Mifepristone is one of a regimen of two drugs approved by the Food and Drug Administration to end an early pregnancy. It's also prescribed to help reduce the severity of miscarriage symptoms. But it is heavily regulated in ways that can make it hard for women to obtain. Along with its approval in 2000, the FDA restricted its use because of safety concerns.
In a perspective article published this summer in the New England Journal of Medicine, former FDA Commissioner Dr. Jane Henney and co-author Dr. Helene Gayle argue that the agency should reevaluate whether such measures are still necessary and take into consideration recent studies that show mifepristone is both effective and safe.
Henney, who was FDA commissioner when the restrictions were imposed, explains that the agency placed mifepristone in its program for risky drugs, Risk Evaluation and Mitigation Strategies. This program includes drugs such as antipsychotic medications and narcotics. Mifepristone is one of the most restricted of all drugs in the REMS program, Henney says.
The FDA mandates that doctors and clinics must be certified to prescribe the drug, and women must go to a clinic, medical office or hospital to obtain it — rather than getting it at a pharmacy. In 2016, the agency partially revised the restrictions to extend the gestational age limit for mifepristone and to eliminate the requirement for an in-person follow-up after taking the drug.
"I think the FDA has shown a willingness to ... take action," Henney says. "I believe it's important for them to do another review in light of the safety information we know about this drug."
NPR spoke with Henney about the history of restrictions on this drug and why she thinks it's time for a new approach.
The interview has been edited for clarity and brevity.
What prompted the decision to restrict mifepristone back in 2000?
We put the restrictions on the distribution system for mifepristone at the time the drug was approved. The clinical data that was reviewed by the FDA at that point was largely from the experience out of Europe, particularly France, where it was used. And since there wasn't that much experience [in the U.S.] using the product, the restrictions were placed so that we could make it available and at the same time monitor what would happen after that [in terms of] risk of surgical abortion, side effects or adverse effects.
What has happened over the course of these 19 years is that we have learned a lot about this drug and that its side effects are reasonably minimal and can be well-handled. There are, on occasion, adverse effects, just like there are with every other prescription drug. But putting it into this restricted distribution doesn't seem, from the information at least that we know now, to be [necessary]. And in fact, it's quite burdensome.
How have those initial restrictions changed?
In 2016, the FDA reviewed their distribution system and the restrictions that had been placed on the drug and did make some changes. It went from seven to 10 weeks of pregnancy in terms of use. It took off the need for the woman to actually take the medication in the doctor's office. But it left in place this whole notion of registering clinics and keeping extensive records. So there was a review of the data at one point by the FDA. We just feel like it's time that it happened again.
What might be the impact on women of lifting some of those restrictions?
The current restrictions impose a lot of burden on women who have to go to a clinic and [on] the certified physician. If some of those restrictions were lifted, you could possibly go to your own physician who might write a prescription that you could get filled in your pharmacy and take this medication at home right now. Women, particularly in rural areas and suburbs, have to travel long distances for this, and it's just a real burden on them to do that. It's also a burden on the physicians, who have to register and keep extensive records.
I think these restrictions on the dispensing of mifepristone here may be driving women to seek these products over the Internet. And there lies a real risk, I believe. There's no way she can be assured that they have the same safety profile or quality, and there is a real risk that either the product she'd receive would have an even higher risk profile, or it also might be a product that is not efficacious at all and won't work.
If the current restrictions were reviewed again, what might change?
Well, that would really be up to how the FDA reviewed this and what changes they would be willing to make. You could imagine that it would be anywhere from leaving this system in place all the way to making this much more like any prescription product which physicians can write a prescription for and it gets filled by a pharmacist. There are many other products that are in the REMS category right now. [For] more than half, I would say, all that is required is that the patient receives a medication guide. Mifepristone has almost the most restrictive distribution system of those products. The FDA, after looking at all the data that is available to them, is in a position to make a decision about whether mifepristone at this point really needs to be so tightly restricted.
What would you say to people who argue that mifepristone does carry risk for serious complications for some women, and that therefore it should remain strictly regulated?
I would just say that like many prescription drugs, there are risks. But the risks with mifepristone are well-known and it's still by prescription. So a doctor has to prescribe the medication and it has a black box warning to make sure that the doctor informs the patient about risks, which the serious ones are quite rare. They could include heavy bleeding, abdominal pain or fever. And if a patient experiences that, they go back and get in touch with their doctor for further treatment. I would also say that the risk of medical abortion with mifepristone is far less than a surgical abortion and far less than women who undergo a death from pregnancy. So I think we're talking about serious adverse events that can occur. They're extremely rare; they are well-known and they are treatable.
Some also argue an abortion can cause lasting emotional trauma, and that regulations on the medication could protect women — what do you say to that?
I would say that women are making a serious choice about whether or not to have abortion. And I think that one has to weigh the serious sequelae of carrying a pregnancy to term and the trauma that often comes with that, versus some psychological experience that some patients may have. But I think that most women make this decision quite seriously. They oftentimes make it in consultation with their physician. And I think that it offers them an opportunity to do what they know best.
Luisa Torres is an AAAS mass media fellow on NPR's science desk. She's on Twitter at@luisatorresduq.
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