here ). Alec has a well-deserved reputation as one of the best FDA analysts. Alec t...

The latest from The Grossman FDA Report:
The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking

www.fdamatters.com/fdamatters/t...

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts

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11 months ago

The Possible Demise of User Fees: Existential Threats Require Outside-the-Box Thinking — FDA Matters Last Thursday, Alec Gaffney of AgencyIQ declared “…the future of FDA’s user fee programs is in extreme jeopardy” ( here ). Alec has a well-deserved reputation as one of the best FDA analysts. Alec t...

The latest from The Grossman FDA Report:
The Possible Demise of User Fees: Existential Threats Demand Fresh Thinking

www.fdamatters.com/fdamatters/t...

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #userfees #medicalproducts

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11 months ago

New Administration’s Food Priorities Require Resources, Expertise, and Regulations:Where Will They Come From? — FDA Matters First appeared in Food Safety News . Reprinted with permission. ------------------------------ Se cretary Kennedy’ announcement ca me last Thursday : FDA’s contribution to the pending HHS reduct...

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...
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #FDArif #rif #rfkjr #maha

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11 months ago

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

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11 months ago

You are Entitled to Your Own Opinions, But Not to Your Own Facts — FDA Matters If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health  to keep fighting? My answer would be Dr. Peter Marks. I know you would agre...

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

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11 months ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #federalworkers #govtdownsize

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11 months ago

Your Brother-In-law Keeps Asking: What Is Happening to Federal Workers at FDA? — FDA Matters The Federal Workforce is Large….FDA’s Is Small But Important Deficit Reduction Will Reduce the Federal Workforce….FDA Is Affected But Not Specifically Targeted President Clinton Significantl...

What Is Happening to FDA Employees? An Analogy Can Help
Read about it here: www.fdamatters.com/fdamatters/y...

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #federalworkers #rfkjr #deficitreduction

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11 months ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #maha #rfkjr #foodpolicy #healthyeating

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1 year ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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

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1 year ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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

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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy #trump #AmericasBloodCenters

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1 year ago

FDA Matters FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News

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
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#FDA #FDAMatters #TheGrossmanFDAReport #FDApolicy

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1 year ago

Subscribe to The Grossman FDA Report — FDA Matters Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.

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.
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAMakaryConfirmation #FDAGottlieb #FDApolicy

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1 year ago

Subscribe to The Grossman FDA Report — FDA Matters Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.

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
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAregulations #FDApolicy #healthspan

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1 year ago

Subscribe to The Grossman FDA Report — FDA Matters Get the latest updates on the FDA from The Grossman FDA Report, brought to you by Steven Grossman.

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
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#FDA #FDAMatters #TheGrossmanFDAReport #FDAreform #FDApolicy #FDAlayoffs

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