Abortion drug case likely headed to Supreme Court after Republican-appointed judges agree to restrict access

A high-stakes lawsuit over the future of a widely used abortion drug is likely heading to the US Supreme Court, set to determine the fate of abortion rights access across the country for a second time within two years.

Three Republican-appointed judges on a federal appeals court have determined that the federal government did not follow proper procedures when it amended regulations for a commonly used medication abortion drug in 2016. But the restrictions will not immediately take effect.

The panel partially upheld a ruling from a Donald Trump-appointed federal judge in Texas, whose sweeping decision earlier this year threatened to strip access to the drug altogether. Nothing in the ruling from a three-judge panel on 16 August will go into effect until the nation’s highest court weighs in.

Wednesday’s ruling argues that the US Food and Drug Administration unlawfully expanded access to mifepristone, which was first approved by the federal government more than 20 years ago. The US Department of Justice will appeal the ruling.

Mifepristone was first approved by the FDA in 2000 and is approved for use up to 10 weeks of pregnancy. A vast majority of abortions occur within the first nine weeks of pregnancy. From 2019 through 2020, nearly 93 per cent of all abortions were performed before the 13th week, according to the US Centers for Disease Control and Prevention.

The medication – part of a two-drug protocol for medication abortions, the most common form of abortion care in the US – is the subject of a lawsuit from a group of anti-abortion activists represented by right-wing Christian legal group Alliance Defending Freedom, which joined efforts to overturn Roe v Wade at the Supreme Court last year.

“The FDA will finally be made to account for the damage it has caused to the health of countless women and the rule of law,” Alliance Defending Freedom senior counsel Erin Hawley said in a video statement on Wednesday. “This is a significant victory of the doctors and the medical associations we represent, and more importantly, the health and safety of women.”

In April, US District Judge Matthew Kacsmaryk – a former right-wing activist lawyer who was appointed to the federal judiciary by Mr Trump – issued a ruling to suspend the FDA’s approval, which was immediately challenged by abortion rights advocates, providers, major medical groups, drug manufacturers and President Joe Biden’s administration.

An initial ruling at the US Court of Appeals for the Fifth Circuit blocked part of that decision but struck down policies for mail-in prescriptions and rules that expanded the drug’s approval for pregnancies up to 10 weeks.

On 21 April, the Supreme Court blocked the lower courts’ rulings from taking effect while the case plays out, retaining the status quo while the legal case plays out. The latest court decision is largely identical to the preliminary issued earlier this year, but the Supreme Court’s freeze remains in effect.

Following the Supreme Court’s conservative supermajority decision to revoke a constitutional right to abortion care in Dobbs v Jackson Women’s Health Organization, at least 15 states – mostly across the US South – have effectively banned most abortions and imposed criminal penalties against providers.

Abortion rights advocates and providers have warned that eliminating or restricting access to mifepristone could drastically impact an already-fragile landscape for abortion care.

Vice President Kamala Harris warned that the lawsuit is “a threat to a woman’s freedom to make decisions about her own body and another step towards the ultimate goal of a nationwide abortion ban.”

Center for Reproductive Rights president Nancy Northup said the decision “sets up a showdown at the Supreme Court over baseless attacks on medication abortion, which has been a lifeline since the high court reversed Roe last year.”

“This order, if allowed to take effect, could jeopardize the FDA’s entire scientific system of drug approvals and would leave patients panicked and confused about their health and safety,” she added.

A ruling that undermines the FDA’s drug approval process could also open the door for other activist-driven legal battles over other drugs wrapped up in political debates, potentially inviting other destabilising lawsuits to Covid-19 vaccines, contraception, HIV medication, gender-affirming care, and other life-saving drugs.

The vice president said a decision that sides with the plaintiffs “endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”

For now, the drug remains lawfully available and on the market under the FDA’s current guidelines.

Evan Masingill, CEO of generic mifepristone manufacturer GenBioPro, said the company remains “concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the [FDA’s] regulatory authority.”

“We will continue to use our company’s legal and regulatory tools to ensure access to mifepristone, which is essential to the health of many in the United States,” he added.