In exciting news this week, the American Civil Liberties Union (ACLU) filed a lawsuit against the FDA in an effort to remove medically unnecessary barriers and make medication abortion more accessible. Since its approval in France in 1987, scientists and doctors have known that medication abortion, also called abortion with pills, is a safe and effective way to end a pregnancy. But from its very first approval in the United States in 2000, medication abortion has been burdened with politically motivated, medically unnecessary restrictions.
Along with scientists and other women’s health activists, the NWHN has been at the forefront of making medication abortion accessible to everyone who needs it. Our only vested interest is in women’s health, and we have always been willing to oppose a drug or device we believed was unsafe, even when we agreed with its purpose. Because we can say without hesitation that medication abortion is an extremely safe and effective method to end an early pregnancy, we pushed for FDA approval in 2000 and we pushed for an updated label in 2016, which eliminated some of the excuses anti-choice politicians were using to restrict access on the state level.
So what is this lawsuit about and why is it so exciting? First, a little background. When pregnant people visit the doctor for an abortion using pills, they are most often prescribed two different drugs, to be taken 1-2 days apart. Mifepristone (brand name Mifeprex) is taken first. Misoprostol (brand name Cytotec) is taken second, between 24-48 hours after mifepristone is taken. Mifepristone used in combination with misoprostol is up to 99% effective, and serious complications are rare. In fact, as the Association of Reproductive Health Professionals has noted, mifepristone is safer than Tylenol, Aspirin, and Viagra.
Under the law, the FDA is only supposed to impose a Risk Evaluation and Mitigation Strategy (REMS) restrictions on the most dangerous drugs. Yet the FDA imposes a REMS on mifepristone without a scientific rationale, and regulates it as strictly as some of the most dangerous drugs on the market. Instead of simply filling a prescription at a pharmacy, a person seeking an abortion must be handed mifepristone by a clinician who has pre-registered with the drug manufacturer and keeps the abortion pill in stock and on site. That requirement isn’t based on science, but rather on ideological concessions to abortion opponents.
Even worse, women impacted the most by these measures are the most vulnerable. Low income women are disproportionately affected, while wealthy women have more resources to pay for doctor visits, or travel long distances to a clinic. The lack of accessibility to mifepristone is not just an issue of sex and gender discrimination, but also of racial and class-based discrimination. The ACLU case will challenge whether the FDA is violating the law by imposing REMS restrictions on mifepristone without a sound scientific reason.
Thankfully, recent cases show the incredible momentum surrounding women’s rights to access the care that they choose. In a 2016 case, Whole Woman's Health v. Hellerstedt, the Supreme Court ruled that the state of Texas could not impose an undue burden on women seeking abortion services. The ACLU case could dramatically expand women’s access to safe, effective reproductive health care. As the case moves forward, you can count on us to build public pressure for change and keep you informed.
Sarah Christopherson, MA, is the Legislative Director for the social justice campaign, Americans for Tax Fairness, and the NWHN’s former Policy Advocacy Director. Her 10 years working for Congress and her deep knowledge of health policy and consumer protection make her the NWHN’s issue area expert on federal health reform implementation and defense, drug and device safety and efficacy, and sexual and reproductive health.
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