FDA commissioner talks on the review process for drugs

Fri, Nov 17, 2023, 2:56 PM

From weight loss drugs that continue to roll out to research expanding on Alzheimer's treatment, regulators are constantly exercising judgments when reviewing and potentially approving new drugs. Yahoo Finance's Anjalee Khemlani sits down with FDA Commissioner Dr. Robert Califf to discuss the FDA's role in the regulatory process for medical and pharmaceutical products.

"I prefer to call it looking forward rather than looking back. We have very robust clinical trials done to get a drug on the market," Dr. Califf says. "But after that product gets on the market, there's no evidence generation system like what we have in the premarket phase. Yet we have all these questions still on the table that need to be answered."

Dr. Califf emphasizes the importance of follow-up inquiries to confirm the safety of devices or treatments.

Click here to watch the full interview on the Yahoo Finance YouTube page or you can watch this full episode of Yahoo Finance Live here. Additionally, Yahoo Finance will be providing more analysis on the healthcare industry in its week-long special coverage Healthcare: Industry Checkup.

This post was written by Luke Carberry Mogan.

Video Transcript

ANJALEE KHEMLANI: There are definitely new areas of medicine that we are seeing come out.

For example, the weight loss drugs that people are so focused on, Alzheimer's disease drugs, as well as new innovation areas like CRISPR that we've just seen approval for over the pond.

So I just wonder, with all of this going on, how do you think about the need to look back after approvals?

And what is needed to make sure that these medicines are safer for us?

ROBERT CALIFF: Yeah, thanks, that's a great question.

It's good to be with you.

I prefer to call it looking forward rather than looking back.

Because the way our system works.

We have very robust clinical trials that are done to get a drug on the market.

And by the way, I put high-risk devices in the same category where you got to show that your product produces a health benefit that exceeds the risk for a particular population under particular circumstances.

But after that product gets on the market, there is no evidence generation system like what we have in the pre-market phase, and yet we have all these questions that are still on the table that need to be answered.

The weight loss drugs may be the easiest to talk about right now because everyone, I think, recognizes there are so many questions.

Who really should be treated?

Are there subpopulations where the benefits outweigh the risks?

What are the right doses, really out of all the possible doses?

You have to prove you at least have a dose to get on the market, but you don't have to prove you have the best dose at that point.

So many questions left to be answered.

This is not directly in the FDA's regulatory control, and so what we're doing is more saying we need a system to do this.

FDA plays a role, but so do many other parts of the government and the private sector.

ANJALEE KHEMLANI: So who do you need to help make this happen?

And what do you anticipate the pushback could be from companies?

Because this is adding just another layer of administration for them, whether it's sponsoring the trials or sponsoring studies?

And really investing in that follow-up.

ROBERT CALIFF: Well, we got to divide, we got to parse that out a little bit, so first of all, your presumption is that company is going to pay for these post-market studies, and companies certainly do.

But we all know that the metric for a company doing a post-market study is a net present value calculation.

It's not a public health question.

And so, there's a big issue as to whether public funding should be used for some of these studies because the answers are so critical to federal agencies, like CMS, who, after all, have to pay a big part of the the revenue that these companies make.

I'd also say there are some circumstances where FDA does have jurisdiction because there's a safety issue.

And if we look at the-- what's going to be a real amazing increase in gene editing therapies that are about to hit the markets.

We're going to need long-term follow-up in those patients because no one knows what the potential impact of things like off-target effects might be.

So that's a case where the industry does need to pay for it in return for getting the product on the market.

But for a lot of this, it's more of a, we all have a stake in this, and we need to figure out how to put together a system that generates the best evidence.

And don't forget that if you prove that your product is better than the competitors, that's a pretty good market.

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