ACLU Comment on FDA’s Updated Restrictions for Mifepristone
January 3, 2023 7:45 pm
WASHINGTON — Today, the U.S. Food and Drug Administration (FDA) released an Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, which increases pharmacy access to this safe and effective medication used for early abortion and miscarriage care but still retains medically unnecessary restrictions that impede patient access. The FDA’s decision comes at a crisis moment for reproductive freedom, as access to abortion has plummeted nationwide in the wake of the U.S. Supreme Court’s decision overruling Roe v. Wade.
Today’s release builds on the FDA’s December 2021 announcement that it would permanently repeal its outdated and medically unnecessary requirement that mifepristone be dispensed to patients only in person at a hospital, clinic, or medical office, and reflects the final culmination of agency deliberations. The FDA will now permit not only mail-order but also brick-and-mortar pharmacies to dispense mifepristone — a major step forward for patient access. However, the agency added an unnecessary pharmacy certification requirement that it does not impose for other, equally or less safe, medications. Unfortunately, the updated REMS also retains longstanding requirements that health care professionals be specially certified in order to prescribe mifepristone and that patients sign a special form in order to receive their prescription. The REMS changes are effective immediately, but may take some time to implement.
Leading medical groups — including the (ACOG), the (AMA), and the (AAFP) — have long called on the FDA to eliminate the REMS for mifepristone altogether because these restrictions have no basis in medicine and only create barriers to time-sensitive care.
In response to the FDA’s updated restrictions, Julia Kaye, staff attorney with the American Civil Liberties Union’s Reproductive Freedom Project, issued the following statement:
“We are happy the FDA has increased pharmacy access to this safe and effective medication, relieving one of the agency’s needless burdens on mifepristone patients. But leading medical groups have long called for outright elimination of the FDA’s special restrictions on mifepristone, which obstruct abortion and miscarriage patients from accessing the time-sensitive health care they need without a corresponding safety benefit. As abortion access evaporates across the country, and communities of color and people with fewer resources disproportionately suffer the severe medical consequences of forced pregnancy, the FDA’s actions — while inching toward progress — fall short of what science and justice demand.”
The FDA’s determination to permit mail-order pharmacy access for mifepristone came in response to two cases filed by the American Civil Liberties Union on behalf of leading medical associations, physicians, and reproductive justice advocates. ACOG v. FDA, filed in May 2020, sought to suspend the FDA’s in-person pill pick-up requirement for mifepristone during the COVID-19 Public Health Emergency (PHE), noting that mifepristone was the only medication out of 20,000 FDA-approved drugs that patients were required to pick up in a clinical setting but free to self-administer at home. That lawsuit prompted the FDA in April 2021 to temporarily lift the in-person requirement for mifepristone for the remainder of the PHE, consistent with the federal government’s broad suspension of other in-person requirements during the COVID-19 pandemic in the name of science and safety. Chelius v. Becerra, filed in October 2017, sought to eliminate the FDA’s entire package of medically unnecessary REMS restrictions for mifepristone, prompting the FDA to undertake a broad review of its regulations on mifepristone. The plaintiffs in the Chelius lawsuit are evaluating next steps for that litigation in light of today’s FDA’s announcement.
For 22 years, mifepristone has offered an exceedingly safe and effective, FDA-approved means of ending a pregnancy; more recently, has also confirmed its important role in helping to treat miscarriage. The agency’s unique for mifepristone provides no safety benefit, blocks access to essential health care, and disproportionately harms people who already face severe health disparities and barriers to accessing health care — including people of color, people struggling to make ends meet, and people living in rural areas.
