When the Food and Drug Administration lifted some — but not all — of its restrictions on an abortion pill this week, it raised questions about why these rules were there in the first place. Mifepristone, the drug in question, has been used by over 3.7 million Americans to end early pregnancies since its approval in 2000, is more than 97% effective, tends to have only mild side effects such as cramping, with severe ones occurring in fewer than 0.5% of patients. So why was it on a list of prescription drugs requiring extra precautions and red tape, alongside opioid painkillers?
Those restrictions have been loosening, albeit slowly. During the pandemic, the FDA stopped requiring that mifepristone be prescribed in-person, a change that was subsequently made permanent. But before this week, patients in states where abortion is legal could only get prescriptions from certified providers — a family doctor’s office wouldn’t do — and the order could only be filled by that provider, or by one of two mail-order pharmacies. On Tuesday, the FDA changed the rules again, widening the number of pharmacies that could dispense the drug to include both big chains like CVS and Walgreens, as well as small independent businesses, on the condition that they apply for certification.
Those who first imposed restrictions on the drug expected the rules would be revised as more data emerged. “It’s taken longer, quite frankly, than I thought it would,” said Jane Henney, who was the FDA commissioner in 2000, when mifepristone was approved.
Walgreens and CVS have both said they plan to apply for certification. Many reproductive rights advocates celebrated the change. But to others, the agency hadn’t gone far enough. Having the drug on a list of medicines that require a risk mitigation strategy gives the false impression that it’s dangerous, they argue. To them, it should be treated like any other pharmaceutical that’s been proven safe and effective. That might help ensure as much access as possible at a time when some states have banned it, and many patients have to rely on prescribers and distributors, such as Aid Access, which operate outside of the regulated American health care system to get around state restrictions.
STAT spoke with Henney about the origin of the restrictions and the FDA’s recent move. This interview has been edited and condensed for length and clarity.
What do you think about the FDA’s change to the restrictions on which pharmacies can dispense mifepristone?
I was quite glad to hear it. We wrote a New England Journal article [in 2019], and basically what we called for there was another evaluation by the FDA, to see if a change could be allowed to have greater distribution. I’m delighted with their recent review, that they found a safety profile such that they could comfortably say that it could be distributed without some of the restrictions. As I understand it, a few still stay. But having it available with a prescription through a wider range of pharmacies is really a step in the right direction. And I must say when we approved the drug and limited distribution, we always thought that as there was more experience with mifepristone and misoprostol [a second drug used in combination with mifepristone to end a pregnancy] that, at some point, some of those distribution restrictions would be able to be lifted, if that’s what the data showed.
Do you wish the FDA had lifted all the restrictions entirely, so that mifepristone could be prescribed and distributed like any other drug that’s been proven safe and effective?
They have all the data and can make those judgments. I think, at some point, it may come to that.
You’ve written that the FDA initially imposed restrictions on mifepristone not only because the agency wanted to see more data on safety and efficacy, but also because the data that existed at the time came from a place where health care is very different from the American system. Can you tell me a bit more about that?
At the point that we reviewed and approved this drug in 2000, the majority of the data was from European countries, particularly France. And France has a national health care system where people have easier access to clinical facilities and physicians. So they had a stronger way to track patients, in terms of follow-up about any complications, those kind of things.
We really felt the data was quite solid. But because their system was so different than ours, we put some of the distribution restrictions on the product, clearly with the anticipation that over time, if the safety profile was such that this could be handled in a different way, some of those restrictions might change.
To what extent was the political controversy that surrounds abortion part of the discussion back in 2000 when the FDA was considering approval for mifepristone?
Actually, that wasn’t a consideration as we looked at this product. In fact, I had a conversation with the secretary [of the Department of Health and Human Services] at the time that we were reviewing this, and basically said, we don’t need any interference or help. This ought to be decided on the science and it ought to be done just like we do for any other product. And that’s what I told the reviewing staff: That they should review this drug as they would any other and when they were confident and convinced of their decision, I’d stand by whatever their review was.
How much do you think politics has played a role in the regulation of mifepristone since then?
There’s been a lot of political commentary. I think this is really a decision that a woman should be making with her physician in terms of whether or not this is the means she uses to terminate a pregnancy. When it comes to the FDA, and its own decision-making, it should be looking at the clinical data, the safety and efficacy of a product, and trying to keep the other things at bay. Having politics involved in any decision that the agency makes really goes against what the regulatory agency is supposed to be doing.
Is that what you’ve seen, that the agency has been making decisions based on data?
Yes. For this product while I was there — and I think every time it’s been reviewed that has likely been the case, that they’re reviewing data, they’re not reviewing this based on politics.