The availability of a medication that safely and effectively terminates pregnancies (Mifeprex) has become a central battle line over access to abortion services ever since the June 2022 Dobbs ruling by the US Supreme Court overturning the constitutional right to abortion care.
Several lawsuits have been filed challenging various aspects of FDA’s approval of the drug Mifeprex in 2000 and subsequent changes to the limitations in the packet insert that the FDA approved in 2016, 2021 and 2023.
At the heart of these cases is the FDA’s authority to approve drugs, whether the FDA followed the statutory authority Congress have the agency, whether FDA followed the Administrative Procedures Act as they made their decisions, whether courts can reverse the FDA’s decisions, and whether states can impose additional restrictions beyond what the FDA requires.
Q & A: Implications of Two Conflicting Federal Court Rulings on the Availability of Medication Abortion and the FDA’s Authority to Regulate Drugs
The core case, which was decided in favor of the Plaintiffs in a Texas Federal District Court last week in Alliance for Hippocratic Medicine (AHM) v. FDA challenged FDA’s decision to approve mifepristone (Mifeprex). Plaintiffs argued that the FDA didn’t follow Congress’ guidelines for approving the drug and contending FDA didn’t promptly respond to petitions to review the approval as required by the Administrative Procedures Act.
The plaintiffs also argue that FDA’s April 2021 decision to exercise ‘enforcement discretion’ regarding the dispensing of Mifeprex through the mail is illegal because mailing the drug is in violation of the 1873 “Comstock Act”, which prohibits the mailing of any medication used for abortion (the Comstock Act has never been repealed and is still on the books).
Mifeprex Regulatory Timeline
- September 2000: FDA approved Mifeprex for the medical termination of pregnancy through 49 days’ gestation. FDA imposed conditions on the use of the drug that healthcare providers needed to follow to prescribe the drug and restricted how it could be distributed.
- August 2002: The “American Association of Pro-Life Obstetricians and Gynecologists” and “Christian Medical& Dental Associations and Concerned Women for America” submitted a petition requesting FDA revoke approval of Mifeprex.
- March 2016: The FDA denied the 2002 AAPLOG petition requesting to revoke approval of Mifeprex. Note: The Administrative Procedures ACT requires FDA to respond to petitions in 365 days.
- March 2016: FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice, approving the drug for medical abortions for up to 10 weeks of pregnancy.
- March 2019: AAPLOG and ACOP submitted a petition to FDA asking the agency to “restore and strengthen elements of the Mifeprex regimen and prescriber requirements approved in 2000,” and “retain the Mifeprex [REMS], and continue limiting the dispensing of Mifeprex to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.”
- April 2020: The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) sent a letter urging FDA to suspend enforcement of the in-person dispensing requirements of the Mifeprex.
- April 2021: FDA responded to the letter from ACOG and SMFM, stating that (during the COVID-19 public health emergency) they “would exercise enforcement discretion with regard to dispensing of Mifeprex . . . through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.
- In December 2021 the FDA denied their request to restore the prescribing requirements approved in 2000 and to limit dispensing (for both Mifepristone and Misoprostol) in person.
- January 2023: FDA removed the in-person dispensing requirement for Mifepristone.
Texas Case Ruling
By now you know by now that the judge in the Texas case ruled in favor of the plaintiffs and found that Mifeprex was improperly approved stating:
“Accordingly, the Court hereby STAYS the effective date of FDA’s September 28, 2000, approval of mifepristone and all subsequent challenged actions related to that approval — i.e., the 2016 Changes, the 2019 Generic Approval, and the 2021 Actions.”
The ruling is over 100 pages long and there are many aspects to it, but at the core the judge stayed the 2000 approval of Mifeprex because he believes the FDA:
- Ignored the petition to review the 2000 approval of the drug for over sixteen years, even though the law requires an agency response within 180 days;
- Inappropriately approved the drug under an emergency provision called Subsection H, an accelerated approval process for drugs to treat serious or life-threatening illnesses that provide therapeutic benefit over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)”; and
- Didn’t follow proper procedures and properly consider safety evidence when they changed the label and other prescribing and use criteria in 2016.
The court also said FDA’s decision to:
“… exercise enforcement discretion with regard to dispensing of Mifeprex through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber” because that decision is in violation of the 1873 “Comstock Act”.
That would mean the drug could not be mailed to patients seeking a medication abortion in areas without access to that care.
Washington State Case Ruling
Later in the week, the State of Washington Circuit Court issued a conflicting opinion shortly after Kacsmaryk’s decision with a completely opposite opinion:
“Pursuant to Federal Rule of Civil Procedure 65(a), irrespective of the Northern District of Texas Court ruling or the Fifth Circuit’s anticipated ruling, Defendants and their officers, agents, servants, employees, attorneys, and any person in active concert or participation, are PRELIMINARILY ENJOINED from altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States and the District of Columbia.”
U.S. Supreme Court Stay
The week closed out with the U.S. Supreme Court put a hold on the Texas case ruling through next Wednesday. It’s unclear what will happen next, but the conflicting opinions put FDA in an untenable position – increasing the likelihood that the US Supreme Court will accept this case on an expedited bases to resolve the conflict.