Medication abortion is on the chopping block today. Tomorrow, it may be contraception.
Where does it go from here? Where does it stop?
The April 7 ruling by a federal judge in Texas forces the Food & Drug Administration (FDA) to revoke its 20+ year approval of mifepristone, one of two drugs used in abortion care that is endorsed by 12 leading medical organizations, including the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG).
Much is at stake. 64.5 million women of reproductive age stand to lose access to a medication that has been approved and in use in the U.S. for 23 years. All at the hands of one judge with the power to reverse a decades-long precedent; ban manufacturers from shipping the drug nationwide, including in states where abortion is less restricted; and set into motion a terrifying domino effect from here. The risks are high and many women will suffer.
Two decades of research among the five million people in the U.S. – and millions more worldwide – who have taken mifepristone for abortion and to manage early miscarriage demonstrates the drug is safe. Risk of complications from medication abortion is less than 0.4 percent. In comparison, 15 percent of users taking Viagra report side effects.
However, this case isn’t about science, nor backed by medical evidence.
This is political. And, for us – as with millions of people nationwide – this is personal.
Mifepristone was developed in 1980, with the FDA issuing testing permits from 1983 through 1989. Clinical trials launched in 1994. By 2000, the FDA approved mifepristone in combination with misoprostol as a safe and effective way to end early pregnancies. Despite the spurious claims that the FDA rushed the drug to market, nothing could be further from the truth. It was years of review before the FDA allowed mifepristone onto the market—far longer than other drugs approved that same year.
Today, mifepristone is approved for use up to the tenth week of pregnancy; to complete an early miscarriage; and to end pregnancy that threatens the life of the pregnant person. It’s prescribed as a treatment for Cushing’s disease, a rare, progressive disorder in which the body produces too much cortisol. And researchers are exploring the contraceptive effects of mifepristone, how mifepristone can help to prevent breast cancer among BRCA1 carriers (a mutation that increases the chance of developing breast cancer by 55-72 percent), in addition to 238 other conditions, including brain and prostate cancers; ovarian and uterine tumors; bipolar disorder; and generalized depression.
It helps to regulate blood pressure and metabolism.
It addresses inflammation and sleep cycles.
The list continues, making one thing clear: the Texas ruling that pulls mifepristone from markets nationwide, systematically dismantles people’s access to a safe, effective, and life-saving medication, and jeopardizes other rights the courts have grounded in personal freedom and privacy, such as the right to contraception.
Everyone who has used or will ever need or use a medication should be alarmed. This is an affront to your access and our collective access to healthcare. What could be next?
Our combined experiences have taught us that what happens in the U.S. affects people everywhere.
As the Global Medical Director and as a Board Member of global health organization Population Services International (PSI), we’ve supported governments across low-and-middle-income countries to open the door for millions of people to access sexual and reproductive health products, services, and information. Across the 40+ countries in which PSI works, and over the past 53+ years, we’ve seen that when people can choose the care they want, they can drive forward their lives. We believe in Consumer Powered Healthcare, where people’s voice, choice and agency lead the way.
That’s why we agree with leading medical associations, like the AMA, and global regulatory bodies, like the United Nations: it is a violation of human rights when government intrudes into medicine and impedes access to safe, evidence-based reproductive health services, including abortion and contraception.
Restricting access to life-saving pharmaceuticals like mifepristone, contraception, diabetes treatments, cancer medication, and to one’s personal health choices, do not make care safer; rather it endangers lives. Placing barriers for political and ideological purposes, with no evidence-based rationale and in direct opposition to people’s lived experiences, is not only dangerous; it is cruel and unjust.
Court rulings that ignore decades of scientific research and stringent policies the FDA has in place on all approved drugs – inclusive of ongoing monitoring of a drug’s safety beyond its approval – threatens the health and lives of people.
The urgency of safeguarding women’s healthcare could not be more apparent and necessary. To achieve this, courts must respect scientific evidence, not partisan politics that threaten to upend the health and lives of the people our legal system commits to serving.
Michele Goodwin is a Chancellor’s Professor at the University of California, Irvine and the author of “Policing the Womb: Invisible Women and the Criminalization of Motherhood.”
Dr. Eva Lathrop is an OBGYN and the Global Medical Director at Population Services International, a global health NGO.