ACLU Comment on New Lawsuit Seeking to Ban Most Common Abortion Medication Nationwide

WASHINGTON — The American Civil Liberties Union (ACLU) filed a lawsuit yesterday to compel the Food and Drug Administration (FDA) to disclose records related to the agency’s review of its regulations on mifepristone, a medication used in most U.S. abortions. The lawsuit seeks to enforce the ACLU’s Freedom of Information Act (FOIA) request, filed in August, which seeks information about the scope of the review along with any communications between the FDA and anti-abortion organizations, state and federal officials, and politicians requesting greater restrictions on medication abortion. The FDA has yet to respond to the ACLU’s FOIA request or to similar requests filed by other organizations, leaving the public in the dark about steps the agency appears to be taking towards making medication abortion harder to access. “The people of this country deserve to know whether the Food and Drug Administration is following the science on medication abortion or simply following the whims of anti-abortion ,” said Rachel Reeves, staff attorney with the Reproductive Freedom Project of the American Civil Liberties Union. “We demand transparency from the Trump administration and its anti-abortion allies, because this threat to our reproductive freedom cannot continue in secrecy.” Alarming statements from Trump administration officials, including FDA Commissioner Marty Makary, have indicated that the review centers upon a deeply flawed paper, written by a Project 2025 cosponsor, that purposefully distorts the excellent safety record of medication abortion. This paper — which is not peer reviewed and is only six pages long — has been denounced by more than 260 expert researchers for its lack of transparency and gravely flawed methodology. Anti-abortion politicians are nevertheless using this paper to push for medically unnecessary restrictions, including limits on telemedicine for abortion. Today, 1 in 4 U.S. abortion patients use to safely have a medication abortion after consulting with a health care provider access to abortion will be further out of reach for patients across the nation. The FOIA request and complaint are just the latest in the ACLU’s efforts to protect and expand access to medication abortion. For instance, even as the Trump administration lays the groundwork to make mifepristone harder to access, a federal district court ruled in October in the ACLU’s longstanding case Purcell v. Kennedy that the FDA has failed to justify its current heavy restrictions on mifepristone, which already go far beyond what FDA imposes on the vast majority of medications. That recent decision prohibits the FDA from ignoring the wealth of peer-reviewed evidence on mifepristone’s safety and how the FDA’s restrictions burden patient access in conducting its new review.

The American Civil Liberties Union (ACLU) filed a lawsuit to compel the Food and Drug Administration (FDA) to disclose records related to the agency’s review of its regulations on mifepristone, a medication used in most U.S. abortions. The lawsuit seeks to enforce the ACLU’s Freedom of Information Act (FOIA) request, filed in August 2025, which seeks information about the scope of the review along with any communications between the FDA and anti-abortion organizations, state and federal officials, and politicians requesting greater restrictions on medication abortion.

HONOLULU — Today, a federal district court ruled that the Food and Drug Administration’s (FDA) imposition of medically unnecessary restrictions on the medication abortion pill mifepristone violated federal law. While this ruling does not change patients’ ability to access medication abortion in the near term, it affirms the FDA’s legal obligation to consider the overwhelming evidence of mifepristone’s safety and not to impose restrictions that unduly burden patient access to this essential medication. The court's finding that the agency failed to justify its restrictions on access to mifepristone comes as the Trump administration appears to be gearing up to make it even harder for people to get the medication nationwide. Earlier this year, the Trump administration announced that the FDA is conducting a new review of its mifepristone regulations. Secretary Kennedy has indicated that the review centers on a junk science paper, issued by a Project 2025 sponsor, that purposefully distorts the excellent safety record of medication abortion. This paper is a six-page, non-peer-reviewed document that has been denounced by more than 260 expert researchers for its lack of transparency and gravely flawed methodology. Nevertheless, in a letter to anti-abortion state attorneys general on Sept. 19, 2025, Secretary Kennedy doubled down on the publication’s importance, citing this propaganda as a “recent stud[y] raising concerns about the safety of mifepristone as currently administered.” Under today’s ruling, the FDA will need to consider the wealth of peer-reviewed evidence proving mifepristone’s safety, including when delivered by telemedicine, as well as how FDA’s restrictions burden patient access. “Today’s decision is a victory for everyone who believes that our access to safe and essential medicines should be dictated by science, not politics,” said Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project. “Despite decades of real-world experience and mountains of evidence proving mifepristone’s safety, the FDA regulates this medication more heavily than 99 percent of prescription drugs. Now, Secretary Kennedy is using more junk science to lay the groundwork for making it even harder to get a medication abortion. Today’s decision is a crucial reminder that the courts and the medical community won’t sit by while the Trump administration trashes our healthcare and our reproductive freedoms.” “I am pleased the Court recognized that the FDA’s extreme restrictions on mifepristone are not grounded in logic or science. But while this decision should be a call to action for FDA to finally lift its medically unjustified restrictions on medication abortion, I fear the Trump Administration is gearing up to make things worse,” said Heidi Purcell, M.D. “In the Hawaiian islands, where patients may live a flight away from the nearest provider, losing a telemedicine option for mifepristone would be devastating. The FDA should be working to ensure that patients in rural and underserved areas like Hawaii can access essential medications, not throwing up needless barriers to care.” “Today’s decision is a win for science, and reinforces what decades of research has shown -- there is no credible evidence to justify the current burdensome regulations on mifepristone,” said Amanda Dennis, DrPH, MBE, executive director, Society of Family Planning. “As the anti-abortion movement’s strategy of co-opting science to advance medication abortion restrictions intensifies, today’s ruling is a crucial reminder that healthcare policy must be informed by evidence, not ideology.” “As front-line physicians who provide preventive and primary care for the whole family, family physicians fight for patient access to safe and effective treatments,” said Lisa Folberg, MPP, chief executive officer of the California Academy of Family Physicians. “The FDA's needless restrictions on mifepristone make our jobs harder without any safety benefit. We appreciate that the court recognized how FDA failed to consider the toll its restrictions take on physicians trying to provide a safe and effective medication to their patients. For eight years, CAFP has been in court fighting for an FDA policy on medication abortion grounded in science, not politics or stigma. This decision is a step in the right direction.” For over a decade, medical authorities and reproductive health experts have advocated for lifting the FDA’s medically unnecessary restrictions on mifepristone. The American Civil Liberties Union first filed this case, Purcell v. Kennedy (formerly Chelius v. Becerra) on behalf of preeminent health care associations and an individual family medicine doctor in 2017. In 2021, this litigation prompted the FDA to reconsider its in-person dispensing requirement for mifepristone in light of the significant evidence that mifepristone is just as safe when dispensed through a pharmacy and that the in-person requirement severely burdened patient access. While the FDA suspended and then formally eliminated its telemedicine restrictions for mifepristone, it continued to single out mifepristone prescribers, pharmacists, and patients with medically unnecessary restrictions that severely limit patients’ ability to access medication abortion. Indeed, despite abortion opponents’ attempts to paint the FDA as inadequately restrictive, the evidence in this case showed that the FDA already regulates mifepristone more heavily than 99 percent of prescription medications. If the FDA’s mifepristone regulations are made more stringent, whether through court order or Trump administration policy changes, access to abortion will be further out of reach for patients across the nation.

