SCOTUS ruling on mifepristone could have lasting impact on FDA regulations: experts

While experts and advocacy groups praised the U.S. Supreme Court’s Thursday decision not to limit nationwide access to the abortion pill mifepristone, they warn that access to abortion drugs remains at risk — as does the very basis of the Food and Drug Administration’s regulations for all drugs.

The court unanimously rejected a lawsuit seeking to limit nationwide access to mifepristone, one of two pills used in abortion treatment. The court ruled that a group of doctors had no standing to bring a lawsuit seeking to invalidate the FDA’s approval of mifepristone.

Although it is only recommended until the 11th week of pregnancy, the abortion pill is the cheapest form of abortion care and has become the most common form of abortion care in the U.S.

Medical abortion accounted for 63% of U.S. abortions in 2023, and its use is growing, according to a March Guttmacher Institute study. According to Guttmacher, a research and policy group advocating for reproductive health, medication abortions accounted for just 53% of all U.S. abortions in 2020.

Under Thursday’s ruling, women in states that have discontinued or limited abortion care can still access the pills by mail – a factor that had the biggest impact on the Supreme Court’s decision.

“The idea of ​​restricting access to mifepristone will further exacerbate the disparities we already see in reproductive health care,” said Dr. Reshma Ramachandran, a family physician, health services researcher and assistant professor at Yale University School of Medicine.

Women who take the abortion pill can also return to work or daily life more quickly, and patients experience fewer bleeding days and are more likely to experience major blood loss, Ramachandran said. She added that compared to a surgical abortion, the need to visit a doctor is also reduced when using abortion pills.

At least 17 states have ended almost all abortion care since the U.S. Supreme Court overturned Roe v. Wade nearly two years ago.

Impact on abortion care

Ramachandran called the Supreme Court’s decision a “relief.”

“While it’s great that they rejected it, the reasoning behind it is not so comforting because it only raises the possibility that other groups with a strong foothold could face the same challenge and could work to limit access to mifepristone,” Ramachandran said .

“I am fully aware that this continues to create additional challenges for the courts,” Ramachandran said.

The American Civil Liberties Union also warned that the ruling would not end challenges to the abortion pill.

“Even though the Court denied these specific individuals this case, anti-abortion politicians are waiting on the sidelines to continue trying to take this case to an extremist judge in Texas in an attempt to deny people access to medication abortion care,” said Jennifer Dalven, director of the ACLU Reproductive Freedom Project .

The Guttmacher Institute also warned that mifepristone plays a key role in ensuring many people can safely perform abortions themselves, saying they must remain “vigilant” as the anti-abortion movement continues to try to put care at risk across the country.

“We are relieved by this result, but we are not celebrating. From the beginning, this case was based on bad faith and had no basis in fact or science. This case should never have reached our nation’s highest court, and the Supreme Court made the only reasonable decision, leaving access to medical abortion with mifepristone intact,” Destiny Lopez, acting co-director of the Guttmacher Institute, said in a statement.

The Supreme Court has yet to rule on another case on its docket this term that could have a broader impact on life-saving emergency abortion care across the country, including in states that ban the procedure. The second case – Moyle v. U.S. – focuses on Idaho’s blanket abortion ban, which prohibits the procedure at any stage of pregnancy except to save the life of the pregnant woman or in cases of rape or incest.

The Biden administration’s lawsuit challenging the ban alleged it violated the Emergency Medical Treatment and Labor Act, a federal law that requires emergency room physicians at hospitals that receive Medicare funds to provide stabilizing health care to all patients whose health is at risk.

It’s now up to the court to determine whether the law, known as EMTALA, supersedes Idaho’s abortion ban and protects doctors’ ability to provide life-saving abortion care. The decision on this matter will have greater consequences for access to abortion across the country.

Impact on the FDA approval process

At the heart of FDA v. Alliance for Hippocratic Medicine – the case was decided Thursday – was the concern that the Supreme Court’s decision could influence decisions made by FDA experts, not only about mifepristone but potentially other drugs.

“Many of us have been watching these court cases and have been troubled by the idea that judges — without clinical or technical expertise — will be reviewing the scientific decisions that the FDA makes,” said Ramachandran, who also chairs the Doctors for America task force on FDA policy.

At least for now, the ruling keeps power in the hands of the FDA.

“Getting a drug approved is a very long process. There are many assessment teams consisting of scientists, doctors, statisticians, and basic scientists. They all play a part in analyzing the data and determining whether a drug is safe and effective for its indicated use before it reaches the market,” Ramachandran said.

“As a physician, I look to the FDA and ensure that what it approves is truly safe and effective. … It’s very much a rubber stamp,” Ramachandran said.

According to Sanket Dhruva, an assistant professor at the University of San Francisco School of Medicine who studies FDA regulation of drugs and medical devices, the FDA is then responsible for ensuring the safety of drugs once they are on the market.

Ramachandran said the FDA “went beyond regulatory standards in approving mifepristone” because of the politicization of abortion care and the expectation that the drug would be handled by many different stakeholders.

If the court ruled otherwise, there was widespread concern that it would set a dangerous precedent in which judges – who may not have the requisite expertise – would restrict patients’ access to the products, Ramachandran said.

“It would also politicize the FDA approval process for, for example, drugs used in gender-affirming care and other reproductive health care products — drugs, contraception — which is quite bizarre,” Ramachandran said.

Dhruva said that if the Supreme Court ruled otherwise, it could have “catastrophic” consequences for drug development and regulation in the US.

“You could potentially dismiss the FDA as a factor in deciding what drugs meet the safety and efficacy thresholds to be admitted to the U.S. market,” Dhruva said.

“There could be bigger problems for the drug development ecosystem because the industry may have been more reluctant to invest in the entire drug development process if there was a risk that the FDA might approve it. But then interested parties – whoever had any interest – could end up in the courts, and the courts could invalidate the FDA’s ability to approve the device,” Dhruva said.

Dhruva said that if the court found that the FDA’s authority over drug safety and suitability could be overturned, it would lead to a “significant chilling of industry investment in pharmaceutical products” and threaten the development of new drugs.

“I think it would significantly jeopardize the development of drugs for conditions that we really need,” Dhruva said.