Will the Supreme Court Make Mifepristone Available in All Fifty States?
By Randall K O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. This appears in the October edition of National Right to Life News. Please share this valuable information from the “Pro-Life Newspaper of Record” with your family and friends.
By now, it is likely you’ve heard about at least one of the abortion pill cases now working their way through the courts. The truth is, there are several, and it can be hard to tell them apart or to understand the different, but related issues involved.
Given that they may determine the availability of mifepristone in the United States, even in states where legal protections exist for the unborn, a brief review of these cases and the issues involved may prove valuable.
Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (AHM v. FDA)
Probably the best known of these cases, this one involves a group of pro-life doctors who challenged the legality of the FDA’s original September 2000 approval of mifepristone and subsequent modifications made to the protocol in the years that followed. It also challenged the agency’s approval of the generic version that occurred in 2019.
We have previously offered extensive analysis of this case elsewhere and so will only offer a brief review of the relevant issues here.
AHM doctors asserted that the FDA violated its own procedures in approving mifepristone, using an accelerated process reserved for drugs offered to treat “serious” or “life-threatening illnesses.” Pregnancy was not a “life threatening illness” the doctors pointed out, and thus the FDA was not justified in cutting corners and accepting incomplete test results that nevertheless showed that the drug was dangerous.
The FDA approved the drug anyway, acceding to the wishes of the Clinton administration and the abortion lobby. They did, however, add certain restrictions on who could prescribe the pills (only certified physicians) and conditions under which mifepristone and its accompanying prostaglandin could be prescribed (given in three in-person visits, to women no more than 49 days after their last menstrual period, availability of emergency treatment, etc.).
The original distribution restrictions were officially made part of Risk Evaluation and Mitigation Strategy (REMS) regulations the FDA imposed on mifepristone in 2011. REMS are limits the agency imposes on drugs it believes come with “serious safety concerns.”
The FDA ignored evidence of deaths and injuries (and missing data of the same) in making changes to the REMS in 2016 and 2021. In those, the FDA dropped required visits, extended the gestational cut off, eliminated required reporting of non-lethal adverse events, and expanded the types health care personnel authorized to prescribe the drug.
This eventually culminated in the FDA’s formal decision in early 2023 to allow online ordering and mailing of the pills and the authorization for distribution of the drugs by pharmacies.
AHM doctors pointed out that the FDA made these changes without clear scientific evidence that these modifications were safe.
AHM brought this case before the U.S. District Court in Texas on November 18, 2022 and Judge Matthew Kacsmaryk ruled in their favor, granting a temporary injunction suspending approval of mifepristone on April 7, 2023, but delaying his ruling until higher courts could review the case.
The Fifth Circuit gave the case a full hearing on May 17, after a series of emergency appeals that went all the way to the Supreme Court kept the approval temporarily in place.
In its August 16, 2023 decision, the Fifth Circuit said that AHM’s complaint about mifepristone’s approval had been filed too late and so that approval and that of the generic would stand. But it agreed that modifications the FDA had made to the protocol in 2016 and 2021 had not been properly studied or justified. That meant gestational limits would return to what they were in the beginning (7 weeks after a woman’s last menstrual period), prescriptions would be limited to certified doctors, and pills could only be dispensed at health care facilities (i.e., no pills by mail order or telemedicine).
Implementation of that ruling was put on hold until the Supreme Court is able to hear appeals.
The Biden Justice Department is appealing the decision on behalf of the FDA, as is Danco, mifepristone’s distributor. Their main arguments are that the drug has been thoroughly tested and found safe and effective and that pro-life doctors, despite their sharing a troubling list of case histories of injured mifepristone patients, somehow lack “standing” in that they do not prescribe the pills and have therefore not suffered any injury.
Though expected to weigh in on the case, the Supreme Court has yet to indicate a timeline.
Washington v. U.S. Food and Drug Administration (WA v. FDA)
In this case, several Democrat State Attorneys General filed suit in federal district court in Washington state on February 23, 2023 against the FDA, challenging remaining restrictions on mifepristone and demanding that the agency keep the drug on the market.
Those filing the case were the states of Washington, Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and the District of Columbia.
Abortion advocates were upset that what was supposed to be an extensive review of restrictions on the drug, the agency had only relaxed, but not eliminated distribution rules.
Though the FDA had eliminated the in-person distribution requirement and allowed pharmacies to stock and sell the drug, the agency maintained that the certification system was still necessary because of risks and dangers still associated with use of the pill.
This means that, even now, prescribers (and now participating pharmacies) have to certify that women get the pills from someone who can ascertain gestational age (the pills’ effectiveness decreases the older the child), diagnose ectopic pregnancy (the pills do not work in this instance), and can treat or refer the woman for qualified medical help should hemorrhage or some other complication arise. All this also requires paperwork signed by both patient and prescriber.
The state attorneys general argued that mifepristone had already been shown to be safe and was being unfairly singled out for harsh, unnecessary restrictions, saying the agency was exceeding its statutory authority. They also wanted the judge to legally enjoin the FDA from taking any action to remove the drug from the market or otherwise limit its availability.
On April 7, 2023, within an hour of Judge Matthew Kacsmaryk’s ruling, District Judge Thomas O. Rice issued his own ruling.
While rejecting requests to jettison distribution and certification requirements entirely, Judge Rice did agree that, at least within the states bringing the suit, the FDA could not alter or reduce the regulations on mifepristone further, essentially guaranteeing the drug’s continued availability whatever else the agency or federal government did.
Litigation in the Washington case is ongoing.
