The FDA Should Pause and Reassess Its Generic Abortion Pill Approval

Earlier this month, the Food and Drug administration approved a generic version of mifepristone, a generic abortion pill, despite serious questions about the drug’s safety and its impact on both women and unborn life.

Fortunately, 51 U.S. Senators sent a letter to the FDA urging the agency to pause this new approval until the promised safety review is complete. Because of the government shutdown, millions of pro-life Americans – who recently made their voices heard in the previous election – are left waiting to hear whether the FDA will pause its greenlighting of this generic abortion pill.

As the CEO of the Faith and Freedom Coalition, the country’s largest faith-based grassroots organization, protecting life is indispensable to our work and mission.

Our coalition, consisting of millions of parents, pastors, small-business owners, and faith leaders, expects government institutions to honor both science and the sanctity of every human life. Beyond protecting the sanctity of life, Americans must be able to trust that decisions affecting life and health are made only after rigorous, unbiased review and not rushed.

This is why we joined the Senators in urging the FDA and HHS to complete their comprehensive safety review before allowing new generic versions of mifepristone to enter the market. Doing so would reaffirm the agencies’ commitment to women’s health, to the integrity of science, and to the principle that no life is expendable.

The good news is that in recent weeks, federal officials have acknowledged significant data discrepancies in how abortion pill complications are reported and tracked. We welcome their commitment to reexamining the science and conducting a comprehensive review of the Risk Evaluation and Mitigation Strategies (REMS) that govern the drug’s use.

This type of oversight — rooted in transparency, accountability, and compassion — is essential to ensuring that public health decisions truly protect women and uphold the rule of law.

That is why the timing of the FDA’s latest action is troubling. Approving a new generic version of mifepristone in the middle of an ongoing safety reassessment sends mixed signals about the agency’s priorities. It risks undercutting confidence in the very review process the administration has rightly committed to strengthening. A pause — not a reversal, but a prudent pause — would demonstrate respect for both science and safety.

There are also legitimate concerns about how the distribution of abortion pills intersects with state laws enacted after the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization. States have the constitutional authority to protect unborn life and regulate abortion within their borders. Yet unrestricted mail-order access to these drugs risks undermining those state protections and creating confusion for women, doctors, and pharmacies alike. Federal agencies must take care not to override the will of the people expressed through their elected legislatures.

Beyond the legal and procedural issues lies a shared responsibility to value every human life — mother and child alike. Compassion and caution should not be in conflict. Women deserve the highest standards of medical care and the fullest possible information about the risks involved. The unborn deserve the same basic protection our laws promise to every member of the human family.

Protecting life — both born and unborn — should unite us. In moments of controversy, government agencies have the chance to rebuild public trust through humility, transparency, and respect for the democratic process. A pause now would be an act not of politics, but of prudence.

Mary Thomas is the CEO of the Faith and Freedom Coalition.