With the U.S. Food & Drug Administration (FDA) this week finalizing a rule-change that allows brick-and-mortar pharmacies to dispense mifepristone online, if permitted under state law, a lawsuit challenging the regulatory review and safety of “abortion pills” bound for trial in the Texas Panhandle assumes added significance.
Alliance Defending Freedom filed a 113-page lawsuit on Nov. 18 in the U.S. District Court for the Northern District of Texas in Amarillo on behalf of the Alliance for Hippocratic Medicine and an array of other organizations and individuals, arguing the FDA did not properly approve mifepristone for terminating pregnancies.
The suit seeks a preliminary junction suspending the prescription of “mifepristone and misoprostol as FDA-approved chemical abortion drugs” while the legal challenge works its way to trial, perhaps as soon as this spring.
Mifepristone is used in tandem with misoprostol to terminate pregnancies up to 10 weeks after conception. Mifepristone blocks absorption of progesterone, a nutrient, stopping a pregnancy from progressing. Misoprostol, taken 24 to 48 hours later, induces miscarriage.
At least half the abortions that occur in the United States are facilitated through the mifepristone-and-misoprostol protocol, according to analysis by the Guttmacher Institute, a research and policy organization that supports abortion rights.
The FDA approved mifepristone for “medication abortion” more than two decades ago, in 2000. The U.S. Department of Health and Human Services (HHS), American Medical Association, and American College of Obstetricians and Gynecologists maintain mifepristone is safe.
A Chosen Court of First Resort
The case challenging that determination will be heard by U.S. District Judge Matthew J. Kacsmaryk, appointed to the bench by President Donald Trump, who issued the December injunction preventing the Biden administration from terminating the ‘Remain in Mexico’ program.
In that order, he agreed to hear HHS’s argument that suspending the rule is not a “proper remedy” until there is resolution of the ongoing lawsuit, also filed by Alliance Defending Freedom (ADF), a conservative Christian legal advocacy group based in Scottsdale, Ariz.
As of Jan. 5, Kacsmaryk had not has scheduled oral arguments on ADF’s motion for a preliminary injunction halting doctors from prescribing mifepristone.
He has, however, set a Feb. 10 deadline for parties to file briefs in ADF’s lawsuit challenging the alleged “unlawful approval of chemical abortion drugs and subsequent elimination of the safeguards necessary to protect women and girls.”
“The FDA has once again prioritized politics over the health, safety, and welfare of women and girls,” ADF Senior Counsel Julie Blake said in emailed statement to The Epoch Times. “Instead of trying to promote the widespread distribution of dangerous chemical abortion drugs, the FDA should be removing them from the marketplace or, at minimum, strengthening the safeguards for those women who take these drugs.”
Rule-Change ‘Bolsters Strength’ of Suit
In December 2021, the FDA allowed doctors to issue telehealth, or online, prescriptions for mifepristone and misoprostol.
Under the Jan. 3 rule-change in the FDA’s mifepristone Risk Evaluation and Mitigation Strategy (REMS), retail pharmacies can be federally certified to sell mifepristone to those with online prescriptions—that is, if medical abortions aren’t banned, and if doctors are allowed to prescribe abortion drugs online, under state laws.
A same-day U.S. Department of Justice legal opinion determined “mailing of pregnancy-terminating drugs does not violate” a 150-year-old federal law prohibiting the U.S. Postal Service from conveying anything “the sender intends … to be used unlawfully.”
ADF’s lawsuit alleges the FDA did not adequately conduct safety studies and termed pregnancy an “illness” to “accelerate approval” mifepristone, also known as RU 486.
“Our lawsuit seeks to compel the FDA to do right thing and protect women from these dangerous drugs,” Blake said. “The FDA’s latest action just bolsters the strength and importance of our case.”
Study: ‘Short-Term Adverse Events More Likely’
According to a study by University of Toronto researchers published Jan. 3 in the Annals of Internal Medicine, while “short-term adverse events are more likely” for women undergoing first-trimester abortions using mifepristone-misoprostol than for those who opt for “procedural” induced abortions, the drugs are safe.
The study included two “comparisons.” One comparison studied outcomes of 39,856 women dispensed mifepristone-misoprostol as outpatients and 65,176 women who underwent “procedural” abortions at 14 weeks of gestation or earlier.
