Abortion Pills Face Uncertain Future After Dobbs
6.12.2023
After Dobbs v. Jackson Women’s Health Organization made abortion unavailable in many states, an increasing number of patients have turned to the drugs mifepristone and misoprostol for medication abortions. But mifepristone is facing a challenge to its long-standing Food and Drug Administration approval.
At a virtual webinar sponsored by the Women in Law Section, panelists discussed the history of medical abortion drugs and their potential future as Alliance for Hippocratic Medicine v. FDA works its way through the higher courts.
The panelists included:
- Whitney C. Cloud, partner at DLA Piper.
- Linda C. Goldstein, senior counsel at the Center for Reproductive Rights.
- Jenna Lauter, Equal Justice Works fellow at the New York Civil Liberties Union.
- Kirsten Moore, director of the EMAA Project,
Josephine Reina, associate attorney at Tanenbaum Keale, moderated the discussion.
In 2000, the FDA approved the two-drug regimen of mifepristone and misoprostol for abortions up to seven weeks. (This was later expanded to ten weeks.) Mifepristone blocks the hormones necessary to sustain a pregnancy, and misoprostol starts contractions to pass the pregnancy.
“It has an incredibly compelling safety track record,” said Moore. “More than 5 million people have used it in the U.S. alone. And the serious adverse event rate is less than 0.05%.” She added that even during an adverse event, a patient would have to take more misoprostol or go to a doctor to complete the abortion.
Moore also noted that the American College of Obstetricians and Gynecologists regards mifepristone and misoprostol as the “gold standard” for the treatment of early miscarriages.
When the FDA first approved mifepristone, only physicians could prescribe it and patients were required to get the drug from a clinic and take the first pill there. These requirements were loosened over time, a process that accelerated as the pandemic made it advisable to dispense the medication via telehealth and mail it to patients.
But the legal status of in-person pharmacy dispensation of mifepristone is not consistent across all states. “It’s complicated because FDA evaluates the safety of drugs,” said Moore. “States regulate the practice of medicine and the practice of pharmacy.”
The data collected during the pandemic supported the use of virtual prescribers and mail-order pharmacies for mifepristone and misoprostol, as it proved that it was equally as effective and safe as the traditional distribution model. Patients even received the drugs sooner, as they did not have to wait for an appointment at a physical location.
Lawsuit Challenges The Use of Mifepristone
Anti-choice organization Alliance for Hippocratic Medicine sued the FDA late last year, arguing that the initial study in 2000 was insufficient to establish the safety of mifepristone, and that mailing the drug violates the Comstock Act, which criminalizes mailing “obscene materials.”
The case was filed in the United States District Court for the Northern District of Texas in Amarillo, where every civil case is heard by one judge.
“That judge is Matthew Kacsmaryk, a Trump-appointee who was general counsel to a conservative religious advocacy group before his appointment,” said Goldstein. “The plaintiffs asserted venue in Amarillo because the Alliance for Hippocratic Medicine was incorporated in Amarillo in August of 2022, which notably was after the Dobbs decision and a mere three months before the case was filed.”
Three other anti-abortion groups and four anti-choice doctors joined the Alliance for Hippocratic Medicine in the lawsuit.
“None of the plaintiff-physicians prescribe mifepristone to their patients for abortion care,” said Goldstein. “The physicians claim to have treated patients who were prescribed mifepristone by other physicians and suffered complications. None of these physicians have identified any harm that they personally suffered as the result of providing that care.”
There is also concern that if this case is upheld, it could open the floodgates for challenges to all other FDA approvals, including misoprostol, and vastly expand who can bring such lawsuits. “The FDA’s standing as an agency is one of the most revered agencies,” said Cloud. “So this is a really bold decision.”
On April 7, the District Court granted a preliminary injunction, suspending the FDA’s mifepristone approval. An emergency stay ruling from the Fifth Circuit unwound the District Court’s decision, restoring the mifepristone approval to old prescription, dispensation and timing standards it had in 2000.
The Supreme Court issued a stay on April 21, restoring mifepristone approval to what it was before the case was started as the litigation works its way through the courts.
The case went back to the Fifth Circuit, and arguments were heard on May 17. “It was very active questioning on both sides, but it is plain from the questions that the panel was very skeptical of the notion that FDA gets any kind of special deference for its scientific judgments,” said Goldstein. “And also very lenient towards the plaintiffs’ standing arguments.”
Lauter said New York State is bracing for restrictions on access to abortion medications and is stockpiling a five-year supply of misoprostol. In addition, New York will not help other states extradite or arrest someone for their involvement in abortion care and has passed laws to protect people providing and seeking abortions in the state.
“New York State cannot actually stop other states from initiating investigations and prosecutions,” said Lauter. “Nor can they make something legal in another state that state’s laws prohibit. So what the laws really do is they make sure that New York does not participate in hostile states’ efforts to punish care. And hopefully they throw some sand in the gears to make those investigations and prosecutions more difficult.”
The full webinar is available here.
