The FDA’s Review Of Abortion Drugs Is Long Overdue

Last month marked 25 years since the Food and Drug Administration approved the abortion drug mifepristone, then called RU-486, for use in the United States.

On September 19, Health and Human Services Secretary Robert F. Kennedy, Jr., and the FDA Commissioner Marty Makary, sent a letter to 22 pro-life state attorneys general informing them that the agencies will perform a review of the drug’s safety.

Such a review is long overdue and should result in the revocation of the FDA’s approval of mifepristone or, at minimum, the restoration of important protections around the drug’s prescription.

The FDA’s approach to mifepristone was political from the start. In his first official act as President, Bill Clinton directed HHS to promote the introduction of the abortion drug into the American market. The first hurdle the FDA faced in carrying out this directive was the need for the French company Roussel Uclaf, which owned the patent to mifepristone, to file a new drug application (“NDA”) with the agency.

Before Roussel Uclaf would be willing to file the NDA, however, it wanted the federal government to indemnify it against damages it might incur as the drug’s sponsor. Because such indemnification was not politically feasible, “Roussel Uclaf was willing to give a royalty free license to any major U.S. pharmaceutical company — but no U.S. company would take the license.”

So, at the request of the Roussel Uclaf board, Clinton wrote a letter to the company urging it to grant a license to the Population Council, a nonprofit that had been in negotiations with the company with the support, if not at the direction, of the administration. License in hand, the Population Council filed an NDA in 1996, which the FDA quickly moved from standard to priority review.

In February 2000, the FDA sent a letter to the Population Council informing it that insufficient information had been presented to show the safety of the abortion drug. Nonetheless, that September, in the waning days of the Clinton administration, the FDA approved mifepristone.

The FDA approved mifepristone under a regulation known as Subpart H, which allows for the expedited approval of drugs that treat “serious or life-threatening illnesses and that provide a meaningful therapeutic benefit to patients over existing treatments. Mifepristone meets neither of these requirements.

First, mifepristone does not “treat” a “serious or life-threatening illness.” Pregnancy is not an illness, and killing an unborn child is not treatment.

Second, chemical abortion does not now, and certainly did not then, provide a “meaningful therapeutic benefit…over existing treatments.” As a 2006 congressional report on mifepristone’s approval explained, “it appears that no concurrently-controlled trials comparing medical and surgical abortion were required by FDA, because the Agency already knew that medical abortion — i.e., abortion by RU-486 — is unambiguously inferior to surgical abortion with respect to safety and effectiveness.”

Nor, as the same report lays out in detail, did the FDA rely on studies of sufficient rigor to meet Subpart H’s requirements.

Upon approval of mifepristone, the FDA implemented certain limitations on the drug’s prescription to provide at least some protection to women. Specifically, the abortion drug could only be prescribed to women who were less than seven weeks pregnant, women were required to visit the doctor three times, and abortionists were required to report all adverse events.

In March 2016, the Obama FDA significantly reduced these protections, now referred to as a Risk Evaluation and Mitigation Strategy (REMS). Women could be prescribed mifepristone for abortions up to 10 weeks of gestation, only needed to visit a doctor once, allowed non-doctors to prescribe chemical abortions, and required abortionists to report only fatal adverse events.

In 2021, the FDA “removed the ‘in-person dispensing requirement’” altogether.

In 2023, 63% of abortions were chemical rather than surgical, and tens of thousands of chemical abortions were shipped into pro-life states in 2024.

The FDA’s review of the dangers of mifepristone to women’s health is long overdue. A recent study by the Ethics and Public Policy Center, suggesting that the adverse event rate for chemical abortion is much higher than what the FDA data reports, is only the most recent in two and a half decades of evidence that the FDA’s approval of the drug is dangerous for women.

For the past 25 years, mifepristone has been used to terminate innocent human life while injuring and harming women for life. The abortion drug’s reckoning is long overdue. Pro-life Americans cannot rest until the dangerous chemical abortion pill is taken off the market and pre-born Americans are safe from its harms.

Marc Wheat is general counsel for Advancing American Freedom.