In early September, Health and Human Services Secretary Robert F. Kennedy Jr. informed the Senate that the Food and Drug Administration (FDA) would review the safety of the abortion drug mifepristone.
A few weeks later, however, some members of the Senate and House, along with pro-life advocates, were appalled to learn that the FDA had just approved a generic form of the drug.
The generic version, made by Evita Solutions, is considered the same as the brand-name drug Mifeprex in safety and effectiveness, according to various reports. Before it can be sold, the company must follow the FDA’s safety rules and compliance requirements under the Mifepristone REMS Program, which controls how the drug is prescribed and distributed.
Members of Congress and the pro-life community immediately condemned the FDA’s approval of the generic abortion drug, calling it reckless, dangerous for women, and disrespectful to the value of human life. They argued that the approval expanded access to abortion and ignored serious safety concerns tied to chemical abortions.
In a letter to Secretary Kennedy and Commissioner Dr. Marty Makary, 50 Republican Senators urged further review of abortion drugs and criticized the FDA’s approval of a new generic mifepristone, claiming abortion pills endanger women, violate state laws, and are easily accessed by minors and abusers. The letter cited studies suggesting high complication rates and accused the Biden-Harris administration of weakening safeguards.
“We are deeply concerned about the FDA’s approval of a new generic version of mifepristone,” the senators wrote. “While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized. Out of respect for this important review, and with full confidence in your dedication to protecting women’s health, states’ rights, and unborn life, we urge you to take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”
In the House of Representatives, Values Action Team Chairman Robert Aderholt and members released a statement expressing an urgent call for action.
“The FDA’s approval of a new generic version of the abortion pill, mifepristone, endangers women’s health and disregards the value of life. Previously approved versions of this drug demonstrated dangerous side effects including life-threatening sepsis, infection, and hemorrhaging,” the statement said. “The FDA’s own fact sheet on mifepristone shows troubling rates of adverse events including hospitalization, blood transfusions, and even death following use of this dangerous drug. Even more troubling, a recent large-scale study shows significant underreporting of these adverse events.”
“I urge HHS to quickly expedite its thorough investigation into the harmful effects and adverse events associated with mifepristone, as already promised by Secretary Kennedy. We must protect women from the dangers and serious risks of chemical abortion,” Aderholt said.
Pro-life leaders were equally as adamant in expressing disappointment and extreme concern.
In an op-ed for USA Today, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, wrote that it was ironic how the approval came barely a week after the Trump administration warned pregnant women to reconsider taking Tylenol to avoid harm to their unborn children.
“The FDA must reverse course,” she said. “Cooperating with pharmaceutical companies to bring new life-ending drugs to market doesn’t make America greater or healthier.”
In a Baptist Press article, Southern Baptist Ethics and Religious Liberty Commission Interim President Gary Hollingsworth said the FDA’s decision should weigh heavily on the hearts of denominational members, “who boldly and bravely speak the truth of God as the creator and giver of life.”
“We affirm that life is a sacred gift, not a commodity to be regulated or discarded,” Hollingsworth added. “In response, the ERLC is sending a letter to [Health and Human Services] and the FDA, urging them to take action with the ultimate goal of removing this dangerous, life-taking drug from the market for good.”
In July, 40 Southern Baptist leaders from 22 states urged President Trump to end mail-order abortion pill sales, citing women’s safety and violations of the Comstock Act. The group asked him to restore FDA safeguards, enforce the law, and protect pro-life state policies undermined by Biden-era regulations on mifepristone.
A recent article in WORLD Magazine noted that chemical abortions account for about two-thirds of all abortions in the country; the rate increased in 2023 after the Biden administration allowed retail pharmacies to dispense mifepristone and misoprostol directly to women without an in-person medical visit.
The article also explained that the FDA has only limited discretion in deciding whether to approve a generic drug if the manufacturer proves it is identical to the brand-name version (according to Health and Human Services spokesman Andrew Nixon).
In a column for WORLD Magazine entitled “Putting Women at Risk,” Erin Hawley wrote that the FDA has abdicated its responsibility with the approval of the generic abortion drug.
“The approval is not about empowering women. It is about expanding abortion at any cost,” said Hawley, senior counsel at Alliance Defending Freedom.
“Make no mistake, mifepristone is not your ordinary drug. Most obviously, it intentionally takes the life of an unborn child. Drugs approved by the FDA are supposed to provide a ‘therapeutic benefit.’ Yet pregnancy is not a disease—and rather than curing an illness, mifepristone takes a human life.”