Houman David Hemmati, Co-Founder and Chief Medical Officer of Optigo Biotherapeutics and Levation Pharma, shared a post on X:
“The FDA Commissioner role is open. This is a pivotal moment for American medicine – and for American patients.
Here’s what I believe the next Commissioner should stand for. Not as a wish list. As a baseline.
1. Bring back the Advisory Committee – and make them count.
Advisory Committee meetings are one of the FDA’s most powerful tools for transparency. They should return in full force. Open. Public. And real.
Patients, doctors, scientists, advocates, and skeptics should all be able to speak. But if you want to speak, you fill out a financial conflict-of-interest form under penalty of perjury – and you read it out loud at the podium before you say another word. Every single person.
And if the issues are complex and the science requires more than one day, then take the time. Don’t cut people off because the schedule says so. The public deserves to see exactly how these decisions are made. Real transparency builds real trust.
2. Stop asking only ‘is it safe enough to approve?’ – start asking ‘what happens if we don’t?’
For rare diseases. For serious conditions with no good options. For patients who don’t have ten years to wait for traditional trials that may never be feasible.
Every regulatory decision carries two risks: the risk of approving something, and the risk of not approving it. Both are real. Both affect real people.
When traditional gold-standard trials aren’t practical, we should still be able to move with urgency – but only when paired with strong post-approval commitments and rigorous safety monitoring. We can give desperate patients a chance without abandoning scientific integrity.
3. The FDA’s only client is the American patient. Full stop.
The FDA exists to serve patients – not outside interests or external pressures of any kind.
It must continue protecting the public from products that carry real, known risks but offer no meaningful clinical benefit.
At the same time, when there is credible evidence that a treatment can help patients with serious conditions, Americans and their physicians should be trusted to make informed decisions once they have complete and honest information about the risks, benefits, and alternatives.
The FDA’s job is to make sure the science is sound and the information is clear. Then let patients and doctors do what’s best for them.
These principles matter because the FDA’s decisions affect every family in this country.
Note: This is a simple social media post and not a massive policy document. The issues are FAR more nuanced, there are challenges and risks with each of the things I said above, and I recognize that. But it’s intended to serve as a discussion starter. We must always strive to improve, and we can when we have open debate and dialogue.
Further thoughts:
I’ve spent my entire career working on some of the most complex areas in medicine: cell and gene therapy, rare diseases, cancer, stem cells, nano-robotics, and more common conditions like macular degeneration and myopia.
Over the decades, I’ve watched something striking happen again and again: regulatory agencies all over the world try to copy what the FDA does. Whether it’s in Europe, Asia, or the Middle East, the gold standard they all chase is still the U.S. FDA. That didn’t happen by accident.
As we approach America’s 250th anniversary, I keep asking myself a bigger question: What should the FDA do now so that 250 years from now, it’s still the global leader in protecting patients while advancing medicine?
We are about to enter a completely different era. Gene editing, artificial intelligence, nanotechnology, and stem cell science are moving so fast that we will soon have therapies and medical devices that most of us can’t even imagine today. That’s exciting – but it also means we’re going to face scientific, clinical, and ethical challenges we’ve never dealt with before.
- How do we evaluate therapies that introduce non-human genes – or entirely new genes – into human beings?
- What happens when scientists perfect the ability to create eggs and sperm from skin cells?
- How do we regulate highly individualized therapies that could fix multiple genetic defects in one patient at the same time?
These aren’t science fiction scenarios. They’re coming. And we need a regulatory system that is smart enough, flexible enough, and courageous enough to handle them – without defaulting to ‘no’ just because something feels new or uncomfortable.
I’ve seen too many promising treatments for desperate patients get slowed down or blocked by rigid, outdated thinking. That approach doesn’t protect patients in the long run. It harms them. And if America gets this wrong, we won’t just lose patients – we’ll lose our edge in medical innovation to places like China that are moving aggressively.
The FDA has an incredible legacy. But legacy alone won’t carry us through the next 250 years. We need to modernize how we think about risk, benefit, and progress – while never losing sight of our core mission: protecting American patients with rigorous science and clear information.
This is the moment to get it right. Not by being reckless, and not by being afraid – but by being thoughtful, forward-looking, and unapologetically focused on what’s best for the American people.”
Other articles about FDA on OncoDaily.