Today’s primary abortion battleground is the prescription pad.
Now that most abortions are chemical rather than surgical, pro-life advocates have amped up pressure on lawmakers and officials to restrict access to abortion pills—but the US Food and Drug Administration (FDA) this week approved another generic version of the drug mifepristone.
The move is a reversal from just over a week before, when Health and Human Services Secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary confirmed plans to reexamine the safety of mifepristone.
Conservatives had been asking for the review for months, prompted in part by a study from the Ethics and Public Policy Center (EPPC).
“The FDA just said it would do a new serious safety study—so why approve another generic now?” asked Lila Rose, president of Live Action.
Kennedy claimed the FDA gave the drug a green light only because federal law requires the agency approve generics that are identical to brand-name drugs already on the market.
The FDA first authorized a generic version of mifepristone from GenBioPro in 2019. The company says it accounts for two-thirds of mifepristone in the US. Drugmaker Evita Solutions expects its newly approved generic to be available starting January 2026.
“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement. “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.”
Dannenfelser fundamentally opposes abortion for ending life in the womb but also noted that the drugs can result in hemorrhaging, infection, and sepsis in patients.
Doctors prescribe mifepristone, along with a dose of misoprostol, to induce abortions up to 10 weeks of pregnancy. The drugs can be dangerous to women in pregnancies further along as well as in ectopic pregnancies, when the embryo grows outside the uterus.
The EPPC study reported higher levels of complications resulting from medication abortions—1 in 10 by its count—as more women take the pills without adequate medical oversight. Last year, a quarter of abortions occurred without patients seeing a doctor in person, instead getting medication prescribed through telehealth visits.
Kennedy said women taking mifepristone have fewer safeguards since the Biden administration dropped requirements for providers to dispense the drugs in person, often after a sonogram. In a September 19 letter, Kennedy and Makary told a group of Republican state attorneys general that their concerns over mifepristone “merit close examination” and that HHS is “committed to studying the adverse consequences.”
Pro-life leaders see the recent drug approval as undercutting that commitment. Dannenfelser criticized the Trump administration’s handling of the issue and told The Washington Post that it should be an “easy lift” for officials to restore the previous safety regulations. “‘Powerless’ is an adjective no one uses to describe this administration when facing trouble,” Dannenfelser said.
Students for Life president Kristan Hawkins said the approval was “a stain on the Trump Presidency and another sign that the deep state at the FDA must go.” She blamed officials for “putting industry interests over patient safety.”
Missouri senator Josh Hawley said he’s “lost confidence in the leadership at FDA.”
Former vice president Mike Pence called the decision “a complete betrayal of the pro-life movement that elected President Trump” and said Kennedy, once an independent who favored legal abortion, was unfit to lead HHS.
During his confirmation hearing in March, Makary faced questions over whether he would continue to permit access to mifepristone by telehealth.
The Biden administration made permanent what was at first a pandemic provision. Senators accused Makary of hedging on the issue when the former Johns Hopkins surgeon said, “I have no preconceived plans on mifepristone policy except to take a solid, hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA.”
When the FDA first approved mifepristone and misoprostol for abortion in 2000, they made up just 5 percent of abortions in clinical settings. That figure is now 63 percent. Abortion by mail has taken off among women in states where there are few abortion businesses or where post–Dobbs abortion bans are in effect.
Pro-life advocates have raised safety concerns around the potential for partners to obtain abortion pills and give them to pregnant women without consent. In the UK, a “Pills by Post” program that also took off during the pandemic faces similar scrutiny. There, a man who spiked a woman’s drink with drugs from the program received a sentence of 17 years in prison.
In December, a new Texas law will make it possible for anyone to sue a doctor who prescribes abortion pills, a company that mails them, or an individual who orders them for others. Successful plaintiffs who are related to the unborn child can receive at least $100,000 from the defendant. Others can receive $10,000 and must donate the rest of the penalty amount to a charity or nonprofit.
