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.

Since sending that letter, the FDA unexpectedly approved a generic form of the chemical abortion drug. RFK, Jr., and Dr. Makary have regulatory tools at their disposal that could begin the process of removing these dangerous drugs from the market. It is time for them to take decisive action.

The FDA first approved mifepristone in 2000 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.

How could the FDA so blatantly disregard its own rules? Because the approval of chemical  abortion 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. Over the next seven years, the Clinton administration worked to have the patent rights transferred to the Population Council, which then sought the FDA’s approval.  That transfer of patent rights was necessitated by the fact that the French company that owned the patent was unwilling to introduce the drug to the American market without indemnification of liability for the harms it would foreseeably cause.

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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.

These restrictions did not make mifepristone safe, but they did reduce the risk of harm to women. For example, in-person consultations provided women with necessary procedures, such as ultrasounds, critical for recognizing ectopic pregnancies, which, if left untreated, are deadly.

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

Armed with this and other data, the heads of HHS and the FDA have legal authority to call for a hearing to determine whether the FDA’s initial approval of mifepristone should be withdrawn. This would be an important step toward removing dangerous chemical abortion drugs from the market, and allow the agency to delay approval of any other generic forms of mifepristone currently being considered.

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. The FDA’s recently announced review is a good first step, but 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.