McALLEN, Texas — Attorneys for Lizelle Gonzalez — a Texas woman who was unlawfully arrested and charged with murder for having a medication abortion — asked a federal court today to deny Starr County officials’ attempts to evade accountability for her wrongful arrest, prosecution, and the trauma that followed. The brief supporting Ms. Gonzalez’s opposition to the officials’ motions for summary judgement contains damning evidence of misconduct, hypocrisy, and illegality by Starr County officials. The Starr County district attorney, assistant district attorney, and sheriff pursued and then obtained an unlawful indictment against Gonzalez even though they knew that Texas law clearly prohibits the criminal prosecution of pregnant women for conduct that ends their pregnancies. Throughout this process, Starr County officials repeatedly and knowingly violated Ms. Gonzalez’s constitutional rights and attempted to hide their actions. “Lizelle Gonzalez’s highly personal decision regarding her pregnancy was not, and never has been, a criminal matter — yet the Starr County District Attorney, his assistant district attorneys, the Starr County Sheriff’s Office ignored the clear language of the Texas homicide statute and long standing law to wrongly charge her with murder,” said Cecilia Garza, partner at Garza Martinez and local counsel for Lizelle Gonzalez. “These officials abused their power and intentionally violated Ms. Gonzalez’s fundamental rights. Their wonton disregard for the rule of law and erroneous belief of their own invincibility is a frightening deviation from the offices’ purposes: to seek justice. I am proud to represent Ms. Gonzalez in her fight for justice and redemption, and our team will not allow these abuses to continue in Starr County or any other county in the state of Texas.” The civil lawsuit, brought by the American Civil Liberties Union (ACLU), the ACLU of Texas, and local firm Garza Martinez seeks to ensure that those entrusted with enforcing our criminal laws face consequences when they abuse their power and violate the constitutional rights of their community members. While the district attorney ultimately dismissed the charge against Ms. Gonzalez, her arrest on a homicide charge was highly publicized and deeply traumatizing. She spent three days in jail, away from her children, before the $500,000 bond was posted for her release. As a result of the false accusation and wrongful arrest, Lizelle Gonzalez’s life has been forever changed. Following the dismissal, the Texas bar investigated the district attorney for knowingly pursuing an unlawful indictment and made multiple findings of misconduct related to charging Ms. Gonzalez with homicide. Despite these findings, the district attorney received a minimal punishment: a small fine and a one-year fully probated suspension. Without real accountability, Starr County’s District Attorney — and any other law enforcement actor — will not be deterred from abusing their power to unlawfully target people because of their personal beliefs, rather than the law. In July 2024, the court denied Starr County officials’ attempts to have this case dismissed. The prosecutors and sheriff raised claims of legal immunity, a doctrine that they argue should insulate them from being held accountable for violating Gonzalez’s constitutional rights. Immunity doctrines create a culture in police departments and prosecutor offices where public officials may feel empowered to violate people’s rights, knowing they will face few, if any, consequences. The court denied their motions to dismiss, allowing Gonzalez’s case to proceed to the first stage of discovery concerning whether law enforcement can be held liable for violating her rights. As detailed in Gonzalez’s brief, the discovery obtained over the last year reveals a coordinated effort between the Starr County Sheriff’s Office and District Attorney’s Office to violate Ms. Gonzalez’s rights and exposes misconduct by government officials who think the law they are entrusted to enforce does not apply to them. “Lizelle Gonzalez’s life has been forever changed by the cruel and unconstitutional actions of Starr County’s elected officials,” said Lauren Johnson, director of the ACLU Abortion Criminal Defense Initiative. “Lizelle deserves justice for the trauma they have caused her and her family — and each of us deserve to be free of targeting by officials who ignore the law to unlawfully charge and arrest based on personal beliefs. We will continue fighting against the criminalization of people for the private decisions they make related to their pregnancy.” “Starr County prosecutors and law enforcement ignored Texas law when they wrongfully arrested Lizelle Gonzalez for ending her pregnancy,” said Sarah Corning, an attorney at the ACLU of Texas. “They shattered her life in South Texas, violated her rights, and abused the power they swore to uphold. Texas law is clear: a pregnant person cannot be arrested and prosecuted for getting an abortion. No one is above the law, including officials entrusted with enforcing it.”