Coalition Argues that Revoking FDA Approval of Medication Abortion Would Endanger Lives Nationwide
NEW YORK – New York Attorney General Letitia James today led a multistate coalition to defend and protect safe access to medication abortion nationwide. In an amicus brief filed in Alliance of Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), a case pending in the U.S. District Court for the Northern District of Texas, Attorney General James and the coalition of 22 attorneys general ask the court to reject a challenge brought by anti-abortion groups seeking to revoke the FDA’s approval of the medication abortion drug, mifepristone. The brief warns that withdrawing federal approval for mifepristone would drastically reduce access to safe abortion care and miscarriage management for millions of people across the country, including in New York. A ban on mifepristone would affect states where abortion is legal, like New York. Attorney General James and the coalition are urging the court to reject this baseless attempt to undermine the FDA’s authority, upend decades of medical practice, and disrupt the rule of law.
“Blocking access to this safe and effective medication is a dangerous attack on reproductive freedom and public health,” said Attorney General James. “Decades of medical and clinical research have proven that medication abortion is safe. Despite these facts and its widespread use, we know this is not a debate about science. Access to safe reproductive healthcare could be in jeopardy for millions of Americans because of a baseless lawsuit. We are taking action to protect the reproductive freedoms of people in every corner of the country, especially in vulnerable communities. Every time they try to chip away at our rights, we will rise up and fight back to protect access to safe abortion care.”
In 2000, the FDA approved mifepristone as a single-dose oral medication used for early-term abortions. Since its approval, mifepristone has been safely used by approximately five million persons to terminate a pregnancy and is used in more than half of all abortions today. Decades of clinical research and studies have confirmed mifepristone’s safety and efficacy.
If the district court orders the FDA to withdraw its approval for mifepristone, the medication would be removed from the market nationwide. In their brief, the coalition argues that requiring the FDA to withdraw its approval of mifepristone, despite the overwhelming clinical data demonstrating its safety and efficacy, risks undermining the integrity of the FDA’s approval process for other drugs.
The availability of the abortion pill has been particularly critical in providing access to abortion in low-income, underserved, and rural communities. The coalition also asserts that revoking the FDA approval of mifepristone would force millions to seek more invasive and expensive procedural abortions, which would disproportionately harm vulnerable, low-income, and underserved communities. Without access to mifepristone, demand for procedural abortions would significantly increase, leading to overburdened clinics, longer wait times, later and more risky procedures, and more complicated and costly logistics for many patients, especially those in low-income and rural communities. According to 2020 data, 89 percent of U.S. counties have no abortion clinic, and 38 percent of women of reproductive age reside in counties with no clinics. Moreover, lack of access to safe abortion care leads to worsened health outcomes and higher mortality, especially for Black women.
“At Planned Parenthood, we believe health care providers must be allowed to administer the most effective evidence-based and patient-centered health care available, and that includes providing the method of abortion care that works best for a patient’s circumstances,” said Georgana Hanson, Interim President and CEO, Planned Parenthood Empire State Acts. “Using mifepristone for medication abortion is extremely safe and effective, and has been used by more than five million people since the FDA approved it more than 20 years ago. We are extremely grateful for the leadership of New York Attorney General Letitia James and her coalition partners in working to address the nationwide threat of this case, and the potential impact it could have on the ability of people across the country to access abortion care. Attorney General James continues to show her strong commitment to combating politically motivated attacks designed to ban abortion, birth control, and other sexual and reproductive health care. Her voice is critical in the fight to ensure patients can access medication abortion with as few barriers as possible, both in New York and across the country.”
“On behalf of our members and the patients they serve, the National Abortion Federation applauds Attorney General James’ leadership in countering yet another attack on basic health care,” said Talcott Camp, Chief Legal and Strategy Officer, National Abortion Federation. “What the plaintiffs seek in this case would strike a blow to the evidence-based, patient-centered care our members provide and intensify the public health emergency SCOTUS precipitated in overturning Roe. We stand with all the attorneys general who stood up today for reproductive health, rights, and justice.”
“Access to mifepristone is and has been an essential part of women’s healthcare for decades,” said Sonia Ossorio, Executive Director, Women’s Justice NOW and NOW-NYC. “Attempts to ban FDA’s approval of this drug is an attempt to deny women the right to medication abortion across the entire country. The ruling in this case could have severe implications for women’s ability to access safe and timely abortions and that’s why attorney generals are joining Attorney General Letitia James in this critical legal fight.”
“At the miscarriage and abortion hotline we talk with New Yorkers and people from around the country who are exercising their human rights by safely managing their miscarriages and abortions with mifepristone and misoprostol,” said April Lockley, DO, Medical Director, Miscarriage and Abortion Hotline. “It’s imperative that all people have access to these safe medications in order to practice their right to bodily autonomy and reproductive freedom.”
“We believe that should an unjust ruling be made, people all over the country will understand this to be an overreach of the courts, figure out ways to continue to get the pills, and mobilize to demand access to what the whole world knows is a safe, effective, and critically needed medication,” said Linda Prine, MD, Health Care Across Borders. “For our part, we will do everything we can to continue to promote access to Mifepristone and Misoprostol.”
Joining Attorney General James in filing today’s amicus brief are the attorneys general of California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Washington, Wisconsin, and Washington D.C.
This matter is being handled by Assistant Solicitor General Daniel S. Magy, Deputy Solicitor General Ester Murdukhayeva, and Solicitor General Barbara D. Underwood — all of the Division of Appeals and Opinions, and Special Counsel for Reproductive Justice Galen Leigh Sherwin of the Executive Division, which is overseen by First Deputy Attorney General Jennifer Levy.
