Dr. Holly Fernandez Lynch

And it's more likely that somebody who had more freedom and flexibility with their investigators would say, well, we know the regulations don't require you to do this, but we think ethical judgment does require you to go a bit above and beyond.

That's the kind of difference that we're talking about here.

It's quite nuanced and very...

very difficult to kind of study IRBs side by side, which is a problem.

These entities should be much more transparent given the power that they have to decide what research proceeds.

Well, the statutory standard remains the same, right?

I feel like a bit of a broken record, but the statutory standard is so simple, right?

Is the drug safe and effective for its intended use?

The sorts of things that have changed at FDA in the past year or so have to do with a couple of things.

One is how quickly is FDA engaging in its review?

A major change under this administration has been a program called the Commissioner's Priority Review Vouchers, in which FDA could grant to companies a voucher in which they promised to review the application in only two months.

rather than six.

And you might think, you know, four months, that's not that big of a deal.

It's a huge deal to companies, right?

Four months longer on the market of a blockbuster drug is a lot of money and four months fewer to review an application for FDA staff.

is really, really challenging.

And it's important to recognize how FDA engages in its review.

They don't just take the company's word for it.

They get all of the data that's supporting that product, all the clinical trial data.

The FDA is running its own analyses of those data, really checking that every T is crossed, every I is dotted, so that we can trust the products that are allowed on the market.