Legal Bans on Abortion Pill Access Undermine Federal Authority

Blocks on prescription and distribution of FDA-approved mifepristone threaten pharmaceutical innovation and investment.

By Ellie Purinton

In June of 2022, the overturning of Roe v. Wade and women’s federally guaranteed right to abortion rocked the nation. Now, the abortion debate has once again risen to the forefront of the legal world through challenges over access to mifepristone, one of two drugs used to induce medical abortions. In August of 2023, a federal appeals court ruled for plaintiffs who challenged the Food and Drug Administration’s approval of mifepristone, and the ability for the medication to be mailed.

The challenge to the FDA’s approval of mifepristone threatens healthcare for all individuals. Overturning the FDA approval would not only result in harmful consequences for women and healthcare professionals, but it would also disrupt the role of the FDA and impede drug innovation. Regardless of whether one personally believes abortion is right, everyone would suffer if the courts were able to reverse the approval.

The overturning of the approval of mifepristone would have a negative impact on women, particularly those from disadvantaged communities. “If more restrictions get put back in place, it really falls disproportionately on people who are lower income and more at risk for criminalization, because these are the people who are going to have a harder time traveling or spending the money to get around restrictions,” says David Cohen, a a professor at Drexel University’s Thomas R. Kline School of Law whose work focuses on how the law impacts abortions.

In addition to this ruling harming women’s health, it would also place an unfair burden on the medical community. A 2023 survey of forty abortion providers found that most of these physicians believed that women could safely use mifepristone without a supervising healthcare provider. Additionally, most physicians in the survey felt that the evidence for the safety and efficacy of medication abortion was sufficient. Not only does the FDA has in the past found mifepristone to be safe and effective, but many physicians are comfortable enough with the drug for them to support women using it on their own. The Dobbs decision would force physicians into difficult ethically ambiguous situations, making them decide between their pledge to “do no harm,” and the legal implications of their decisions.

“The abortion-providing community is very determined and they will do whatever they can that is legally possible. And to go even further, some of them, an unknown number, will do things that are in a gray area of legality,” says Carole Joffe, a sociologist and reproductive rights advocate, and professor at the University of California, San Francisco’s Bixby Center for Global Reproductive Health. “If a woman gets the pills online, but then she is worried about whether she is bleeding too much, some of these doctors will counsel her and treat her even though that raises risk to them as well as to the patient.”

The fight to control abortion pills threatens the FDA’s autonomy

But the threat to woman’s health and the burdens this decision would place on the medical community are not the only harm that a reversal of the mifepristone approval would cause. “There are two fronts to this battle, so to speak. One of them is what is going on with self-managed abortion and the other front of the battle is the suit against the FDA and what is legally possible, and both are very important parts of the story,” says Joffe.

The FDA emerged in 1906 with the passage of the Pure Food and Drug Act. This act protected consumers from inaccurate labels and harmful products. Since it was created, the goal of the FDA has remained to make medical products safe and effective, and to help provide the public with accurate scientific information to use these products. At its core, the FDA is an institution based on science. The administration assesses clinical trials, critiques data, and weighs the benefits of introducing drugs to the public. It is partly due to the robust scientific assessments of the FDA that doctors feel comfortable prescribing critical drugs to patients, and patients feel comfortable taking these drugs.

While the FDA is rooted in data, the abortion debate is one that involves politics and theologies. In another lawsuit filed in November 2022, a group of anti-abortion physicians called the Alliance for Hippocratic Medicine sued the FDA , claiming that the FDA approval of mifepristone in 2000 was improper. The organization claimed that the approval of mifepristone was not supported by enough scientific evidence, even though the agency had paradoxically demanded more evidence for that drug than for others it has approved. The case was presented to a former anti-abortion and anti-LGBTQ activist judge on a federal court in Texas, who ruled that the FDA approval of mifepristone was improper.

The case was appealed by the FDA, and the Supreme Court is currently deciding whether to take the case. The Alliance for Hippocratic Medicine’s case primarily rests on the idea that there is not sufficient science showing the safety of the drug. However, the risk of death from mifepristone is significantly lower than many common drugs; the risk of death is ten times higher in Viagra. Clearly, the problem is not that scientific data is lacking.

If the FDA approval of Mifepristone was overturned by the courts based on politics, then this would open the door for the same thing to happen for other drugs. “The concern is that this case would open the door to challenges of other politically contentious drugs, so drugs around birth control, gender affirming care, or assisted reproduction; anything related to a politically controversial area of medicine would now be subject to attack in court,” says Cohen.

Drug company innovation is also at stake

Not only would this have the potential to keep life-saving drugs from entering the market, but it would also decrease the innovation of drug companies. Clinical trials can cost companies millions. According to a study published in the Journal of Health Economics in 2016, the average cost of developing a new drug is between $2 billion and $3 billion. If there was a chance that a company’s drug could be approved by the FDA and then simply shot down by the courts, then this risk may not be worthwhile.

This problem is especially relevant for companies that develop drugs for rare diseases. According to an analysis of clinical trials published in the Public Library of Science in 2019, many clinical trials for rare diseases are not completed due to funding and patient retention. There is already a lack of incentive for rare disease drug development without the legality of approvals being called into question; allowing courts to overturn FDA approvals could result in further setbacks towards innovation. In an amicus brief of the Texas court’s decision, the FDA wrote that manufacturers invest in costly research and clinical trials with the knowledge of the FDA’s regulations and procedures. In a world where FDA approvals could be threatened by the courts, manufacturers would be forced to navigate complicated and uncertain judicial decisions to determine what is necessary for drug approval.,

Of course, the FDA is not a flawless institution. In recent years, they have come under fire for approving drugs that later have been shown to have no significant benefits, or worse, have dangerous side effects. For example, weight-loss drug lorcaserin was approved in 2012, and removed from the market in 2020 for potential cancer risks. While the FDA does sometimes approve drugs that later display safety concerns, they rigorously assess new data to ensure the safety of drugs.

Despite its shortcomings, the FDA is still vital to drug development and public health. Efforts should be made to improve the faults of the administration, instead of dismantling its authority one drug at a time. In a world where the mifepristone approval is revoked, women’s health, the medical community, and drug development will suffer, along with every American regardless of their personal beliefs.