In 1992, when I arrived at the Rayburn House Office Building to serve as a summer intern for then-Oregon Rep. Ron Wyden, the Democrat’s office was feverishly preparing for a congressional hearing on a drug called “RU-486.” The actress Cybil Shepherd testified, drawing attention to the proceedings, and we pored over data regarding the safety and efficacy of the drug we now know as mifepristone. At the time, mifepristone was only available in France, but the experience from that country had already demonstrated that the drug was effective, as safe or safer than surgical abortion — and much more affordable.
Mifepristone became legal in the U.S. in 2000, and its availability dramatically shifted the majority of early abortions to a medication-induced process that occurs in the privacy of one’s home.
Mifepristone became legal in the U.S. in 2000, and its availability dramatically shifted the majority of early abortions to a medication-induced process that occurs in the privacy of one’s home. It is used in conjunction with another medication, misoprostol, which prompts the contractions that complete the abortion. Twenty years of post-marketing data across more than 3 million usages for unwanted pregnancy has only strengthened the positive medical reputation of this drug combination.
On Friday in Texas, U.S. District Judge Matthew Kacsmaryk ruled that the FDA’s initial approval of mifepristone was unlawful. The plaintiffs, a collection of anti-abortion groups calling itself the Alliance for Hippocratic Medicine, had argued that the medication poses an unusual danger to the patient having an abortion. The plaintiffs expressed concern that the drug causes side effects, including cramping, bleeding and pain, that patients who use it experience regret and mental health sequelae, and that doctors who oppose abortion should not have to treat any complications that occur.
When Kacsmaryk issued his decision, Dr. Jennifer Lincoln, an ob/gyn and executive director of the reproductive organization Mayday Health, messaged me: “I am unsurprised that a conservative judge does not know more than the doctors and scientists who have known about the safety of this drug for over 20 years.” Indeed: the arguments that mifepristone is dangerous are disingenuous, cherry-picked and absurd.
Cramping pain and bleeding are simply symptoms of losing a pregnancy, whether through abortion or miscarriage. Serious side effects of mifepristone requiring hospitalization or transfusion are extremely rare, occurring at a rate of less than half of a percent across studies. It is safer in many respects than a drug such as Tylenol, which causes hepatotoxicity and yet can be purchased from a vending machine, and much safer than pregnancies carried to term — 1.4% of which result in severe maternal morbidity. Mental health problems are more common among women denied an abortion than those who have one. And treating a complication of any medication, including ones we ourselves do not or would not ourselves prescribe, is called caring for our patients.
A drug’s performance depends not only on its intrinsic properties but also on the context in which it is made available. The safety and effectiveness of an induced abortion is reduced when it is delayed and inaccessible. Anyone actually concerned about mifepristone’s impact on physical or mental health would make the drug easier to access.
In fact, mifepristone has been available only under a “risk evaluation and mitigation strategy” (REMS), something usually deployed early in a drug’s development, when a drug has striking safety risks, or when there is a risk of abuse. Only a certified provider can prescribe it, certified providers must sign an agreement with the patient that health risks have been reviewed before prescribing, and, until recently, the medication could only be dispensed to patients directly within a health care setting.
The American College of Obstetrics and Gynecology (ACOG) opposes these unnecessary and onerous requirements, which limit access and are completely at odds with the evidence base for the drug and the experience of OB-GYNS prescribing these medications. A lawsuit out of Oregon and Washington takes aim at REMS as “unnecessary and burdensome,” urging that mifepristone’s availability be sustained and that it be prescribable without any REMS, “just like the 20,000+ other drugs that don’t have one.” That the mifepristone situation is not about actual safety is highlighted by the fact that Korlym, which is mifepristone at a higher dose but used for Cushing’s syndrome, is not subject to REMS. Canada offers mifepristone like any other prescription medication, without REMS, and has demonstrated similar stable, outstanding safety data.
Anyone actually concerned about mifepristone’s impact on physical or mental health would make the drug easier to access.
Of course, the plaintiffs and judge in the Texas case aren’t really hoping for a better, safer drug regimen for abortion. The plaintiffs are against abortion and filed the case before a Trump appointee who previously worked for a Christian conservative legal group. Should their personal beliefs be able to dictate a scientific regulatory process or threaten the availability of particular medications, including those well established as within the public good? Such logic could play out across thousands of critical medications that treat conditions vulnerable to judgment and stigma, including sexually transmitted infections, substance use, obesity, smoking-induced lung disease and many cancers, or those used for cosmetic reasons.
Importantly, countries with liberal abortion laws and ready access to reproductive services and medications, including contraception and abortion pills, have fewer abortions and lower maternal death rates. This is particularly germane in the United States, where maternal mortality has risen sharply recently and remains by far the highest among high-income countries. Throwing up further barriers to core services that people across the country need will worsen our global standing in key health outcomes.
In the 1992 hearing on the hill, Shepherd said, “I fear for the health and safety of my children and for the health and safety of all of America’s children. What will happen to them if they need this medication, and it is not available?” The question remains relevant today, but I don’t think we’ll ever be compelled to find out the answer at scale. When manufacturer Roussel Uclaf was pressured to withdraw the medication by anti-abortion groups, French Health Minister Claude Evin reinstated it at the urging of the public and the medical community, stating, “From the moment governmental approval for the drug was granted, RU-486 became the moral property of women, not just the property of the drug company.”
The majority of people in this country support the legality of abortion. Its documented history reaches back to 1500 BC, and society after society has deemed it necessary since. Today, despite the Texas ruling, abortion pills are available in all 50 states. Abortion is an inevitability, rogue Texas judge be damned: The public will continue to claim ever safer and easier options for obtaining abortions, and, once they have them, won’t give them up quietly.
CORRECTION: (April 11, 2023, 4:58 p.m. E.T) A previous version of this article misstated the disease that Korlym, a higher dose of mifepristone, is used to treat. It is Cushing’s syndrome, not Cushing’s disease, a separate disorder.
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