A decision from a federal court judge in Texas to strip long-standing government approval for a commonly used abortion drug has alarmed abortion rights groups and providers, who are bracing and preparing for whatever could come next.
On 7 April, US District Judge Matthew Kacsmaryk, who has a history of right-wing activism, sided with anti-abortion activists in a legal challenge against the US Food and Drug Administration’s approval of mifepristone, which the agency first approved for use in 2000.
The nation’s leading abortion rights advocacy groups have roundly condemned the ruling – which uses language from anti-abortion activists and dismisses findings from major health organisations that determined the drug is both overwhelmingly safe and effective – as the case makes its way to a federal court of appeals and, possibly, the US Supreme Court.
The ruling is set to take effect on 14 April unless an appeals court intervenes. The drug remains accessible in the meantime.
“It’s hard to speculate in a world where all law and fact are thrown to the wind,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a briefing with reporters on 10 April.
The US Department of Justice has appealed the decision, which government attorneys said has “upended decades” of federal guidance and risks “depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety” and efficacy.
Attorneys also are seeking guidance after a duelling federal court decision – issued just 20 minutes after the Texas ruling – told federal agencies to preserve the status quo for FDA approvals.
Jennifer Dalven, director of the ACLU’s Reproductive Freedom Project, told reporters on 10 April that there is likely to be “significant confusion and chaos as providers try to provide the best possible care they can for their patients” if the Texas ruling is allowed to stand and access to the medication is thrown into jeopardy.
Critics blast Texas ruling for ‘inflammatory’ anti-abortion rhetoric
The judge “flat-out ignored” evidence and science and instead deferred to anti-abortion activists and arguments from abortion opponents that have been “debunked in courts around the country,” according to Ms Dalven.
“It’s no accident this case ended up before a judge that was willing to go wherever the [anti-abortion activists] had led him,” she said. Anti-abortion plaintiffs incorporated in a small district of Amarillo, Texas, all but guaranteeing their case would be heard by Judge Kacsmaryk.
In his ruling, delivered on Good Friday, Judge Kacsmaryk used language pulled directly from anti-abortion activists, including referring to abortion providers as “abortionists”, abortion patients as “post-abortive women,” and a fetus as an “unborn human”.
His ruling also appeared to accuse President Joe Biden’s administration of promoting eugenics.
“The opinion really parrots the vernacular of anti-abortion activists,” according to Jenny Ma, senior staff attorney for the Center for Reproductive Rights. “That is not what a court order should look like. It is now what an impartial judge should say.”
Such “inflammatory” rhetoric signals to an “extremist right-wing anti-choice movement,” according to Mini Timmaraju, president of NARAL Pro Choice America, who called the decision an “example of minority rule at its worst.”
Following the Supreme Court’s decision to overturn Roe v Wade and revoke a constitutional right to abortion care last summer, anti-abortion activists and right-wing legal campaigns took aim at mifepristone, which is used for more than half of all abortions in the US.
The same legal group that backed the effort to overturn Roe is leading the charge against mifepristone.
Erin Hawley, senior counsel of Alliance Defending Freedom and the wife of anti-abortion US Senator Josh Hawley, criticised the FDA and a “mail-order abortion regime” following the Justice Department’s notice of appeal.
“The FDA put women in harm’s way, and the agency should be held accountable for its reckless actions,” she said in a statement through the organisation.
Stripping away access to the drug could further erode access to abortion care across the country, even in states where it is legally protected. Its potential removal could be particularly acute in more than a dozen states that have effectively criminalised care or severely restricted access in the months after Roe was overturned.
Mifepristone was approved for use by the FDA in most cases up to 10 weeks of pregnancy in 2000. A vast majority of abortions occur within the first nine weeks. From 2019 through 2020, nearly 93 per cent of all abortions were performed before the 13th week.
Mifepristone is also used to treat miscarriages. Roughly 10 per cent of clinically recognized pregnancies end in miscarriages, according to the American College of Obstetricians and Gynecologists.
Health officials and drugmakers warn of impacts beyond abortion care
A ruling to overturn the drug’s government approval is a “reckless” decision that endangers the lives of abortion patients, the public health system and democracy itself, according to Alexis McGill Johnson, president of Planned Parenthood.
The decision not only threatens access to abortion care but also could set a precedent to “radically alter” the process for approving drugs and bringing potentially life-saving drugs to market, opening the door for fringe activist groups to find ideologically aligned judges to deliver favourable rulings, according to Ms Dalven with the ACLU.
That could include federal court challenges to birth control, emergency contraception, or any drug that has drawn political opposition, including vaccines.
White House press secretary Karine Jean-Pierre told reporters on 10 April that the Texas decision is an “attack” on the FDA’s authority that “could open the floodgates for other medications to be targeted and denied to people who need them.”
A group of more than 400 executives with major drug manufacturers sounded a similar warning in a scathing letter denouncing Judge Kacsmaryk’s decision.
“The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders at Pfizer and Biogen, among others.
“If courts can overturn drug approvals without regard for science or evidence,” the letter said, “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.”
The ruling “has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” according to the letter.
Dr Jack Resnick, president of the American Medical Association, warned that the Texas ruling presents an “extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions” made by the FDA.
“Substituting the opinions of individual judges and courts in place of extensive, evidence-based, scientific review of efficacy and safety through well-established FDA processes is reckless and dangerous,” he said in a statement.
While some members of Congress have argued that the Biden administration should just ignore the ruling, other Democratic lawmakers and leading abortion rights advocates have instead urged the courts to swiftly overturn the decision.
Ignoring the ruling won’t address the drug’s future legal issues or other challenges to longstanding FDA approvals, according to Ms Dalven.
“In order to protect access to abortion and miscarriage care … the courts need to do their job and reverse this unprecedented and unprincipled decision,” she said.
