Supreme Court is asked to weigh in on future of abortion pill
September 13, 2023 at 10:04 a.m.
WASHINGTON OSV News – The Justice Department and the manufacturer of an abortion drug asked the U.S. Supreme Court Sept. 8 to overturn a lower-court ruling that would limit access to the drug, setting the stage for the high court to weigh in on the future of the drug's availability.
A coalition of pro-life opponents of mifepristone, the first of two drugs used in a medication or chemical abortion, previously filed suit in an effort to revoke the U.S. Food and Drug Administration's approval of the drug, arguing the government violated its own safety standards when it first approved the drug in 2000.
However, proponents argued mifepristone poses statistically little risk to women using it for abortion early in pregnancy and claim the drug is being singled out for political reasons.
In its filing on behalf of the FDA, the Justice Department called the appeals court ruling an "unprecedented decision," arguing its logic "would threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment."
The filing argued the drug is safe and that "study after study" has shown "serious adverse events are exceedingly rare" when mifepristone is taken under the approved conditions. The filing added, "For many patients, mifepristone is the best method to lawfully terminate their early pregnancies."
It stated that revoking approval of the pill "would be damaging for women and health care providers around the Nation."
But in a statement, Erik Baptist, senior counsel for Alliance Defending Freedom, which is representing the pro-life coalition challenging mifepristone's approval, said the FDA "has been entrusted to serve as the nation's gatekeeper of legal drugs."
"By repeatedly and unlawfully removing critical safeguards in the chemical abortion regimen, the FDA has failed to protect the safety of women and girls," he said. "Two courts have now held the FDA accountable for the damage it has done to the rule of law and the harm it has caused to countless girls and women. We hope the Supreme Court does the same."
Earlier this year, the Supreme Court blocked a lower court's restrictions on mifepristone, leaving the abortion pill on the market while litigation proceeds. That decision froze the lower court's ruling to stay the FDA's approval of the drug.
The Justice Department and Danco, the pharmaceutical company that manufactures mifepristone, previously asked the Supreme Court to intervene in the case after an appeals court allowed portions of the ruling by U.S. District Judge Matthew Kacsmaryk to take effect.
In a Sept. 8 statement, Danco said it "continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA."
Should the Supreme Court take the case, it would likely be added to its docket in its coming term.
The two-drug chemical abortion regimen is currently legal in some form in 36 states and the District of Columbia. It is permitted in 21 states, but with some additional restrictions in the remaining 15, according to data from the Guttmacher Institute, which supports abortion access.
The Catholic Church opposes abortion, teaching that all human life is sacred from conception to natural death and that society must extend support to mothers and children. Earlier this year, Bishop Michael F. Burbidge of Arlington, chairman of the U.S. Conference of Catholic Bishops' Committee on Pro-Life Activities, denounced Biden administration's attempts to loosen regulations around the abortion bill, saying the U.S. bishops "decry the continuing push for the destruction of innocent human lives and the loosening of vital safety standards for vulnerable women."
Kate Scanlon is a national reporter for OSV News covering Washington. Follow her on X (formerly known as Twitter) @kgscanlon.
NOTES: A link to the Justice Department's filing is here: https://s3.documentcloud.org/documents/23945337/usfda-et-al-v-alliance-for-hippocratic-medicine-et-al-petition.pdf.
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WASHINGTON OSV News – The Justice Department and the manufacturer of an abortion drug asked the U.S. Supreme Court Sept. 8 to overturn a lower-court ruling that would limit access to the drug, setting the stage for the high court to weigh in on the future of the drug's availability.
A coalition of pro-life opponents of mifepristone, the first of two drugs used in a medication or chemical abortion, previously filed suit in an effort to revoke the U.S. Food and Drug Administration's approval of the drug, arguing the government violated its own safety standards when it first approved the drug in 2000.
However, proponents argued mifepristone poses statistically little risk to women using it for abortion early in pregnancy and claim the drug is being singled out for political reasons.
In its filing on behalf of the FDA, the Justice Department called the appeals court ruling an "unprecedented decision," arguing its logic "would threaten to severely disrupt the pharmaceutical industry and prevent FDA from fulfilling its statutory responsibilities according to its scientific judgment."
The filing argued the drug is safe and that "study after study" has shown "serious adverse events are exceedingly rare" when mifepristone is taken under the approved conditions. The filing added, "For many patients, mifepristone is the best method to lawfully terminate their early pregnancies."
It stated that revoking approval of the pill "would be damaging for women and health care providers around the Nation."
But in a statement, Erik Baptist, senior counsel for Alliance Defending Freedom, which is representing the pro-life coalition challenging mifepristone's approval, said the FDA "has been entrusted to serve as the nation's gatekeeper of legal drugs."
"By repeatedly and unlawfully removing critical safeguards in the chemical abortion regimen, the FDA has failed to protect the safety of women and girls," he said. "Two courts have now held the FDA accountable for the damage it has done to the rule of law and the harm it has caused to countless girls and women. We hope the Supreme Court does the same."
Earlier this year, the Supreme Court blocked a lower court's restrictions on mifepristone, leaving the abortion pill on the market while litigation proceeds. That decision froze the lower court's ruling to stay the FDA's approval of the drug.
The Justice Department and Danco, the pharmaceutical company that manufactures mifepristone, previously asked the Supreme Court to intervene in the case after an appeals court allowed portions of the ruling by U.S. District Judge Matthew Kacsmaryk to take effect.
In a Sept. 8 statement, Danco said it "continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA."
Should the Supreme Court take the case, it would likely be added to its docket in its coming term.
The two-drug chemical abortion regimen is currently legal in some form in 36 states and the District of Columbia. It is permitted in 21 states, but with some additional restrictions in the remaining 15, according to data from the Guttmacher Institute, which supports abortion access.
The Catholic Church opposes abortion, teaching that all human life is sacred from conception to natural death and that society must extend support to mothers and children. Earlier this year, Bishop Michael F. Burbidge of Arlington, chairman of the U.S. Conference of Catholic Bishops' Committee on Pro-Life Activities, denounced Biden administration's attempts to loosen regulations around the abortion bill, saying the U.S. bishops "decry the continuing push for the destruction of innocent human lives and the loosening of vital safety standards for vulnerable women."
Kate Scanlon is a national reporter for OSV News covering Washington. Follow her on X (formerly known as Twitter) @kgscanlon.
NOTES: A link to the Justice Department's filing is here: https://s3.documentcloud.org/documents/23945337/usfda-et-al-v-alliance-for-hippocratic-medicine-et-al-petition.pdf.