In an open letter published in the US, pharmaceutical and biotech company executives have described as “judicial activism” last week’s ruling by a Texas judge that the US Food and Drug Administration (FDA) had erred by approving the popular abortion pill mifepristone.
Mifepristone, with misoprostol, is used in 60% of abortions within the first 10 weeks of pregnancy, reports Health Policy Watch.
It has also become the only abortion method for women living in states such as Alabama, Mississippi and Texas, where abortions are outlawed, but women are able to purchase the drugs online from other states.
The FDA, US Department of Justice and the drug manufacturer Danco Laboratories, opposed the ruling on Friday, 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: the court asked the groups opposed to mifepristone’s approval to respond to the government by midnight Tuesday.
Meanwhile, shortly after the Texas ruling, Judge Thomas Rice ruled in the Washington federal court that the FDA must ensure that mifepristone is available in 17 states and the District of Columbia.
If there is disagreement at the appeal court, the matter will go to the US Supreme Court – dominated by anti-abortion judges.
Texas judge Matthew Kacsmaryk ruled in favour of an application brought by the Alliance Defending Freedom (ADF) and others that the FDA had “improperly approved” mifepristone. ADF is the faith-based litigator group that succeeded in getting the pro-abortion Roe v Wade ruling overturned.
Kacsmaryk is renowned for his conservative views, and while working for the conservative Christian legal organisation First Liberty Institute between 2014 and 2019, had 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 the 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 wrote.
Meanwhile, US Health Secretary Xavier Becerra called the decision “reckless”, saying the Biden administration would fight to ensure women had access to the medication.
“Mifepristone is one of the safest and most effective medicines we have seen over the past 20 years to help women with their healthcare, especially abortion care,” Becerra said.
Several states such as Washington, California, Connecticut and Massachusetts, have started stockpiling mifepristone pills to ensure access if the Texas decision stands.
Should the ruling stand, women in states where abortion is still legal will have to undergo medical abortions that are riskier and costlier.
See more from MedicalBrief archives:
US AGs weigh in on court battle over access to abortion medicines
Roe vs Wade: US abortion rights’ ruling could hurt women worldwide
Canada’s benign experience with normally prescribed abortion pill mifepristone
Last Missouri abortion clinic to close