Jerry Avorn, MD
speaker
49 appearances
1 recordings
1 series
first heard May 2025
last heard May 2025
Jerry Avorn, MD’s voice in public audio — every appearance, attributed to the second.
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Appearances
know for me that makes about as much sense as saying well you know the court system is kind of strained so why don't we let all the plaintiffs attorneys or the defendants attorneys pay the judges because that way we'll have enough judges i think you know if the judge is getting paid by one side in the courtroom we all know where that can lead but unfortunately that's the system we've sort of backed into with these user fees that now comprise as i said about 50 of fda salaries
in its drug approval branch. So one thing I would say to the hypothetical person at the FDA is we need to figure out a way that you can actually get enough money from Congress that you can pay your own staff and not rely on user fees from the drug makers that you're supposed to regulate to be able to meet payroll.
Actually, Mike, I don't see it that way at all. I do think of it, although it shouldn't be sort of nasty with people kind of pounding the table, but I think in a very kind of quiet and careful way, a lot of science is sort of adversarial in the sense that you're describing it. And that is, I think the assumption needs to be that when a new drug comes to the FDA,
There's no assumption that it works. There's no assumption that it doesn't work. I think one needs to just say, I don't know if this is a good drug. I don't know if it's a bad drug. I just want to look at all the evidence and let the people who are bringing it forward give me their best shot.
And I, as an FDA reviewer, for example, if I worked at the FDA, I'm going to basically say, that may or may not be true. I want you to convince me. I think that's a very healthy, scientific, gentle way to proceed without any assumptions being made one way or the other. And that's probably the best way to do science.
The way now is that the industry has gotten an enormous amount of influence about these decisions. And the FDA is under a lot of pressure to basically please the industry because that is the side their bread is buttered on. And the industry is always complaining that, oh, FDA is keeping these great drugs away from the American people because they're so sluggish and obstinate.
In fact, when we and others have looked at the data, the FDA is about as fast an approval agency as any in the world. Traditionally, the FDA has been able to turn around a decision within six months of getting, you know, terabytes of data that it reviews very carefully. And I don't think you'd want them to do it too much faster.
Again, I certainly don't want to leave listeners with the sense that most drugs on the market are unsafe or don't work. You know, most drugs on the market are safe and do work. And I guess I just would love it if we could be more scientific about getting it right nearly all the time instead of most of the time.
Thanks, Mike. I've really enjoyed talking with you, and thanks for having me.
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