Twenty years ago today, the Food and Drug Administration approved mifepristone, a drug used to terminate early pregnancies that held the promise of revolutionizing abortion care in the U.S.
Colloquially called the abortion pill, mifepristone is taken in combination with another drug, misoprostol, and allows patients under 10 weeks pregnant to have an abortion in the privacy of their home, instead of inside an abortion clinic. Reproductive rights activists lobbying for the drug envisioned a future where women could have the pills prescribed by their primary physician and dispensed at their local pharmacy, transforming abortion into just another part of normal health care.
And yet, in the year 2020, that vision has not come true.
Rigorous research has shown that medication abortion is safe and effective, and over 3.7 million women have used it to end their pregnancies since its approval. These days, about 40% of abortions in the U.S. are done using medication. Still, mifepristone is still treated as a dangerous drug, over the objections of a growing chorus of medical organizations and Democratic lawmakers.
Because mifepristone is subject to a special set of FDA restrictions known as a Risk Evaluation and Mitigation Strategy (REMS), medication abortion is highly regulated. In most cases, patients seeking the drugs must drive to their closest abortion clinic, which may be hours away depending on the state, to get the medicines.
The coronavirus pandemic has brought into stark relief the consequences of the restrictions. Patients have been forced to travel long distances in violation of stay-at-home orders to obtain drugs that could easily be sent in the mail.
In May, reproductive health care providers successfully sued the FDA to temporarily block the requirement that patients obtain medication abortion in-person during the pandemic. Currently, patients in some states are able to access medication abortion via telemedicine, though the Trump administration has asked the Supreme Court to block the lower court ruling. At the same time, some anti-abortion rights Republican lawmakers, such as Sen. Ted Cruz of Texas, are pushing to have the drug removed from the market entirely.
To understand the history of medication abortion in the U.S., HuffPost spoke to Cynthia A. Pearson, executive director of the National Women’s Health Network, who campaigned for the abortion pill to be approved in the 1990s.
You testified at the FDA meeting in 1996 where an advisory committee recommended the approval of medication abortion. What do you remember from that day?
At the time, I was the policy advocacy director for my organization and I had been campaigning to get the pill to the U.S. for several years. The most visceral memory I have is the fear that the FDA staff felt about violence. I had been going to FDA meetings on all kinds of women’s health issues for years. Usually we would take the subway, walk through a parking lot, enter the FDA building and take the elevator down to a basement area to their conference rooms. It would be just another government meeting.
This meeting was in a different, secured location. They were so concerned about safety that all of us who wanted to go to the meeting had to first park at a hotel and get screened before getting on the shuttle bus. Then we had to go through another set of federal marshals and get screened again before we could get into the room where the meeting was held. The FDA’s fear of violence wasn’t unjustified. There had been violent attacks against abortion providers and threats made against FDA officials. FDA spokespeople at that time were counseled not to use their names for fear of becoming targets. We knew we were going into this really fraught situation.
At the time the committee voted in favor, I remember thinking, “We did it! We did it!” My heart raced. But then, almost immediately, things started to go off the rails. They started talking about restricting it to only doctors who already provide abortion, which undermines the whole idea of it becoming more available. The idea was that it could be prescribed by any physician.
It took four years to finally get approved, and once it was, medication abortion was subject to a whole host of restrictions. What did you think when that happened?
By that time, mifepristone had been approved in dozens of countries, used by millions of women and the safety record was already well known.
I thought the restrictions would be gone in a couple of years. When I was talking with our contacts inside the FDA in 1996, the message was: Let’s keep it with trained abortion doctors right at the beginning and then there’ll be no complications, and then it’ll be okay to loosen the rules and let any doctor prescribe it because we’ll have it established that it’s safe.
It was really short-sighted, the idea that avoiding complications would avoid a political backlash. There was always going to be a political backlash! People who oppose abortion oppose any kind of abortion, safe or not. They believe it’s wrong. It was a misguided strategy.
In 2007, when the REMS program was begun, mifepristone was added to the list of drugs requiring special oversight. What impact did that have?
If the original approval was an ankle bracelet, REMS was the prison. Nothing ever gets out of REMS. As a longtime women’s health activist, I’m not aware of any drug that has gotten out of REMS once it’s been put in, because it’s designed for dangerous drugs.
REMS is not a bad program. It’s designed for drugs that have proven efficacy but have some pretty serious dangers. So guidance is needed to maximize the risk-benefit ratio. But mifepristone is not a dangerous drug.
How does it make you feel, seeing medication abortion still regulated in such a strict way, after 20 years of evidence on its safety?
It’s completely wrong. It’s medically unjustifiable and politically motivated and has been for 20 years. I have some empathy for people in the FDA who are buffeted by political stresses and strains and anti-abortion legislators. I understand that they get a lot of pressure. But in the end, we need them to do their job, and their job is to be honest about the drugs they regulate, regardless of whether it’s a vaccine, whether it’s abortion care whether it’s chemotherapy, whether it’s obesity drugs. In this case, they’re not being intellectually honest with the world about the safety of the use of medication abortion.
Tell me about your recent campaign to end the REMS on medication abortion.
About a week after we all went home due to coronavirus, we started wondering, how are women going to get to the clinic? Dammit, we should just tell the FDA, they need to drop the REMS. Early in April we wrote a letter to the FDA commissioner signed by 83 organizations saying, drop it, drop it right now, drop it in a hurry because it’s urgent, and drop it forever because it’s a settled question, it is not needed to protect the safety of pregnant patients.
I got no response, not even an acknowledgment that I sent the letter. I then asked for a meeting; no acknowledgment that I asked for a meeting.
I’ve interacted with multiple commissioners appointed by Republicans and Democrats, and I’ve never, ever in all these years had an FDA commissioner’s office not even acknowledge that I sent a message or request for a meeting.
We hope there will be a shift in the political climate that makes it clear to the FDA that they will be free to go by the science and their actions will be understood as being science-based. They might get political criticism, but they won’t be stopped or have their budget cut or leader muzzled or something like that. If I wasn’t optimistic, I wouldn’t have stayed working in women’s health over 30 years. I’m not optimistic about the coming days. But I’m still optimistic about eventually getting the abortion pill out of these restrictions.
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