GenBioPro, Inc. v Sorsaia
Filed January 25, 2023 in federal district court in West Virginia, this case was brought by the generic manufacturer of mifepristone challenging the authority of the state to prohibit the sale and use of a drug that the FDA had approved for marketing and ruled “safe and effective.”
West Virginia was one of those states which passed new abortion legislation after the Dobbs decision. Their Unborn Child Protection Act, passed September 13, 2022 and became effective upon passage, providing full legal protection for unborn children, limiting abortion to cases of ectopic pregnancy, medical emergency, or circumstances of sexual assault (through 8 weeks for an adult, through 14 weeks if a minor) if reported to the police.
GenBioPro filed its complaint shortly after that law went into effect. It sued the state’s attorney general, Patrick Morrisey, and Mark Sorsaia, the prosecuting attorney of Putnam County. GenBioPro said West Virginia was causing the generic manufacturer “significant, “ongoing economic injury” by impeding their ability to sell a legal product in their state. It further claimed that FDA determination of the pill’s worthiness for markets trumped whatever limits West Virginia placed on the drug.
On August 24, 2023, District Judge Robert James dismissed most of GenBioPro’s complaints, saying states, particularly after Dobbs, were within their rights to limit the sale of “goods” – in this case, abortion or abortion pills – in the interest of “public health and morality”
The judge did, however, permit GenBioPro’s challenge to the state’s prohibition on telemedical abortion to go forward. The court said that in the limited situations where the state continued to allow abortions under the new law (cases of ectopic pregnancy, medical emergency, reported cases of sexual assault), it could not “dictate[s] the manner in which mifepristone may be prescribed.” That, said judge Chambers, “is a determination Congress has allocated to the FDA.”
Given the rarity of these cases (medical emergency, sexual assault, etc.) and the unlikelihood of this method being the best method to use emergency conditions mean this caveat may not amount to much legally.
Though GenBioPro has said they are looking to see what to make of the judge’s ruling on telemedicine, neither GenBioPro nor the state of West Virginia have filed an appeals at this point
Bryant v. Stein
In this case, Chapel Hill abortionist Amy Bryant filed suit February 25, 2023 in federal district court in North Carolina challenging state regulations on dispensing mifepristone, saying they were more stringent than conditions imposed by the FDA and thus not legal.
Filed shortly after the FDA loosened REMS regulations on mifepristone–allowing the abortion drugs to be sold in pharmacies and shipped by mail without an office visit– Bryant complained that state rules in North Carolina requiring that mifepristone only be provided in person by a physician, and from a certified facility with required counseling (on risks and alternatives) and a 72 hour waiting period were in conflict with federal standards.
In such circumstances, Bryant argued, federal law should preempt state law, because Congress gave the FDA, not the state, the ultimate authority to determine the appropriate conditions and restrictions involved in the prescription and distribution of drugs like mifepristone.
The defendant named in the suit, North Carolina Attorney General Josh Stein, is a Democrat who has publicly sided with Bryant, the plaintiff, leaving two Republican legislators, Phil Berger, President pro tempore of the North Carolina Senate, and Tim Moore, Speaker of North Carolina’s House of Representatives, to defend and represent the state’s interests in enforcing the law.
That case has not yet been heard, though it raises similar issues to those addressed in West Virginia in GenBioPro v. Sorsaia.
Summing up for the Supreme Court?
Of these four cases, the first, AHM v. FDA is the one that is the most substantive, the farthest along in the process and most likely headed for the Supreme Court, given that both Danco, the pill distributor, and the Justice Department have already made direct appeals to the nation’s highest court.
It may be a matter of days, weeks, or even months before the Supreme Court announces whether it will take up the matter in the coming term. If it decides to take one or more of these cases, it would be heard sometime between this fall or next year’s spring. That would yield a ruling on the case at the height of next year’s political season and make it a flash point in summer campaigns.
It is not inconceivable that the Court could wait for all these cases to proceed on their full course or could decide to address concerns from all four cases in one ruling.
Though abortion is the issue that draws the attention of many, there are multiple legal and constitutional issues involved, making it hard to predict where even a Dobbs sympathetic court would go.
Dobbs should have settled the right of people through their own elected representatives to make their own decisions with regard to the legality of abortion in their states. How much and in what ways does this apply when states are making rules about whether or under what conditions abortion pills may be available in their states?
Some see this as yet another chapter in the ongoing constitutional dispute over state versus federal authority. Here, that would involve a state’s ability to set and enforce rules related to the safety and use of various products or drugs that supersede federal standards, particularly when the federal government has created and empowered a specific agency, the FDA, to do so.
This is one of the approaches favored by the abortion industry.
Whether the FDA has appropriately fulfilled its legal mandate with regard to this particular drug or violated its statutory responsibilities by politically favoring this drug, as alleged in the AHM case, is another open issue.
One critical legal issue raised in a couple of these cases is the meaning and application of the Comstock Law. That federal law, which has been in place since 1873, made it illegal to mail any “obscene, lewd, or lascivious” materials, like pornography, or any article or thing “intended for the prevention of conception or procuring of abortion.”
Though some applications of that law, such as its prohibitions on the mailing of pornography or contraceptives, have been modified, reinterpreted or overruled in the 150 years since its passage, the section on the mailing of abortifacients has never been repealed, despite some efforts to do so.
The FDA’s recent protocol modifications allowing the shipping of these pills to pharmacies and the mailing of mifepristone to women’s homes appear to be a clear and direct violation of that still active statute.
If they take any of these cases, the justices of the Supreme Court may deal with all these issues or choose to narrowly focus on just one.
In any case, the courts will probably have a lot to say about the availability of mifepristone in the coming months.