<img src = "https://media.npr.org/assets/img/2018/11/13/mifepristone-2_sq-1ea5573128a2f059a11038bf3b62158837e22e12-s100-c15.jpg" data-original = "https: // media .npr.org / assets / img / 2018/11/13 / mifepristone-2_sq-1ea5573128a2f059a11038bf3b62158837e22e12-s100.jpg "class =" img lazyOnLoad "alt =" Abortion-friendly medicine is difficult for women  to get3939 I think the FDA has been willing … to take action, "Henny says." I believe it's important for them to do another review in light of the safety information we know about this drug. "
NPR talks with Henny about the history of the limitations of this medicine and why he thinks it's time for a new approach.
Interview edited for clarity and brevity
What prompted the decision to limit mifepristone in 2000? The drug was approved The clinical data reviewed by the FDA at this time was largely from experience in Europe, especially in France where they were used. And since there was not so much experience [in the U.S] in using the product, restrictions were put in place so that we could provide it and at the same time monitor what would happen next [in terms of] the risk of surgical abortion, side effects or adverse effects
What has happened during these 19 years is that we have learned a lot about this medicine and that its side effects are relatively minimal and can be handled well. Sometimes there are adverse effects, just like any other prescription drug. But placing him in this restricted distribution does not seem to be from the information we at least know now [necessary]. And it's actually quite burdensome.
How have these initial restrictions changed?
What can be the impact on women in removing some of these restrictions?
The current restrictions place a heavy burden on women who need to go to the clinic and [on] a certified physician. If some of these restrictions have been removed, it is possible to see your doctor who can prescribe you so you can fill up at your pharmacy and take this medicine home right now. Women, especially in rural areas and suburbs, have to go long distances for this and it is just a real burden for them. It is also a burden for doctors to register and keep extensive records.
I think these restrictions on the distribution of mifepristone here may make women search for these products online. And that's where the real risk lies. There is no way for her to be sure that they have the same safety or quality profile and there is a real risk that the product she would receive has an even higher risk profile or may be a product that is not effective at all and will not it works.
If the current restrictions are revised, what can be changed? Well, it will really depend on how the FDA reviews this and what changes they would be willing to make. You could imagine that it would be left everywhere to leave this system in place to make it much more like any prescription drug for which doctors can write a prescription and have it filled by a pharmacist . There are many other products currently in the REMS category. [For] More than half, I would say, all that is required is for the patient to receive a medication guide. Mifepristone has almost the most restrictive distribution system for these products. The FDA, after reviewing all available data, is in a position to decide whether mifepristone should really be so severely restricted at this point.
What would you say to people who claim that mifepristone carries the risk of serious complications for some women and should therefore remain tightly regulated?
I would simply say that like many prescription drugs, there are risks. But the risks of mifepristone are well known and are still prescribed. So the doctor should prescribe the medication and he has a black box warning to make sure the doctor informs the patient of the risks, which are quite rare. These may include severe bleeding, abdominal pain or fever. And if the patient experiences this, he goes back and contacts his doctor for further treatment. I would also say that the risk of medical miscarriage with mifepristone is far less than surgical abortion and far less than women who have died from pregnancy. So I think we are talking about serious adverse events that may occur. They are extremely rare; they are well known and treatable.
Some also claim that abortion can cause lasting emotional trauma and that medication regulations can protect women – how about that?
I would say that women make a serious choice whether to have an abortion or not. And I think one has to weigh the serious consequences of carrying a pregnancy to the term and trauma that often comes with it, to the psychological experience that some patients may have. But I think most women take this decision quite seriously. They often do this in consultation with their doctor. And I think it offers them the opportunity to do what they know best.
Louise Torres is a contributor to the AAAS Mass Media at the NPR Science Office. She is on Twitter at @luisatorresduq .