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The FDA fails to protect unborn life—and mothers

The agency’s new rule on abortion drugs endangers women


A CVS pharmacy in New York City iStock

The FDA fails to protect unborn life—and mothers

In a recent change, the FDA authorized chemical abortion drugs to be dispensed at corner pharmacies like CVS and Walgreens rather than by an abortion provider. The FDA’s action reiterates its decision to remove one of the last checks on the dispensing of a dangerous and medically unnecessary drug. It is an affront to the FDA’s purported mission—protecting public health. The FDA’s new regime makes it easier to access inherently dangerous drugs with serious and even life-threatening complications, harming countless women who will never see a physician before taking them.

The New York Times reports that the new pharmacy-dispensing rule was the result of an agreement between the FDA and the companies that make the chemical abortion drugs. And make no mistake. The prescription of death is profitable. These drugs can cost as much as $800 and over half of all the abortions in the United States are chemical abortions. No wonder the companies that make chemical abortion drugs applaud the FDA’s elimination of any meaningful safety requirements for selling these drugs.

The FDA’s recent action, moreover, is only the latest move in a series of unlawful decisions involving chemical abortions. In December 2021, the FDA permanently removed the in-person dispensing requirement, allowing virtual clinics to proliferate. These clinics consult with women by video, phone, or even online questionnaires and then mail them chemical abortion drugs.

The removal of the in-person dispensing requirement is reckless. Chemical abortions can result in complications like severe bleeding, infections, and the inability to carry later pregnancies to term. They are especially dangerous for women who are further along in their pregnancies than they realize or who have ectopic pregnancies. Both gestational age and ectopic pregnancies are diagnosed pursuant to an ultrasound. And yet, the FDA has permanently removed the requirement that an abortion provider even meet with a pregnant woman at all and now allows the chemical abortion drugs to be dispensed based on nothing more than an online questionnaire.

Studies show that one in five women who undergo a chemical abortion will suffer a complication and require further medical attention.

According to a new lawsuit filed on behalf of four medical associations and four frontline doctors by Alliance Defending Freedom, the FDA’s approval of chemical abortion drugs has been illegal all along. ADF argues that the FDA failed to protect American women “when it chose politics over science and approved chemical abortion drugs for use in the United States.” The FDA initially rushed the approval of these drugs using a procedure that required it to find that the drugs were necessary to protect against “serious or life-threatening illnesses.”

Thus, the only way the FDA could have approved chemical abortion drugs at all was to say that pregnancy is a “serious illness.” It is not. Further, to approve any drug the FDA must find that it has a “meaningful therapeutic benefit” over existing treatments. Yet the only so-called “benefit” of chemical abortion is the termination of the life of an unborn child. Further, these drugs have a complication rate four times higher than surgical abortion. Indeed, studies show that one in five women who undergo a chemical abortion will suffer a complication and require further medical attention. In fact, the FDA failed to adequately study the safety of the drugs under their labeled conditions of use and refused to study this hormone-blocking regimen on teenage girls going through reproductive development—despite being required to do so.

For pro-abortion activists, the FDA’s actions do not go far enough. These advocates say they will not be content until the federal government mandates abortion access in all fifty states. These arguments and the FDA’s actions illustrate the importance of the Supreme Court’s historic decision in Dobbs v. Jackson Women’s Health Organization. Where abortion is illegal, pharmacies may not dispense chemical abortion drugs. Even in states where some abortions remain legal, states may protect women’s health by imposing common-sense safety requirements like in-person dispensing by physicians.

The FDA’s approval of chemical abortion drugs and its continual removal of safety requirements for chemical abortions place politics above women’s health. They make it clear that—at least under the current administration—calls to value unborn life and to protect the safety, health, and welfare of mothers fall on deaf ears. For the foreseeable future, protecting maternal health and the most vulnerable falls to the states.

Editor’s note: The author works for Alliance Defending Freedom and is part of the legal team challenging the FDA’s approval of chemical abortion drugs


Erin Hawley

Erin Hawley is a wife, mom of three, senior counsel at Alliance Defending Freedom, and a law professor at Regent University School of Law.


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