More than 400 executives at pharmaceutical and biotech companies have signed onto a statement criticizing a ruling by a federal judge in Texas that suspends the U.S. Food and Drug Administration’s approval of a medication abortion pill.
In a letter reported by The New York Times on April 10, the senior executives of the companies condemned the U.S. District Judge Matthew Kacsmaryk’s April 7 ruling, which has yet to go into effect.
“The decision ignores decades of scientific evidence and legal precedent,” the letter stated. It argued the ruling also "set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”
In his ruling issued on Good Friday, Kacsmaryk said he would suspend the FDA's approval of the drug mifepristone, the first of two drugs used in a medication, or chemical, abortion. A coalition of pro-life opponents sought to have FDA approval of the drug revoked, arguing the government violated its own safety standard in approving the drug more than two decades ago.
Kacsmaryk's ruling came with a seven-day pause, which he said would allow the federal government to appeal and seek emergency relief. The ruling was immediately followed by an opposing ruling of another federal judge in Washington state in a separate case. U.S. District Judge Thomas Rice blocked the FDA from “altering the status quo” on the drug and stated the FDA must keep medication abortion drugs available.
Kacsmaryk’s ruling marked the most significant abortion-related court ruling since the Supreme Court issued its Dobbs v. Jackson Women’s Health Organization decision last year, which overturned prior rulings by the high court that found abortion access a constitutional right.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in his April 7 ruling. “But here, FDA acquiesced on its legitimate safety concerns -- in violation of its statutory duty -- based on plainly unsound reasoning and studies that did not support its conclusions.”
The pharmaceutical executives said their industry relies on the FDA’s autonomy in order to have a “reliable regulatory process for drug evaluation and approval.”
“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 Catholic Church teaches that all human life is sacred and must be respected from conception to natural death and, as such, opposes direct abortion as an act of violence that takes the life of the unborn child. In the wake of the Dobbs ruling, the U.S. bishops have reiterated the church's commitment to serving both women and unborn children.
A New York Times analysis of 100 studies of abortion pill usage found that while serious side effects and complications are rare for women who use the drug, with more than 99% of patients experiencing no serious side effects, those complications can include necessary medical treatment after an incomplete abortion, an infection requiring hospitalization or death.
The ruling was condemned by pro-abortion politicians but was praised by pro-lifers.
In an April 7 statement, President Joe Biden said his administration "will fight this ruling."
"The Department of Justice has already filed an appeal and will seek an immediate stay of the decision," Biden said. "But let’s be clear -- the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade."
In a statement, former Vice President Mike Pence, founder of the group Advancing American Freedom, said that Kacsmaryk’s ruling "fixed a 20 year wrong," and said his organization "will always fight for the sanctity of life and defend the unborn and women in crisis pregnancies.”
