CEO and Co-Founder of Aitia, Developer of AI-Powered Clinical Trials
President at the Center for Science in the Public Interest; Former Associate Commissioner at the Food and Drug Administration
Here is what we have in store this week:
• This week’s debate on whether the FDA should approve safe and effective drugs quicker
• A closer look at the process behind getting a drug FDA-approved
• Your Sunday reading list
On any given day, the famed Food and Drug Administration (FDA) shows up in the headlines. In the past week alone, it’s been the FDA approving the sale of birth control pills without a prescription; the FDA weighing the merits of a new drug to treat Alzheimer’s; the FDA warning a firm marketing stem cell therapies that it’s out of compliance with various rules. That’s just a few examples, and there were many more to choose from.
One of the nation’s oldest regulatory agencies, the FDA is also one of the most visible, established above all to guarantee the safety of medical innovations that will, someday, be inside our bodies. Who can argue with a mission like that, at least in principle? Well, no one, as far as I know, who considers the question reasonably.
But there is disagreement about how the FDA pursues that goal, with complaints that the agency’s standards for efficacy and safety go too far, or are so outdated, that they unnecessarily keep important, innovative medications and devices from reaching patients in as timely a fashion as possible.
From the FDA’s perspective, that’s an unfair perception, given just one recent example where the agency moved along approval most expeditiously: COVID vaccines. In fact, in that case, some complained the FDA went too fast!
Given the multiple angles of controversy, we went ahead and put together a debate that asks this question: Is the FDA Too Cautious? The debater matchup is superb: Peter Lurie, who is a former FDA associate commissioner proud of the agency’s legacy and methods arguing NO, and Colin Hill, the CEO of Aitia who thinks many of those methods are more than ready for an overhaul, arguing YES.
It’s a fascinating look at the tensions between safety and urgency, regulation and innovation. I hope you take a listen!
DEBATING THE DATA
Getting a drug FDA-approved requires many steps to ensure its quality and safety. Would reforming this process maintain rigorous standards?
Is the FDA Too Cautious?
“When it comes to safety, I think the FDA has a level of caution that is about right. When it comes to efficacy, I do not believe that’s the case for a lot of reasons and… the question on the efficacy side is can and should the FDA be doing something differently to allow more of these drugs to come to market to also lower the barrier of entry?”
“[The FDA] has to make these life and death decisions on the drugs that come before it. If it gets new tools, I’m sure they’ll be happy to use them. But for the meantime, what we have are randomized controlled trials that over and over again have proved that they can separate between the effective, the ineffective, the safe, and the unsafe. We have to stick with those until someone can show that there’s a validated or better way to do it.”
WEEKLY POINTS OF VIEW
Here’s The Trump Policy Legacy Biden Is Ending — And The Debate It Should Be Starting
Jonathan Cohn | July 14, 2023
Watch Jonathan’s debate on repealing Obamacare
Human Beings Are Soon Going to Be Eclipsed
David Brooks | July 13, 2023
The New York Times
Watch David’s debate on America’s two-party system
WTH Happened with the Russian Mutiny? Yaroslav Trofimov Unravels the Mystery
Danielle Pletka & Marc Thiessen | July 14, 2023
What the Hell is Going On?
Watch Danielle’s debate on spreading democracy in the Middle East and Marc’s debate on treating terrorists like enemy combatants
Don’t Let Your Pride Get in the Way of Our Arms Sales, Jack!
Matthew Hoh | July 14, 2023
Watch Matthew’s debate on Afghanistan as a lost cause