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How a Lawsuit Against the FDA Could Change Abortion in the U.S.

The FDA faces lawsuit over approval of abortion pill.

Washington, DC USA May 3 2022: Protesters gather at the US Supreme Court after a report that the count will overturn Roe vs Wade, ending the constitutional right to abortion. Image: Drew Petrimoulx/Shutterstock

In November, the Alliance for Hippocratic Medicine (AHM) sued the FDA for approving mifepristone. As the most commonly used method of terminating pregnancy in the U.S., this lawsuit could seriously harm women’s health efforts.

The Lawsuit

On November 18, 2022, four national medical associations sued the U.S. Food and Drug Administration (FDA) for its decades-old approval of an abortion-inducing pill, mifepristone. The Alliance Defending Freedom and a private law firm introduced the suit in the United States District Court for the Northern District of Texas. On a related note, the Alliance also played a significant role in the Dobbs v. Jackson Women’s Health Organization case that led to the overturning of Roe v. Wade. This lawsuit is the latest challenge to abortion access in the U.S. following this case. Under the Administrative Procedure Act, the suit argues that the FDA’s approval and regulation of medical abortion is “in excess of the agency’s jurisdiction as well as arbitrary and capricious.” In other words, plaintiffs are requesting that the court order the withdrawal of mifepristone as an FDA-approved chemical abortion drug.

Judge Matthew Kacsmaryk, a federal judge appointed by former president Donald Trump, presides over the case. Kacsmaryk’s views are thought to be more conservative and driven by Christian values. He has made Texas “a legal graveyard” for policies of Biden’s administration, presiding over 95% of the civil cases brought in Amarillo, Texas. Kacsmaryk delayed the administration’s attempt to end the “Remain in Mexico” program in December. Additionally, he has overseen cases challenging vaccine mandates, the gender identity guidance issued by the U.S. Equal Employment Opportunity Commission, and the limits on using Covid-19 relief funds for tax cuts.

Fortunately, he has extended the lawsuit deadline to February 24. In preparation, he ordered Danco Laboratories, a company that makes mifepristone, to form its argument as to why the medication belongs on the U.S. market. The original filers of the lawsuit have until February 24 to reply.

Boston, MA, USA – June 24, 2022: Thousands demonstrated in Boston, hours after the Supreme Court of the United States overturned Roe V. Wade. Image: Maverick Pictures/Shutterstock

The Arguments

The Alliance contends that the FDA abused its authority in approving mifepristone through an accelerated approval process. Further, they claim that the FDA “failed America’s women and girls” with this accelerated approval. Though both were rejected, the Alliance has already filed two citizen petitions requesting the FDA add restrictions on mifepristone.

In response, the FDA argued that the approval of mifepristone came four years after its initial application. Additionally, the agency approved the pill as safe and effective based on extensive scientific evidence. And decades of experience have proven that the drug is safer than surgical abortion or childbirth. With this in mind, the FDA warns that removing mifepristone from the U.S. would result in worse health outcomes for patients relying on the pill to end a pregnancy.

“If FDA approval of mifepristone is revoked, 64.5 million women of reproductive age in the U.S. would lose access to medication abortion care, an exponential increase in harm overnight. This doesn’t include people who can get pregnant but do not identify as women—if we factor in that population, the number of people harmed is even higher.”

NARAL Pro-Choice America, New research for upcoming Alliance v. FDA lawsuit
medication abortion graph
Graph showing the percentage of U.S. abortions that are medication abortions yearly. Credit: Guttmacher Institute

In defense of the FDA, New York Attorney General Letitia James led a group of 22 attorneys general in filing a brief arguing that disregarding the FDA’s approval would have “devastating consequences” for women across the U.S. In response, Mississippi Attorney General Lynn Fitch and 22 Republican attorneys general filed a brief calling the FDA’s approval “deeply flawed.”

The Method

Combined with misoprostol, mifepristone accounts for over half of all U.S. abortions. Recently, the Biden administration expanded legal access to the pills. And in January, the FDA began allowing all pharmacies to offer mifepristone. In 2021, the agency stopped requiring in-person appointments, instead allowing doctors to prescribe the medication virtually and send it by mail.

Mifepristone works by blocking the hormone progesterone, causing the uterus lining to break down. Then, misoprostol causes the uterus to empty. Generally, the combination works up to 70 days, or ten weeks, after the first day of your last menstrual period. Medication abortion is highly effective in ending early pregnancies and works about 95-99% of the time, with a 0.4% risk of significant complications.

According to NARAL Pro-Choice America, medication abortion is safer than Tylenol. Although, this method is appealing for several reasons, including lower costs, ease of scheduling, little need for transportation, and quicker termination of pregnancy. Further, the organization argues that attacks on medication abortion are politically motivated rather than scientifically based.

naral abortion ad
NARAL created this graphic for sharing on social media. Credit: NARAL Pro-choice America

A report by Planned Parenthood states that mifepristone is also used for “evidence-based indications in (1) medical management of miscarriage, (2) cervical preparation for later 2nd-trimester abortion, and (3) management of 2nd and 3rd-trimester pregnancies when the fetus has died before birth”.

Shortly following the overturning of Roe v. Wade, abortion rights activist Bracey Sherman explained to Congress, in detail, the process constituting medication abortion. Having gotten pregnant at 19, Sherman understands the pressure of unplanned pregnancy and the social stigma around abortion. After trying to cause a miscarriage through unconventional means (and failing), Sherman found that mifepristone was a safe and reliable option.

Beyond the Lawsuit

Besides harming women’s reproductive freedom, the FDA’s loss could weaken its authority in other rulings.

“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions.”

Biden administration lawyers, CNBC article

Moreover, two current lawsuits seek to overturn state restrictions on mifepristone since they conflict with FDA regulations. If mifepristone loses the FDA’s approval, individual states will further restrict abortion access. GenBioPro, a generic pill manufacturer, filed one lawsuit in West Virginia, which has a near-total abortion ban. Conversely, a North Carolina doctor is seeking to block the state’s restrictions on the pill. Many states have conditions that go beyond FDA regulations. In Texas, for example, the drug is banned after seven weeks of pregnancy and cannot be mailed.

CVS and Walgreens are working on getting certified to dispense mifepristone after Republican attorneys general in 20 states warned them against mailing the pill. As the largest drugstore chains in the U.S., their certification would vastly increase the availability of mifepristone.

Currently, there is little legal precedent over the ability of a court to overturn FDA approval. Should that occur, though, it is likely that the Biden administration would appeal to the 5th Circuit Court in New Orleans. However, since they are generally conservative, the case could end up in the Supreme Court.

Written By

hi! i'm nic (she/they) and i am a third year english lit major at the university of san francisco! i enjoy writing about queer topics and social issues and really appreciate you reading my articles :)

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