Q & A: Implications of Two Conflicting Federal Court Rulings on the Availability of Medication Abortion and the FDA’s Authority to Regulate Drugs
On April 7, 2023, two conflicting rulings on the provision of mifepristone, the drug used for medication abortion, were issued by two separate federal court judges, one in Texas and one in Washington State. Judge Mathew Kacsmaryk, the judge in the US District Court for the Northern District of Texas Amarillo Division, issued a preliminary injunction in the case, Alliance for Hippocratic Medicine v. FDA, blocking the FDA’s approval of mifepristone dating back to 2000. The judge has stayed his decision for seven days to give the FDA time to appeal, but the ruling effectively impacts the entire nation and would effectively revoke the FDA approval granted to mifepristone in 2000.
On the same afternoon, Judge Thomas O. Rice from the United States District Court in the Eastern District of Washington ruled in a case that was filed by the Oregon and Washington Attorneys General joined by 16 other Attorneys General. The AGs are challenging the FDA’s decision to impose restrictions on prescribing and dispensing mifepristone through the Risk Evaluation and Mitigation System (REMS), claiming the restrictions on the dispensing of the drug imposed by the FDA are unnecessary and limit its availability. This ruling orders the FDA to maintain the current availability of mifepristone in the 17 states and DC, the plaintiffs in this case.
As a result, the FDA has conflicting orders: to suspend its approval mifepristone on one hand and not to alter its approval effective January 2023, on the other. Because these two federal court rulings conflict, the Supreme Court could be called upon to resolve this conflict and decide the merits of both cases. This Q&A summarizes some of the key issues related to these rulings.
Who are the plaintiffs that are suing to block medication abortion?
The plaintiffs in the Texas case, Alliance for Hippocratic Medicine (a newly formed anti-abortion advocacy coalition); the American Association of Pro-Life Obstetricians and Gynecologists; the American College of Pediatricians; and the Christian Medical and Dental Associations, as well as three individual doctors challenged the FDA’s approval of mifepristone, one of the drugs used in medication abortion. The plaintiffs are challenging the FDA’s approval process and subsequent modifications of the conditions for dispensing mifepristone (known as REMS) as being beyond the FDA’s authority. The plaintiffs also contend that an 1873 anti-obscenity law, the Comstock Act, prohibits the mailing of any medication used for abortion (for details on the case see: Legal Challenges to the FDA Approval of Medication Abortion Pills). The Judge’s ruling in this case directs the FDA to suspend its approval of the mifepristone while the litigation continues, but gives the FDA seven days to appeal the case to the 5th Circuit before the order takes effect. This ruling would block the sale and distribution of mifepristone in the entire country, and would also block access to the drug in states where abortion is legal and protected.
What is the lawsuit filed by Democratic State Attorneys General?
The Oregon and Washington Attorneys General joined by 16 other Attorneys General are also challenging the FDA’s decision-making about mifepristone, but rather than challenging the FDA approval process, the plaintiffs are calling into question the FDA’s decision to impose restrictions on prescribing and dispensing mifepristone through the Risk Evaluation and Mitigation System (REMS). As of January 3, 2023, mifepristone can only be prescribed by a certified provider and the drug can only be provided by a certified pharmacy or clinician. The judge in this case has issued a preliminary injunction blocking the FDA from changing any rules that would impact the availability of mifepristone in states bringing the lawsuit (WA, OR, CO, CT, IL, NV, AZ, RI, OR, DE, MI, NM, VT, HA, MD, ME, MN, PA, and DC).
What is medication abortion?
