The resignation of FDA Commissioner Dr. Marty Makary creates an opportunity for the agency to return to its mission of protecting the public by ensuring drugs are safe. Whether Kyle Diamantas is running the agency long-term or the administration expediently appoints someone new, now is the time to address the most significant public health crisis of our time: the widespread distribution of mail-order abortion drugs.
During the COVID-19 pandemic, the Biden administration recklessly stripped away basic requirements for the abortion drug mifepristone, such as in-person doctor’s visits. The intention was to expand abortion nationwide if Roe v. Wade was overturned. This mail-order policy has pushed abortion drugs into pro-life states, violating their laws, ending lives, and endangering women and girls. And it’s still in place.
This Biden policy is the reason abortions have risen, not fallen, in the post-Dobbs era, with more than one million unborn children dying annually. Even in states with strong pro-life protections, tens of thousands of abortions persist each year, driven in large part by this unchecked spread of mail-order abortion drugs. We know 90,000 abortions are occurring annually just in the states that protect life all throughout pregnancy.
Mifepristone is manufactured and distributed to kill unborn children, but it is also highly dangerous for women. In September, HHS Secretary Robert F. Kennedy, Jr. confirmed that the Biden administration “twisted” data on abortion drug safety and there would be a necessary review. Studies indicate that even when these drugs are given in person with oversight, as many as 11% of women who take these drugs experience serious adverse effects, including hemorrhaging, infection, and sepsis. Peer-reviewed research further shows that roughly three-quarters of emergency room visits following abortion drug use are classified as severe or critical. According to the FDA’s own label, abortion drugs send approximately one in 25 women to the ER.
This policy shift has also created fertile ground for abuse. Without in-person screening, there is little to prevent coercion or forced abortions. Cases like that of Rosalie Markezich – whose boyfriend allegedly ordered abortion drugs online from California and pressured her to take them against her will – highlight a disturbing reality. When you peddle drugs online to anyone, vulnerable women and their children are left exposed to manipulation, violence, and irreversible harm.
Thankfully, Republican attorneys general have challenged the Biden policy, with one case brought by Louisiana rising to the top. The 5th U.S. Circuit Court of Appeals recently moved to halt the FDA’s mail-order abortion drug policy, signaling that challenges to this regulatory framework have substantial merit. The court called the Biden policy “federal interference” that nullifies Louisiana’s pro-life law and said the policy “lacked a basis in data and scientific literature.” The court said, “FDA’s own documents prove that emergency room care is statistically certain in hundreds of thousands of cases.”
Looking ahead, the path forward is clear. It is time for the FDA to return to the standard of in-person doctor visits that was in place during the first Trump administration and to fully study mifepristone. While it is my hope that mifepristone will be completely taken off the market someday, going back to basic safety standards will allow pro-life laws to take effect and add a critical layer of protection for women. Face-to-face evaluations allow for screening of ectopic pregnancies, to assess gestational age, to identify risk factors, and to detect signs of coercion.
Public opinion strongly supports this approach. Polling consistently shows that 71% of Americans – including majorities of Independents, Democrats, and even self-identified liberals – favor reinstating in-person medical oversight for abortion drugs.
Now is the time for the FDA to do the right – and the politically smart – thing. Return to the Trump administration policy of in-person doctor visits to save lives.
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Marjorie Dannenfelser serves as president of Susan B. Anthony Pro-Life America. She has been called “the woman who brought down Roe.”
