Dr. Holly Fernandez Lynch

The shorter time that the FDA staffers have to review, the more worried we all should be that maybe something important is going to be missed, either around safety or effectiveness.

And the other thing I'll add that's changed is FDA is a challenging agency, right?

If you think about its role, it's a public health agency.

It needs to be science driven, right?

But it's not exclusively science driven in the sense that

Just because a drug has a positive outcome in its trial, that doesn't necessarily mean that FDA should grant approval, right?

There are judgment calls about approving new drugs.

Because very rarely are you getting such amazing trial results that everyone agrees this is a stupendous, amazing drug and we absolutely should approve it.

So when you have those judgment calls, that can lead to the possibility of political interference.

In previous administrations, it's really just been up to the FDA staff reviewers to decide whether a product should get approval without the political appointees kind of dipping their hands in those approval decisions.

And that was for a very good reason.

Nobody wants to be offered a drug in the doctor's office that they have to question.

Well, does this drug actually work?

And did FDA approve it because the data were good?

Or did FDA approve it because the sponsors were buddies with the FDA commissioner or with the president, right?

It's really important to maintain strong kind of separation between those approval decisions and any political interference.

And we've seen a lot more political interference with this administration than we've seen in the past.