FDA Confirms Abortion Pill Review

The abortion drug mifepristone will finally receive much-requested scrutiny by the Trump administration, Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary promised Republican attorneys general. After decades of pro-abortion administrations gradually loosening every last safeguard, the Trump administration’s FDA will conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug,” the Sept. 19 letter stated.

The letter comes in response to 22 state attorneys general who asked the FDA to review the drug. These officials cited concerns over new studies showing much higher rates of adverse events than the studies which were used to justify the drug’s initial approval. For instance, a major study published by the Ethics and Public Policy Center (EPPC) earlier this year showed that nearly 11% of women who take mifepristone experience serious adverse effects, including sepsis, infection, and hemorrhaging.

Notably, Kennedy and Makary’s letter struck a sympathetic tone to the state officials’ misgivings. “The concerns you have raised in your letter merit close examination. This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” they wrote.

The Trump administration has largely tried “to get out of the culture war side of the abortion issue,” as Vice President JD Vance put it, arguing that “abortion policy should be made by the states” after the Dobbs decision.

However, the Trump administration has so far left in place the federal abortion policy created by the FDA, approving the abortion drug mifepristone without any safety guardrails, such as an ultrasound to screen for gestational age or ectopic pregnancy. The Trump administration has also declined thus far to alter the federal abortion policy, pursued by the Biden administration, of not enforcing an abortion policy passed by Congress, which prohibits any product used for an abortion from being shipped through the mail.

These federal abortion policies create a loophole through which abortionists evade state laws that protect unborn life. These abortionists are located in pro-abortion states like New York, but they willingly ship abortion pills to women in other states, usually after a single telehealth consultation. According to an August study published in the Journal of the American Medical Association (JAMA), 84% of the chemical abortion pills shipped by one of the largest suppliers go into pro-life states.

Consequently, the Trump administration has not yet extricated itself from the abortion “culture war” as much as it had hoped. In effect, its policy of nonaction meant perpetuating Biden-era abortion policies that have used mifepristone to undermine state efforts aimed at protecting unborn life. The Trump administration cannot implement a truly “abortion-neutral” federal policy until it unwinds Biden-era (and Obama-era) actions to remove safeguards from the abortion pill.

Naturally, pro-life advocates were keen to see the Trump administration reverse its activist predecessor’s federal interference with pro-life state laws. Pro-life leaders have consistently lobbied on this point; as recently as late July, dozens of Baptist leaders urged “immediate action to stop the mail-order distribution of the abortion drug mifepristone, which now accounts for more than 60% of all U.S. abortions” and “has caused serious adverse events in nearly 11% of users and poses grave risks to women—especially when dispensed without in-person screening or ultrasound evaluation.” The recent letter by 22 state attorneys general continues the trend as evidence of the widespread momentum for restoring common sense safety precautions on mifepristone.

At first, Commissioner Makary would give no firm commitment to revisit mifepristone. On April 24, he said the FDA had no plans to limit access to mifepristone, although “if the data suggests something or tells us there’s a real signal, we can’t promise we’re not going to act on that data.”

Shortly afterward, the EPPC study revealed a shocking number of adverse events across an enormous body of data, and Secretary Kennedy admitted it warranted review.

Members of Congress kept up the pressure on Makary to initiate a review. In a letter responding to Sen. Josh Hawley (R-Mo.), Makary wrote on June 2 that he was “committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.” This was a start, although it gave no firm timeline, nor did it suggest what the outcome of that review might be.

The administration’s latest response to the coalition of attorneys general provides the firmest commitment to date from the Trump administration that it will follow through on a robust review. “Through the FDA, HHS will conduct a study of the safety of the current [safety protocol], in order to determine whether modifications are necessary,” Kennedy and Makary wrote. They added, “This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed.”

Unsurprisingly, abortion activists like the National Abortion Federation (NAF) immediately attacked this commitment, falsely dismissing the EPPC study as “junk science” and questioning the legitimacy of the FDA’s review (the NAF put “review” in scare quotes).

Also unsurprisingly, many mainstream media mouthpieces have taken their cues from this baseless attack. In an Axios article on the FDA’s proposed study of mifepristone, both the title and the first sentence place the word “study” in scare quotes, disparaging the review before it even begins.

Ironically, such news reports accidentally make the case for the review’s necessity by juxtaposing safety and access. “Federal agencies are studying safety of abortion drug mifepristone, driving new concerns about limits on access,” warns CNN’s title. If mifepristone is not safe, then it should not have access to the market. That’s the whole point of the FDA’s pharmaceutical review process.

Pro-life advocates are confident that an abundance of data demonstrates the dangers of the abortion drug, especially if prescribers are allowed to dispense it without restriction and ship it through the mail across state lines. All they want from the FDA is to give that data an honest review.

Originally published by the Washington Stand.

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