On October 3, 2025, the U.S. Food and Drug Administration (FDA) quietly approved a new generic version of the abortion pill mifepristone, manufactured by Evita Solutions LLC. The move, which on the surface is a straightforward regulatory formality, has ignited a fierce and immediate backlash from anti-abortion advocates and conservative politicians, while drawing praise from abortion-rights supporters and medical professionals. This latest development is only the newest chapter in the decades-long battle over medication abortion access in the United States.
Evita Solutions, a company whose stated mission is to "normalize abortion" and make it "accessible to all," announced on its website that the FDA had signed off on its low-cost form of mifepristone, approved for use to end pregnancies through 10 weeks. The company expects to launch the drug in January 2026, four years after first filing its application with the FDA. According to the company's statement, it "believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care."
The FDA originally approved mifepristone in 2000 during the Clinton administration. Since then, the agency has gradually eased access, including approving the first generic version from GenBioPro in 2019 and, in 2021 under President Biden, permitting online prescribing and mail-order delivery. These measures have significantly expanded access to medication abortion, which now accounts for about two-thirds of all U.S. abortions. Mifepristone is typically taken with another drug, misoprostol, in a two-step regimen: mifepristone blocks the hormone progesterone, ending the pregnancy, while misoprostol induces contractions to expel the remains.
Yet, the FDA’s latest approval has been anything but routine. Students for Life Action, a prominent anti-abortion group, condemned the move as "a stain on the Trump presidency and another sign that the deep state at the FDA must go." Republican Senator Josh Hawley of Missouri echoed the sentiment, posting on X, "I have lost confidence in the leadership at FDA." These criticisms underscore the political pressure facing top federal health officials, including Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, both of whom have pledged to conduct a full review of mifepristone’s safety in a letter to Republican state attorneys general last month.
In response to the uproar, an FDA spokesperson emphasized the agency’s limited discretion in generic drug approvals, explaining, "The FDA has very limited discretion in deciding whether to approve a generic drug," and adding that FDA officials do not "endorse any product." Approval of generic drugs is typically a rote process, requiring only that the new version matches the ingredients and formula of the original medication. As Mini Timmaraju of Reproductive Freedom for All put it, "This is exactly how our system is supposed to work, and it has worked this way for decades. Career scientists and civil servants at the FDA did their jobs."
Despite these procedural explanations, the FDA’s decision has become a flashpoint for a coalition of pro-life advocates. On October 3, Kelsey Reinhardt, president and CEO of CatholicVote, led a group of prominent anti-abortion leaders—including Lila Rose, Kristan Hawkins, Ryan T. Anderson, Penny Nance, Jor-El Godsey, Tony Perkins, Most Rev. Michael F. Burbidge (Bishop of Arlington), Princeton Professor Robert P. George, and North Dakota state senator Janne Myrdal—in sending a sharply worded letter to Secretary Kennedy and Commissioner Makary. The letter called the FDA’s approval "reckless" and demanded that mifepristone be withdrawn from the market entirely.
“This decision should be immediately reversed, and mifepristone should be pulled from the market altogether,” the coalition wrote. “Rather than pausing to examine the mounting evidence showing the harmful effects of mifepristone, the FDA has chosen to expand access to a drug that has already killed millions of preborn children and harmed countless women.”
The coalition cited a new study by the Ethics and Public Policy Center, which analyzed 865,727 chemical abortions from 2017 to 2023 and found serious complications—such as hemorrhage, infection, and sepsis—in more than one in ten cases. According to the letter, this rate is "twenty-two times higher" than what the FDA’s "outdated data" suggests. In light of these findings, attorneys general from 22 states have urged the FDA to restore the stronger safety restrictions that existed before 2016 and to reconsider mifepristone’s approval altogether.
Further criticism was leveled at the FDA’s reliance on "only ten clinical trials involving fewer than 31,000 women, some of which date back more than forty years," for the drug’s labeling. The coalition also blasted the Biden administration’s telehealth and mail-order abortion policies, arguing that the removal of in-person medical oversight has put women at greater risk. They referenced recent criminal cases involving illicit distribution of abortion pills, including a Texas case where a woman was allegedly drugged by her partner using pills obtained online, as evidence for the need for "stronger safeguards and enforcement to protect innocent lives."
“Mifepristone is not medicine. It is a lethal drug designed to end the lives of preborn children, and in doing so, it places women at serious risk,” the letter continued. “The FDA’s mission is to protect public health. The American people expect decisive action, not delay, when lives are at stake.” The letter concluded with a direct appeal to Secretary Kennedy to honor his commitment before the Senate Finance Committee on September 4, 2025, when he vowed that his department would no longer "bury" safety data related to abortion drugs. “Every abortion is a violation of human rights, and every life lost is an irreplaceable son or daughter. The federal government must stop enabling this violence under the false banner of ‘healthcare.’”
On the other side of the debate, abortion-rights advocates and major medical organizations, including the American Medical Association, have consistently argued that restrictions on mifepristone are not supported by scientific evidence. They point out that the FDA and other regulatory bodies worldwide have repeatedly found the drug to be safe and effective. Approval of generic drugs, they insist, is a standard process, and expanding access helps ensure that patients can receive care in a timely and affordable manner.
Meanwhile, access to mifepristone remains sharply restricted across large portions of the United States due to state laws banning or limiting abortion, including medication abortion. These laws are the subject of ongoing lawsuits, creating a patchwork of access that varies dramatically from state to state. In Canada, by contrast, the combination of mifepristone and misoprostol—marketed as mifegymiso—is prescribed by doctors and nurse practitioners, with midwives also permitted to prescribe it in Québec.
As the legal and political battles rage on, the FDA’s approval of Evita Solutions’ generic mifepristone is unlikely to immediately affect access to the pill in states where it is already restricted. But for supporters and opponents alike, the episode is a stark reminder that the struggle over abortion rights in America is far from settled. The next round, it seems, is already underway.
