Newsletter: Is The FDA Too Cautious?

FDA being too Cautious Open to Debate


Colin Hill
CEO and Co-Founder of Aitia, Developer of AI-Powered Clinical Trials


Peter Lurie
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the FDA pursues that goal, with complaints that the agency’s standards for efficacy and safety go too far, or are so outdated, that they unnecessarily keep important, innovative medications and devices from reaching patients in as timely a fashion as possible.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!

John Donvan



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?”

Colin Hill



“[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.”

Peter Lurie




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