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Is the FDA all powerful?

Generic chemical abortion drug manufacturer seeks to reverse Dobbs


Bottles of the drug misoprostol sit on a table. Associated Press/Photo by Allen G. Breed

Is the FDA all powerful?
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Less than one year ago, the Supreme Court reversed Roe v. Wade, correcting one of the most damaging constitutional decisions of all time and returning the power to protect unborn life to the people’s elected representatives. Yet in a pair of coordinated federal lawsuits, GenBioPro, the manufacturer of the generic chemical abortion drug mifepristone, argues that the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization is meaningless. According to the drug manufacturer, the Food and Drug Administration has “exclusive authority” when it comes to chemical abortion and has mandated nationwide abortion access up through ten weeks gestational age.

But last year’s landmark Supreme Court decision suffers no such foolishness. The Dobbs decision explains over and again that the power to protect unborn life is restored “to the people and their elected representatives.” GenBioPro complains state laws protecting unborn children limit the company’s opportunity “to market, promote, and sell” mifepristone, and that the federal courts must override democratic judgments that unborn life is worthy of protection. In GenBioPro’s view, the FDA’s approval of mifepristone preempts any state law that protects life from abortion, even when those laws say nothing at all about mifepristone. The problems with GenBioPro’s argument are many.

First, GenBioPro misreads federal law. Nothing in the text of the Food Drug and Cosmetic Act (FDCA) suggests that Congress authorized the FDA to exercise such extraordinary power over one of the most contentious political issues of our day. Simply put, there is no federal policy supporting GenBioPro’s alleged right to sell as many chemical abortion drugs as possible nationwide. Rather, the FDCA has long been understood to set a federal floor on the approval of drugs, allowing complementary state regulations providing greater protections. It has never been interpreted to require nationwide access to any drug, much less one that takes innocent lives in violation of state law. The Dobbs Court was surely aware of the FDCA and yet held that states may protect unborn life “at all stages of development.”

Second, congressional legislation seeking to mandate nationwide abortion access has repeatedly failed. Indeed, Congress has protected life in several ways, by prohibiting certain abortions, refusing to allow federal taxpayer dollars to finance abortions, and prohibiting the mailing of abortion-inducing drugs and devices. Yet GenBioPro’s argument would allow a federal agency to enact the very regulatory program that Congress itself has repeatedly rejected.

Third, under separation-of-powers principles, federal agencies have only the powers given them by Congress. It is inconceivable that Congress handed over to a federal agency—without so much as mention of the word abortion—the authority to decide under what circumstances unborn babies should live and die.

No federal statute authorizes the FDA to preempt state laws protecting unborn life.

Indeed, the Supreme Court has repeatedly said that it expects Congress—and not federal agencies—to make significant policy decisions. Thus, when cap-and-trade legislation failed and the Obama administration sought to impose such regulation vis-a-vis the Environmental Protection Agency, the Supreme Court held that Congress had not clearly delegated the sweeping power to transform the nation’s energy grid to the agency. The Biden administration’s claim that the Occupational Safety and Health Act gave a federal agency the power to authorize a nationwide vaccinate-or-test mandate for some 80 million workers met a similar fate. In that case, the Supreme Court concluded that Congress had not clearly delegated such a consequential and significant question to a federal agency.

So too here. As the Supreme Court has long recognized, abortion involves profound moral and spiritual issues at the earliest stages of pregnancy. Because this issue is one of great significance, GenBioPro is required to point to clear congressional authorization for the FDA to regulate abortion. No such authorization exists.

Finally, GenBioPro’s claim fails under ordinary preemption principles, which recognize that the regulation of health and safety is a matter of state and local concern. The FDA cannot override these historical state police powers unless GenBioPro can prove that this was the clear purpose of Congress. Again, no federal statute authorizes the FDA to preempt state laws protecting unborn life.

In fact, the FDA’s purpose is limited to ensuring that federally approved drugs are “safe and effective.” State pro-life laws that limit abortion, on the other hand, do not second-guess the safety or efficacy of any drug; they prohibit the purposeful destruction of human life. That these laws are concerned with saving lives, not assessing the efficacy of any life-ending drug, renders the alleged federal-state law conflict illusory. As for laws that impose additional restrictions on mifepristone, those state regulations are complementary to the FDA’s purpose in promoting the safety of dangerous drugs.

GenBioPro is wrong that a nationwide right to sell chemical abortion drugs has long lain latent in the Food Drug and Cosmetic Act. The Dobbs decision reaffirms that this consequential social and political issue resides with the people, not with any federal agency, and certainly not with a drug manufacturer. That decision gives back to the people the power to protect unborn life, no matter how small or vulnerable, and nothing in the fact of mifepristone’s approval by the FDA says differently.

Editor's note: The author works for Alliance Defending Freedom and is serving as counsel to West Virginia and North Carolina in the GenBioPro lawsuits.


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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