On October 2, 2025, the U.S. Food and Drug Administration (FDA) quietly approved a new generic version of mifepristone, the medication at the heart of most medication abortions in the country. The move, which expands the supply of this pivotal drug, has ignited a fierce debate—one that reflects the broader national struggle over abortion access since the Supreme Court overturned Roe v. Wade in 2022.
The newly approved generic, produced by Evita Solutions, is now the second such version available in the United States, following GenBioPro’s earlier entry in 2019. According to a letter from the FDA to Evita Solutions, the agency determined that the company’s 200 mg mifepristone tablets are "bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mifeprex (mifepristone) tablets, 200 mg, of Danco Laboratories." As a result, three American companies are now authorized to manufacture mifepristone for abortion care.
Mifepristone, when used in combination with misoprostol, is the cornerstone of medication abortions—an option chosen in nearly two-thirds of all U.S. abortions, according to The Hill and Reuters. The drug was first approved by the FDA in 2000 and is used to terminate pregnancies up to 10 weeks. It works by blocking progesterone, a hormone that supports pregnancy, while misoprostol induces contractions to complete the process. The increased availability of mifepristone, especially via telemedicine, has helped keep abortion numbers steady, even as states have enacted new restrictions post-Roe.
Evita Solutions, the company behind the new generic, describes its mission as helping "the medical community in recognizing the utility and freedom that medical abortion provides patients." On its website, the company states: "We seek to normalize abortion care, and we commit to making care accessible to all." The product, according to the company, will be “coming soon.”
The FDA’s approval did not come with the usual fanfare; there was no press release, and the announcement was made the day before a government shutdown began. But the decision has set off a firestorm of reactions from both sides of the abortion debate.
Supporters of abortion rights celebrated the approval as a victory for science and patient access. Mini Timmaraju, President and CEO of Reproductive Freedom for All, which has advocated for reproductive rights for over 55 years, said in a statement: “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—evaluating the evidence and approving a safe, effective medication. The only reason this routine approval is making headlines is because anti-abortion politicians have turned health care into a political battlefield. We miss the days when this didn’t require a comment.”
Brittany Fonteno, CEO of the National Abortion Federation, echoed this sentiment, stating, “The approval of a second generic drug for mifepristone underscores what research has shown for decades: medication abortion is safe, effective, and essential health care, used by millions with proven efficacy.” Peer-reviewed studies, as cited by Reuters and The Hill, have consistently found that serious adverse events from mifepristone are exceedingly rare.
But the approval has been met with outrage from anti-abortion activists and some conservative lawmakers. Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, called the FDA’s decision “unconscionable.” In a statement to The Hill, she said, “These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation.” Senator Josh Hawley (R-Mo.) took to social media to voice his concerns, writing, “This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child.”
The political landscape surrounding mifepristone has been fraught, with the Trump administration previously targeting the medication and conservative groups consistently pushing for tighter restrictions. Just last month, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced that the agency would review the safety of mifepristone, citing "recent studies raising concerns about the safety of mifepristone as currently administered." In a letter to Republican state attorneys general, Kennedy and Makary acknowledged that previous decisions to ease restrictions on the drug—such as allowing it to be prescribed via telehealth and mailed nationwide—had not been given “adequate consideration.”
Andrew Nixon, a spokesperson for the Department of Health and Human Services, clarified the FDA’s legal obligations in a statement to The New York Times: “The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug.” Nixon added, “Generic applicants are not required to submit independent evidence proving safety and effectiveness.”
Despite the uproar, the FDA has maintained that mifepristone is "extremely safe," and that its decades-long track record supports this conclusion. The agency is currently conducting a review of reported adverse effects, but emphasizes that "serious adverse events are exceedingly rare," a point echoed in peer-reviewed research.
Meanwhile, the approval comes at a time when access to abortion pills has become a flashpoint in the broader battle over reproductive rights. Since the Supreme Court’s 2022 decision, many states have moved to restrict abortion, but the availability of medication abortion—especially through telemedicine—has helped many patients continue to access care. According to The New York Times, this has played a key role in maintaining abortion numbers nationwide, even as clinics have closed and legal hurdles have increased.
Anti-abortion groups, however, remain determined to challenge the FDA’s approval process and push for more restrictive policies. They have cited reports—such as one from the Ethics and Public Policy Center, which claimed a higher rate of complications from mifepristone than the FDA has reported—as justification for further scrutiny, even though reproductive health researchers have dismissed these findings as “junk science.”
The debate over mifepristone is unlikely to fade anytime soon. With three companies now able to manufacture the drug, and the FDA’s review process under the microscope, both sides are gearing up for further legal and political battles. As the controversy continues, millions of Americans—patients, providers, and advocates alike—will be watching closely to see how the next chapter unfolds.
For now, the FDA’s decision stands as a testament to the enduring complexities of American health policy, where science, law, and ideology are often on a collision course.