The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol, which are FDA approved. Mifepristone, also known as the abortion pill, or RU-486 is sold under the brand name Mifeprex and through a generic manufactured by GenBioPro in the United States. The FDA has found that medication abortion is a safe and highly effective method of pregnancy termination. When taken up to 70 days of pregnancy, the medication abortion regimen successfully terminates the pregnancy 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%). Mifepristone was first approved by the FDA in 2000, and by 2021, over half of abortions in the US were medication abortions. Despite being available for medication abortion for over two decades, there is still considerable confusion about the drug in this country. A KFF poll conducted in January 2023 found that about half of the public was unsure as to whether medication abortion is legal in their state, including four in ten (41%) women ages 18 to 49 and half of women living in states where abortion is legal.
A little-known fact is that mifepristone, under the brand name Korlym, was also FDA-approved in 2012 without any REMS to manage blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. Korlym is a higher dose of mifepristone than Mifeprex and is taken daily.
There is also a different medication abortion protocol using misoprostol alone that is more commonly used internationally. Misoprostol is frequently used in obstetrics and gynecology for procedures like the medical management of miscarriage, induction of labor, cervical ripening before surgical procedures, and the treatment of postpartum hemorrhage. While misoprostol is FDA approved for many medical uses, it has not been FDA approved for abortions, meaning it is used “off label” for this purpose in the US. The regimen is also recommended for up to 70 days (10 weeks) of pregnancy. Research has shown the misoprostol-only regimen to be a safe and highly effective method of pregnancy termination, however it may result in a higher incidence of side effects. Some U.S. telehealth organizations have been providing the misoprostol-only regimen as an option for medication abortion for several years.
Will medication abortion continue to be available?
It is too soon to tell what the impact will be on the availability of medication abortion. It’s not known how the FDA will act in response to the two conflicting rulings. The FDA approves drugs for the whole country and does not vary its approval by state. If the FDA is forced to suspend its approval of mifepristone, some clinics may respond to this ruling by switching from the mifepristone/misoprostol regimen to using a higher dose of misoprostol alone.
What is the next step in the litigation?
Hours after Judge Kacsmaryk’s ruling, the FDA filed a notice of appeal to the US Court of Appeals for the 5th Circuit and Attorney General Merrick Garland said the government would request a stay to block this ruling while the appeal is considered. If the 5th Circuit does not grant this request, the FDA is likely to appeal immediately to the Supreme Court of the United States to block the ruling during the appeal process. If the case is appealed but the courts do not provide a stay, then the distribution of mifepristone could be halted across the nation pending the final outcome of the case.
The FDA may not appeal Judge Rice’s decision as it directs the FDA to keep the status quo. The Attorneys General who brought the case may appeal the decision to the 9th Circuit to seek an injunction to block the enforcement of the REMS approved in January 2023.
As both of these cases involve the FDA approval and provision of mifepristone, it is likely that if they reach the Supreme Court, it will review the cases together.
Are there other lawsuits that involve mifepristone?
Some are questioning how the new state authority to regulate or ban abortion intersects with the Federal FDA’s authority to regulate drugs. There are currently two cases in federal court challenging state abortion prohibitions and restrictions on federal preemption grounds. The maker of a generic mifepristone medication, GenBioPro, Inc., is challenging West Virginia’s total abortion ban, and an ob-gyn, Dr. Amy Bryant, is challenging the abortion restrictions in North Carolina, which include requirements that mifepristone be dispensed in person by a physician following a state-mandated counseling session and a 72-hour waiting period. In both cases, plaintiffs argue that the FDA’s authorization and regulation of mifepristone preempt state law banning the use of the medication or regulating its use more strictly, and given this, enforcement of the state laws should be blocked. If these lawsuits are successful, people living in states where abortion is banned could access medication abortion.
What impact do these rulings have on the FDA’s approval of other drugs?
These rulings will likely have implications far beyond abortion, though it is still too soon to tell. Court challenges such as these could open the door for other actors to potentially sue to block the approval of existing or new drugs that may be considered controversial, such as vaccines or treatments for conditions that are at the crosshairs of so-called “culture wars.” Manufacturers may be reluctant to bring to market certain new drugs or treatments if they are concerned that a court ruling could block their approval in the future.