The U.S. Supreme Court has thrown open the once impenetrable blockade on state abortion regulations with its decision in Dobbs v. Jackson Women’s Health Organization that overturned Roe v. Wade in June 2022, and now the battle over do-it-yourself home abortions using abortion pills is heating up.
Abortion pills are responsible for approximately 50% of American abortions annually. Even as 19 states have issued various restrictions on how, when, and where physicians can prescribe and dispense abortion drugs, the U.S. Food and Drug Administration has loosened federal regulations on them in an attempt to make them easier to access.
The result is a patchwork of laws and regulations and the kind of uncharted legal territory that keeps federal judges up at night.
There are two drugs that are part of the FDA’s approved regimen for chemical abortion: mifepristone and misoprostol. GenBioPro, which manufactures mifepristone, has sued the state of West Virginia over its restriction on the use of that drug. Its argument: The FDA’s approval and regulation of the pill preempt the state law that outlaws it.
At the same time, an obstetrician-gynecologist in North Carolina has sued state officials in a challenge to that state’s requirements for prescribing mifepristone because the requirements go beyond what the FDA has required for sale and distribution of the drug.
The doctor argues, much like GenBioPro in the West Virginia suit, that the FDA has already regulated abortion pills in a way that accounts for their risks and that North Carolina cannot impose additional controls on top of what the FDA has already considered.
Unfortunately, North Carolina state officials are unlikely to get much support from their Democratic attorney general, Josh Stein. He has agreed with the plaintiff doctor, saying that the state’s pill restrictions are preempted by the FDA’s federal regulations.
Complicating things further is July guidance from the Biden administration allowing pharmacies to become certified to dispense mifepristone and directing them not to discriminate in filling prescriptions for abortion pills based on the pharmacist’s own views on abortion. The White House has claimed, “These changes seek to reduce the burden on the healthcare delivery system while ensuring the benefits of the medication outweigh the risks.”
It’s a move that has been roundly criticized by pro-life advocates as an attempt to turn retail pharmacies into abortion clinics. Some states like Florida have gone so far as to instruct state pharmacies not to dispense abortion pills because to do so would violate state law.
So, in a standoff between federal regulation and state law over the use of a drug designed to end unborn life, which prevails?
The litigation on abortion pills turns on a longstanding legal principle arising from the Constitution’s supremacy clause: a valid federal law (and that would include regulations that are properly promulgated to implement that law) preempts a clearly contradictory state law.
In the litigation over abortion pills, the preemption issue is particularly relevant because the FDA has concluded that mifepristone and misoprostol are “safe and effective” under certain conditions and, therefore, may be marketed.
But do these state laws clearly contradict federal law here? That is the critical question.
Few states have ever tried to fully ban an FDA-approved drug before now. But then again, no state has ever had the legal ability to restrict abortion in the way states now can (at least not since 1973, when Roe was decided).
While the general rule is that federal law trumps state law, the Constitution’s 10th Amendment dictates that states may exercise powers that are not delegated to the federal government or otherwise prohibited to the states.
These reserved powers include what is often called a general “police power” to provide for “[p]ublic safety, public health, morality, peace and quiet, [and] law and order.” These powers traditionally include state regulation of the medical profession. And after the Supreme Court’s ruling last term in Dobbs, states may now prohibit abortion.
While the general presumption is that federal law reigns supreme, that presumption likely does not apply when the historic police powers of the states—such as regulating the medical profession—are involved.
The result? State or local governments can regulate matters related to health and safety without violating the supremacy clause. And, as my Heritage Foundation colleague Tom Jipping and I have written, that means, with Roe v. Wade now overruled, the states may again exercise their traditional police power to restrict or prohibit abortion—including particular methods of abortion, such as by pill.
In a post-Roe world, therefore, the success of lawsuits like those against the abortion restrictions in North Carolina and West Virginia seem dubious at best.
In the West Virginia litigation, GenBioPro’s lawyers have argued that “a State’s police power does not extend to functionally banning an article of interstate commerce—the Constitution leaves that to Congress.”
True, except when there’s a federal law—the Comstock Act—on the books actually banning that particular article (abortion pills) from entering interstate commerce in the first place. My colleague and I have written on that, too.
One significant development looms large on the horizon. In fact, it might be the final say on whether or not abortion pills will continue to be FDA-approved at all.
The plaintiffs in a recent case filed in federal court in Texas—a coalition of national medical associations and doctors experienced in caring for pregnant and post-abortive women—are making a first-of-its-kind claim: The FDA never had the authority to approve the chemical abortion pill mifepristone when it did so in 2000.
The plaintiffs have requested that the court find the FDA’s approval of the pill and its years of subsequent loosening of restrictions on its use to be unlawful, arguing that the FDA ignored its mission to protect the public health by pushing mifepristone through its accelerated approval process and ignoring the relevant law and science governing chemical abortions to do so.
They have also requested that the court order the FDA to withdraw its approval of the drug. If that happens, the claims of those challenging state restrictions on the abortion pill will be anything but certain.
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