Shortly before the federal government shut down last week, officials at the Food and Drug Administration quietly approved a second generic form of mifepristone, the first of two drugs typically used in a medication abortion. In a letter dated September 30, the FDA told the manufacturer, Evita Solutions, that it had approved its 2021 application to market the generic. The development seemed like a rare piece of good news for supporters of abortion rights who are no doubt desperate for a win.
But the truth is that this development doesn’t mean anyone can rest easy about abortion-pill access going forward. To understand why, it’s important to know that medication abortions are a top target of the anti-abortion movement. A regimen of mifepristone and misoprostol is a safe and effective method of ending a pregnancy that is FDA-approved for use through ten weeks of pregnancy, though studies show it can be safely used later. Nearly two-thirds of all reported abortions in 2023 were done with pills — up from 31 percent in 2014 — and so-called “shield” laws passed after the Dobbs decision, which allow clinicians to prescribe pills across state lines, have contributed to a jump in abortions via telemedicine. By the end of 2024, one in every four abortions in the U.S. was done with pills prescribed via telehealth.
Conservative activists and lawmakers view mifepristone, and telehealth prescriptions of it, as a threat not only to enforcement of state bans but also to their larger project of banning abortion nationwide. Many of them reacted to the generic’s approval with outrage as they’ve been hounding the Trump administration to reimpose outdated restrictions on the drug, like requiring multiple in-person visits to a provider, and pressured the FDA to conduct an unnecessary safety review.
Here’s what you need to know about the current state of access to abortion pills, including the attacks that are coming down the pike.
While the drug won’t hit the market for a few more months — Evita Solutions told NBC News that it expects it to be available in January 2026 — its approval will expand the available supply of abortion pills. There’s already been a generic form of mifepristone on the market since 2019, made by a company called GenBioPro, so it’s not clear just how much having another manufacturer in the mix will change things in terms of patient access or affordability.
The Associated Press called the approval a “regulatory formality,” and multiple Trump administration spokespeople, including White House press secretary Karoline Leavitt, have stressed to reporters that the move is not an endorsement of the drug. A Health Department spokesperson said, “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.” Health secretary Robert F. Kennedy Jr. also emphasized on social media that the FDA was basically forced to approve the drug and that it changes nothing about the in-progress review. He then attached photos of a letter that he and FDA commissioner Marty Makary wrote to 22 Republican attorneys general on September 19, saying that they were reviewing evidence on mifepristone’s safety and efficacy.
The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined @DrMakaryFDA in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on… pic.twitter.com/G0eE4H4y42
— Secretary Kennedy (@SecKennedy) October 2, 2025
That effort will continue full steam ahead, and it could result in the FDA weaponizing junk science to end telemedicine prescriptions of mifepristone. Kennedy and Makary’s letter to the Republican AGs was a reply to a missive that the officials sent in July urging the pair to reinstate unnecessary restrictions. Specifically, they asked the FDA to reverse updates that it made in 2016 and 2023, which expanded use from seven weeks of pregnancy to ten, permitted advanced-practice providers like nurse practitioners to prescribe the drug, and permanently allowed for telemedicine prescriptions that began at the height of the pandemic.
The AGs cited a bogus data analysis from the far-right Ethics and Public Policy Center (EPPC), a Project 2025 advisory board member, which overstates complications of mifepristone. The paper was not peer-reviewed, and yet conservatives are trying to pass it off as a legitimate study. Alarmingly, Kennedy and Makary said the EPPC paper indicated “potential dangers” from prescribing mifepristone “without sufficient medical support or supervision.” Any changes the FDA may try to make to abortion pills as a result of their study will likely be met with lawsuits around whether the agency followed proper protocols, which brings us to some existing litigation.
An active lawsuit could also result in abortion-pill restrictions. The same day the FDA approved the new generic, a Trump-appointed federal judge in Texas chose to keep alive a case that even the conservative-majority Supreme Court said he should dismiss. In November 2022, a group of anti-abortion doctors sued the FDA for loosening restrictions on mifepristone; in 2024, the high court said the physicians weren’t the right plaintiffs to sue and that the case should be thrown out. But as this shoddy case was advancing through the courts, the AGs of Missouri, Kansas, and Idaho asked to join the suit in Texas; even Trump’s Justice Department didn’t buy this argument. In May, the DOJ said those states have no connection to Texas and that the case had to be either dismissed or transferred. Last week, Judge Matthew Kacsmaryk transferred the case from his courtroom to the Eastern District of Missouri. These Republican AGs will now continue to make their claim that the FDA acted improperly when it loosened restrictions on mifepristone in 2016 and 2023 and that the agency’s actions interfere with their ability to regulate abortions.
Yes. These cases target the shield laws mentioned earlier, which help people living in states with bans access medication abortion via telemedicine. In general, the laws protect clinicians from being sued or criminally charged by other states for practicing medicine that’s legal in their state.
In December, Texas attorney general Ken Paxton sued a New York physician named Maggie Carpenter for allegedly prescribing medication-abortion drugs to a Texas woman. As directed under the shield law, Carpenter didn’t respond to the suit, and Paxton won a $113,000 judgment against her in Texas court. He tried to collect the penalty, but a New York county clerk refused to accept his filing multiple times. Paxton turned around and sued the clerk in state court this summer and, last month, New York attorney general Letitia James said she was joining the case to defend the constitutionality of the shield law. Paxton argues that the law violates the Constitution’s Full Faith and Credit Clause, which says that states generally must respect each other’s laws. This is swiftly becoming an interstate conflict that is headed to the Supreme Court for a resolution.
There are also federal cases in the works: Anti-abortion lawyer Jonathan Mitchell, best known for being the brains behind Texas’s bounty-hunter law, is helping a Texas man sue a California physician for allegedly prescribing pills to his girlfriend. Mitchell is also representing a Texas woman who is trying to sue Aid Access, a telemedicine service run by Dutch physician Rebecca Gomperts, alongside her own boyfriend, who she claims ordered abortion pills and tricked her into taking them. (The boyfriend accused the woman of lying in a countersuit.) These cases, which were filed in July and August, respectively, aren’t as far along as the New York dispute.
Given the makeup of the federal courts and the 6-3 conservative supermajority on the Supreme Court, it’s difficult to imagine that judges will swat away every single attack on mifepristone. If access to the drug becomes restricted, however, providers can prescribe misoprostol-only abortions, which are commonly performed in other countries. Research has shown it is safe but slightly less effective than the two-pill regimen. Many U.S. abortion providers have been prepared to offer this option since the first mifepristone lawsuit was filed in 2022.
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