Six Causes Championed by FDA Matters
FDA Matters doesn't cover the news....we provide analysis of what's behind the news
The goal of FDA Matters is to analyze FDA policy and regulatory issues and advocate for a more effective, more efficient, and fairer FDA. In support of the agency, I have spent years as an analyst and advocate. I have no intention of stopping now.
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When I launched FDA Matters on January 10th of this year, I started with some topics to analyze, but no sense of which subjects represented my advocacy priorities. That turned out to be a good thing--since the new Administration brought so many new issues to the fore, ones that would not have been on my list at the start of 2025.
Nearly fifty columns later, I see that patterns have emerged--certain topics on which I have dug deeper and spoken more forcefully. While there is room for additions to the list, here are my top six priorities at this time:
1. FDA Is Under Multiple Challenges to Its Authority and Must Act to Preserve Its Ability to Protect Consumers. Mass compounding of drug products threatens the public by usurping the FDA’s responsibilities for manufacturing, distribution, and marketing (A Dangerous Idea: Two Manufacturing Pathways, One Regulated, One Not; A Dangerous Idea Revisited).
On two other fronts: a/ Montana is trying to create a haven for doctors to treat patients with unapproved and experimental drugs (here; Short Takes and Updates August 8 2025 ); and b/ the lack of strong central policy direction at the federal level is opening the door for 50 states to create 50 different food regulatory systems. There are more challenges coming soon and I will write about those in future columns.
2. FDA’s Inspections and Enforcement Responsibilities are Going to Grow Massively in the Near Future and These Programs Need Far More Policy, Programming, and Budgetary Attention Than They Have Been Getting. Among other things, massive budget cuts in Medicaid, SNAP, and other feeding programs will result in more adulterated and counterfeit food and medical products (FDA in a Post-Reconciliation World and here).
This is one of many good reasons that MAHA’s focus on ingredients should not come at the expense of urgent support for food safety inspections and enforcement (see my most recent column on this topic here).
3. Enhancing Public Trust in FDA’s Integrity. The agency has two primary strengths--its expertise and its credibility. Those qualities are being undermined. When FDA is not transparent; doesn’t welcome public input; and advances positions that are off-point or wrong, credibility is lost and will be difficult to reclaim.
With the upcoming user fee cycle, there will be voices opposing the program because they allege it gives FDA too much control over agency decisions. That isn’t true, but it is just as dangerous if policymakers and the public believe it is true. Various columns have covered these issues, including Alice, Humpty-Dumpty and the New Administration, Picking Apart the Claim that Industry Controls FDA, and FDA and Politics: An Unhealthy Combination.
4. FDA Must Support Innovation as Part of Our National Investment in Life Sciences. We Abandon This At Our Peril. Other nations will jump in to fill the void. FDA Matters believes we have a collective responsibility to invest in policies that will drive growth and prosperity in the United States--now and in the future. FDA needs to carry out its mission-driven and statutorily mandated responsibilities as an investment in that future (Elon Musk and the Future of Government Investment in Our Nation’s Future).
5. AI will be Transformative for Nearly Every Part of FDA. The Agency Needs to Work Through Step-By-Step Integration Rather than All-At-Once by Fiat. The Skeptical Enthusiasts Guide to AI at FDA explores the incredible upside for the agency and urges more validation of AI systems. This will require significant human oversight at the beginning and expertise in the specific niche that is being validated.
6. New Agenda Needed for Addressing Chronic Progressive Diseases at FDA. Every day, we are failing patients with chronic progressive neurological, neuromuscular, and genetic diseases, by not investing more in developing better tools to evaluate therapies for their condition and considering alternative pathways for availability of therapies. FDA Matters covered this in Needed: A National Agenda for Advancing Therapies for Chronic Progressive Diseases.
The new Administration has made wholesale changes in the size, philosophy, and goals of government. FDA has not been spared. Some of its former leading advocates have even gone as far as saying that the agency is doomed.
I share their frustration with--and opposition to--many of the new policies and procedures. I doubt the agency will ever be the same---it may be better, worse, or simply different in the future.
In one of my most widely reprinted columns, I laid out the case for why All of Us Need to be Rooting for FDA. It is a realistic analysis of the agency’s situation and offers reasons to be pragmatic. My impression is that a lot of readers approached the column skeptically and came away seeing the good sense in my approach.
Being realistic and pragmatic doesn’t mean giving up on your beliefs. I will continue to write about obstacles to the agency’s success....and I will not hold back on my advocacy for these six causes.