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fdamatters.bsky.social
@fdamatters.bsky.social
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fdamatters.bsky.social
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
“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...
www.fdamatters.com
June 25, 2025 at 12:34 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
June 16, 2025 at 3:01 PM
fdamatters.bsky.social
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...
Elon Musk and the Future of Government Investment in Our Nation’s Future — FDA Matters
Elon Musk thought cutting government programs was about deficit reduction. When the “One Big Beautiful Bill” reconciliation legislation passed the House with a $3 trillion price tag, he realized he ha...
www.fdamatters.com
June 10, 2025 at 12:55 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
June 6, 2025 at 4:54 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
June 3, 2025 at 2:05 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 28, 2025 at 8:23 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 22, 2025 at 1:05 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 20, 2025 at 3:09 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 15, 2025 at 1:26 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 12, 2025 at 2:51 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 8, 2025 at 3:33 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
May 2, 2025 at 5:07 PM
fdamatters.bsky.social
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
The American People in the Hands of an Indifferent Government — FDA Matters
www.fdamatters.com
April 29, 2025 at 8:33 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
April 22, 2025 at 5:32 PM
fdamatters.bsky.social
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
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 ...
www.fdamatters.com
April 17, 2025 at 5:05 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
April 15, 2025 at 5:09 PM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
April 11, 2025 at 5:55 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
April 7, 2025 at 9:31 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
April 7, 2025 at 9:31 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
April 4, 2025 at 12:55 PM
fdamatters.bsky.social
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
April 2, 2025 at 5:18 PM
fdamatters.bsky.social
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
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...
www.fdamatters.com
March 29, 2025 at 7:23 PM
fdamatters.bsky.social
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!
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
March 28, 2025 at 4:55 PM
fdamatters.bsky.social
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
FDA Matters
FDA Matters and The Grossman FDA Report — bringing you the latest in FDA News
www.fdamatters.com
March 25, 2025 at 9:24 PM
fdamatters.bsky.social
"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...
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#FDA #FDAMatters#TheGrossmanFDAReport #FDApolicy #trump #FEMA
Planning is a Virtue, But Government Agencies Are Paid to Deliver Results — FDA Matters
The Federal Emergency Management Agency (FEMA) is responsible for helping the American people before, during, and after a disaster. It has vast responsibilities and the unenviable burden of never know...
www.fdamatters.com
March 24, 2025 at 7:12 PM