Today, a Texas judge’s decision declared unlawful the U.S. Food and Drug Administration’s (FDA) approval of mifepristone, an essential medication used in medication abortions. Mifepristone, when used in combination with misoprostol to assist abortion, has been recognized by the World Health Organization as a core medication on the Model Essential Medicines List where legal and culturally acceptable. The decision directly contradicts a simultaneous order from a Washington state judge, which prohibits the FDA from changing the availability of mifepristone. The Texas decision grants the federal government seven days to seek emergency relief before it goes into effect, which means that mifepristone remains available currently and this ruling may be challenged.
Under international human rights law, health systems are obligated to provide access to essential medicines, including mifepristone. Shifting mifepristone from legal to illegal is a significant regression in the implementation of the United States’ human rights obligations. Banning the medications required for abortion is a key strategy used by political leaders internationally who are seeking to limit reproductive autonomy. While this decision does not place any restrictions on misoprostol–which can be used on its own to safely terminate a pregnancy–medical professionals with Physicians for Human Rights (PHR) highlight that banning mifepristone contributes to the growing inaccessibility of abortion care by further limiting available means for safe services.
In response, the following statement is attributable to Michele Heisler, MD, MPA, medical director at PHR and professor of internal medicine and public health at the University of Michigan:
“As a physician, I find it unconscionable that a judge can overturn the FDA’s approval of a medication that has undergone rigorous clinical evaluation, meets all universal standards of effectiveness and safety, and has been regularly used safely for two decades. In a country that has already stripped protected rights from individuals in need of access to reproductive health care, this decision further compounds the risks and harms from the politicization of science and medicine. The criminalization of abortion potentially harms all pregnant people and disproportionately harms America’s most marginalized communities.
“This case and the broader campaign to restrict access to abortion care nationwide are not based in medicine or science. The ruling’s implications go far beyond restricting access to abortion. It is critically important for safeguarding the public’s health that the rigorous and independent processes by which the FDA investigates and approves medications not become subject to political influence. This decision now opens the door for non-scientists and non-physicians to block any FDA-approved medication that patients depend on.
“While this decision will not restrict pregnant people’s access to other abortion procedures in states where the right to abortion is still protected, eliminating access to mifepristone will place a heavier burden on already strained health system ravaged by three years of the COVID-19 pandemic and the Dobbs decision. This decision may lead to potentially dangerous delays in care for some patients, prevention of the best possible care for other patients, and a potential increase in the already unacceptably high maternal mortality and morbidity rate in the United States. These harms will undoubtedly be most severely experienced by marginalized communities, including Black, Indigenous, and low income people, communities that already face disproportionately high rates of maternal death and injury.
“The ruling represents an egregious rollback in human rights and public health. Even before this decision, The United States was joined only by El Salvador, Nicaragua, and Poland in removing legal grounds for abortion since 1994, placing the United States in breach of numerous international human rights obligations. It is critical that the government, including the FDA, take all steps to ensure that access to mifepristone is not hindered by this ruling.”
Physicians for Human Rights (PHR) is a New York-based advocacy organization that uses science and medicine to prevent mass atrocities and severe human rights violations. Learn more here.