“Short-term adverse effects”—or SAEs—occurred in 3.3 per 1,000 mifepristone-misoprostol abortions and 1.8 per 1,000 procedural abortions, according to the study.
The second comparison included 39,856 women prescribed mifepristone-misoprostol and 8,861 women “undergoing ambulatory hospital-based procedural” induced abortions at an estimated nine weeks of gestation or less.
“There was no significant difference seen in SAEs” which occurred in 3.3 per 1,000 women using the drugs, and 3.4 per 1,000 women undergoing a surgical procedure, the study cites.
“Although short-term adverse events occur more often after mifepristone-misoprostol Induced abortions than procedural induced abortions, the risk for serious adverse outcomes is very small,” the authors wrote.
Post-Roe State Laws Supersede FDA Rule
With the U.S. Supreme Court’s June 2021 decision overturning Roe v. Wade, abortion is now entirely regulated by states. At least 12 states right now ban drugs that induce “chemical abortions.”
Since the June decision, near-total abortion “trigger” bans, that include “chemical abortions,” have gone into effect in 12 states, including Texas, according to the Guttmacher Institute.
By the time state legislatures conclude 2023 sessions—45 convene by Jan. 18—that number could increase to at least 26, the institute projects.
Among states where lawmakers are expected to adopt near-total bans, including “chemical abortions,” is Florida, Iowa, Nebraska, Ohio, South Carolina, Indiana, Montana, North Carolina, Utah, Virginia, and Wyoming. In some of these states, such as Utah and Wyoming, the new laws will replace previous bans blocked by court rulings.
Susan B. Anthony Pro-Life America State Policy Director Katie Glenn said among her fears is the FDA’s rule change and DOJ legal opinion could lead to “a doctor licensed to practice in San Francisco mailing chemical abortion pills to Minneapolis” to a patient via an online prescription.
“Most states don’t allow this. They have laws on the books that say you must see a licensed physician in-person to screen you, just like they would for any other treatment,” she told The Epoch Times. “The blue states don’t enforce their laws on the books.”
The danger, cited among claims in ADF’s suit, is “women aren’t getting instructions if they buy them online” on how to properly use the drugs safely, Glenn said.
“That is something we are taking to lawmakers and educating them about,” she said, adding even many who support abortion access question “if we should trust people who think it is a very good idea to buy drugs online.”
Glenn said Susan B. Anthony Pro-Life America is merely enforcing “good old-fashioned advice that mothers tell children: ‘Don’t take something if you don’t know what it is.’”
Muted Applause From Abortion Rights Advocates
The FDA’s rule-change was applauded by Pro-Choice advocates, including Democratic Michigan Gov. Gretchen Whitmer, who had been lobbying the FDA since December 2021 to remove restrictions on mifepristone.
“Today, it’s getting done,” Whitmer said in a Jan. 3 tweet. “What does this mean? Medication abortion will be available at pharmacies with a prescription. A great step forward for reproductive freedom.”
University of Pittsburgh John E. Murray Faculty Scholar in Law and Bioethics professor Greer Donley, who frequently writes about legal issues related to abortion debate, said in a series on Jan. 3-4 tweets that Pro-Choice advocates “should be celebrating this FDA announcement too much.”
The FDA announcement “does nothing more than flesh out the FDA’s decision from Dec. 2021,” she wrote. “There is not much new here & it’s frustrating it took over a year to get the details.”
The FDA pharmacy certification is unneeded, Donley wrote. “When it removed the in-person dispensing requirement in 2021, it could have just let any pharmacy dispense mifepristone as all other drugs. I’m glad it looks like the policy won’t be too burdensome, but it’s unnecessary,” she said.
Donley said what impact the rule-change has will depends on whether “brick-and-mortar pharmacies get on board, and I’m not optimistic the big chains most Americans rely on will become certified.”
A CVS Health spokesman said Jan. 3 the drugstore chain was reviewing the FDA rule-change “to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy.”
Walgreens issued a statement that said it was also reviewing the FDA’s regulatory change. “We will continue to enable our pharmacists to dispense medications consistent with federal and state law,” it said.
