Abortion pill ruling opens door to more political pressure on medical regulators

Amna Nawaz:

The country is closely watching how the battle over abortion medication unfolds in federal courts later this week. That follows a decision by a federal judge in Texas to overturn the FDA's longstanding approval of the abortion medication mifepristone.

But there's also concerned about what that ruling could mean for the drug approval process in general.

To talk about what's at stake, I'm joined by Dr. Joshua Sharfstein. He's a professor at Johns Hopkins Bloomberg School of Public Health and former principal deputy commissioner of the Food and Drug Administration.

Dr. Sharfstein, welcome, and thanks for joining us.

You wrote in an op-ed for The New York Times you found the Texas judge's decision shocking, stunning and irresponsible. Tell us why that is.

Dr. Joshua Sharfstein, Johns Hopkins Bloomberg School of Public Health: Well, this is a medication that's been on the market for more than 20 years. It's been used by hundreds of thousands of people.

It has the full support of all the medical — major medical professional societies. It's an established part of medicine. And out of the blue, a judge just says: I think the FDA got it wrong. It has to come off the market.

And if that kind of activity is going to happen in the courts, it really throws up in the air why we have an FDA at all.

Amna Nawaz:

Just for context, have you ever heard of a case in which a court invalidated an agency drug approval?

Dr. Joshua Sharfstein:

I am not aware of any case.

And, again, this isn't just any approval. This is one where there was a huge body of evidence, where all the external advisers, those committees voted in favor of approval. And it's a medication that's been used for 20 years with the full support of the medical profession. So this is just stunning, however you look at it.

Amna Nawaz:

Now, the issue of politics making its way into the FDA's work and court battles is not new. You cite the example of the Plan B emergency medication or the contraception being available over the counter about 10 or so years ago to teenagers.

How is this issue, though, over abortion medication different than that battle?

Dr. Joshua Sharfstein:

Well, what the Food, Drug, and Cosmetic Act says is that the FDA should make its decisions based on substantial evidence.

And there are a lot of great scientists, experts, doctors, epidemiologists at FDA who look at the data, and they make a great decision, the best that they can possibly make. Sometimes — but what we don't want is for that decision to be interfered with for political reasons.

What we see now is that interference is coming from the courts. Previously, that interference was coming from the White House. And whether it's the White House or the courts, what the American people deserve, what Congress intended in passing the Food, Drug, and Cosmetic Act is for these decisions to be made on the basis of evidence and science, and not a momentary political calculation.

Amna Nawaz:

There are among the agency's critics, as you know, people who aren't necessarily political actors, right? There are some advocacy groups who have criticized the FDA in the past, saying the agency moves too slowly on some drug approvals, say, for example, on ALS.

Does this open the door for more of those groups to have a different kind of impact, more of an impact on the FDA?

Dr. Joshua Sharfstein:

You know, I think this opens the door to chaos.

I think it's really important for people to be engaged with the FDA and working with the FDA and the scientists at the FDA to improve the work the agency does. But what we don't want are judges just waking up in the morning and making a decision to completely change what the FDA has done, really with no reason, no compelling reason to do that.

And that's a danger, because the FDA is in court all the time. It could be a competitor suing about a decision that FDA makes. It could be an advocacy group on one side or the other. It could be a state legislature that decides, you know, we think we can make the decisions with — about all this evidence.

And once you start chipping away at the idea that we should have good, science-based decisions for what medications we put in our body, then it's really hard to find what the end point is, because there can be a lot of chaos.

Amna Nawaz:

In the minute or so we have left, we are still waiting, of course, to see how the appeals court will take up this case. It will likely end up before the Supreme Court.

You have said the Supreme Court will now have to decide which side it is on. What did you mean by that?

Dr. Joshua Sharfstein:

Well, I really think this is a pretty simple question. Either we are going to allow FDA to do its work, the work that Congress intended the agency to do, to use science to look through, to evidence to make decisions that really matter for all of us as patients, or we're going to say, you know, a judge can come in and change that.

If that if that upends that that's going to change the calculation for companies, which is why hundreds of chief executive officers are saying that they're very worried about what the court might do. And so the Supreme Court has to decide, is it going to support an orderly, smart approach to looking at evidence and making good decisions, or are they just going to say, anything goes?

Amna Nawaz:

That is Dr. Joshua Sharfstein from Johns Hopkins Bloomberg School of Public Health joining us tonight.

Dr. Sharfstein, thank you for your time.

Dr. Joshua Sharfstein:

Thank you.