Hundreds of executives from US pharmaceutical and biotech companies have condemned as “judicial activism” last Friday’s ruling by a US District judge in Texas that the Food and Drug Administration (FDA) had erred by approving the abortion pill, mifepristone.

The FDA, US Department of Justice and the drug manufacturer, Danco Laboratories have opposed the ruling, which will now be heard by the US Court of Appeals for the Fifth Circuit.

In court papers filed on Monday, the US government and Danco asked the appeal court for a decision by Thursday and the court has asked the groups opposed to mifepristone’s approval to respond to the government by midnight Tuesday.

Meanwhile, on April 7, just hours after the Texas ruling, another US District Court Judge Thomas Rice, ruled in the state of Washington that the FDA must ensure that mifepristone is available in 17 states and the District of Columbia, which had immediately sued to preserve access to the drug. 

If there is disagreement at the US Appeals Court, where the contradictory rulings are now headed, the matter will go to the US Supreme Court, which is dominated by anti-abortion judges.

Texas judge Matthew Kacsmaryk’s original ruling banning the drug was based on a legal claim brought by a number of anti-abortion groups led by the Alliance Defending Freedom (ADF); the groups claimed that the FDA had “improperly approved” mifepristone more than two decades ago. ADF is also the faith-based litigator group that also succeeded in the appeal to the US Surpeme Court to overturn the 1973 Roe v Wade ruling on 24 June 2022 – a ruling that upended 50 years of US abortion rights protection at the federal level.  

The Trump-appointed Kacsmaryk is renowned for his conservative views. While working for the conservative Christian legal organisation, First Liberty Institute, between 2014 and 2019, he also argued against a Washington law mandating pharmacies to provide contraceptives.

“Justice Kacsmaryk’s act of judicial interference has set a precedent for diminishing the FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry,” according to the biopharma executives in an open letter published on Monday.

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they add. 

Mifepristone has been FDA-approved as safe and effective for decades.

A Texas federal court decision that attempts to override this approval threatens the rights of women nationwide to make decisions about their health care and access medication prescribed by their doctors. pic.twitter.com/nDS2CKO5J3

— Vice President Kamala Harris (@VP) April 8, 2023

Meanwhile, US Health Secretary Xavier Becerra told PBS that the decision was “reckless”, and that the Biden administration  would fight to ensure that women had access to the medication.

“We intend to do everything to make sure it’s available to them not just in a week, but moving forward, period, because mifepristone is one of the safest and most effective medicines that we have seen over the last 20 years to help women with their health care, especially abortion care,” Becerra said.

“If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?” he added.

Mifepristone, together with misoprostol, is used in 60% of abortions within the first 10 weeks of pregnancy.

It has also become the only abortion method for women living in US states such as Alabama, Mississippi and Texas, where abortions are outlawed but women are able to purchase the drugs online from other states.

Several states such as Washington, California, Connecticut and Massachusetts have started stockpiling mifepristone pills to ensure access if the Texas decision stands, according to Stat News.

Should the ruling stand, women in states where abortion is still legal will have to undergo medical abortions that are riskier and more costly.

Image Credits: Gayatri Malhotra/ Unsplash.