Learn More About the Issues in This Press Release
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Press ReleaseDec 2024
Reproductive Freedom
Planned Parenthood Files Lawsuit to Restore Abortion Access, on Heels of Voters Approving Right to Reproductive Freedom InitiativePlanned Parenthood Files Lawsuit to Restore Abortion Access, on Heels of Voters Approving Right to Reproductive Freedom Initiative
KANSAS CITY — Following the passage of Amendment 3, the Right to Reproductive Freedom Initiative, Missouri’s two Planned Parenthood providers filed suit to restore abortion access in the state. The lawsuit seeks to enjoin Missouri’s numerous abortion bans and countless burdensome, medically unnecessary restrictions on abortion that do not improve care or protect patient health. Missouri will be the first state with a post-Dobbs total abortion ban to approve and implement a state constitutional amendment making abortion a fundamental right. The lawsuit was filed by Comprehensive Health of Planned Parenthood Great Plains and Planned Parenthood Great Rivers, represented by Planned Parenthood Federation of America, the ACLU of Missouri, and the American Civil Liberties Union. In the lawsuit, reproductive health care providers seek to block a number of state laws that are now in conflict with the Missouri Constitution. The lawsuit, which was filed in the 16th Circuit Court of Jackson County, requests a preliminary injunction blocking the enforcement of some of the restrictions while the case proceeds, including: Multiple outright abortion bans, including: The first total abortion ban triggered by the Dobbs decision Cascading gestational age bans Bans that stigmatize and limit abortion care based on a patient’s reason for having an abortion TRAP laws that unfairly target abortion providers, including: Unnecessary facility requirements Hospital admitting privileges requirements Biased and medically inaccurate counseling requirements Forced delay periods that require patients to make multiple trips to a clinic for care A ban on the delivery of medication abortion by telemedicine A physician-only law that prevents qualified medical professionals from providing abortion care Criminal penalties for abortion providers If the requested preliminary relief is granted, Planned Parenthood’s health centers would be able to begin providing abortion in Missouri once more — restoring access to this constitutionally protected health care. "Missourians have spoken and we're ready to deliver," said Emily Wales, president and CEO of Comprehensive Health of Planned Parenthood Great Plains. "There are many restrictions to challenge before access can be fully realized, but we're proud to continue this fight to make sure everyone in this state can have the safe, legal abortion care they deserve. And soon, when Missourians ask where they can get care, we’ll have a simple answer: right here at home." “Missourians have voted to build meaningful abortion access in their state, and our lawsuit is the next step toward that goal. Our patients and their access to the care they need have long been our north star; we see how abortion bans, TRAP laws, and political attacks have blocked them from care for far too long, said Richard Muniz, interim President and CEO of Planned Parenthood Great Rivers. “Our organization was the last abortion provider in the state before the Dobbs decision, which then forced patients to take on the additional burden of traveling out of Missouri to see our providers in Illinois — where abortion is legal, safe, and free of excessive barriers. Our patients deserve every right to control their bodies, lives, and futures — and soon, they won’t have to cross state lines to do so. We are ready to provide safe, legal abortion in Missouri again.” “With this lawsuit, we are continuing the work of rebuilding abortion access in Missouri,” said Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America. “Missourians have lived under layers of abortion restrictions for decades, including abortion bans that disproportionately endangered Black and Latino people in the state. Now is the time to peel those layers back and ensure that Missourians can make reproductive health decisions without politicians getting in the way. Planned Parenthood Federation of America is proud to fight alongside our affiliates in restoring abortion access, and we will continue to push for reproductive freedom for all Missourians.” The case, Comprehensive Health of Planned Parenthood Great Plains and Planned Parenthood Great Rivers v. State of Missouri, was brought within 24 hours of Missouri voters passing the Right to Reproductive Freedom Initiative, which appeared as Amendment 3 on the 2024 General Election ballot. The amendment creates and protects the fundamental right to reproductive freedom, which is the right to make and carry out decisions about all matters relating to reproductive health care, including prenatal care, childbirth, postpartum care, birth control, abortion care, miscarriage care, and respectful birthing conditions. “Yesterday, Missourians voted to end Missouri’s abortion ban and protect reproductive freedom. Today’s lawsuit is the next step to fulfill the promise of the amendment,” said Tori Schafer, Director of Policy and Campaigns at the ACLU of Missouri. “This is a testament to all of the people who joined our grassroots coalition of organizations and volunteers, who tirelessly collected signatures, phone banked, and knocked on doors to give Missourians the opportunity to pass Amendment 3 at the ballot box.” Following the United States Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade, Missouri became the first state to enforce a total abortion ban, with no exceptions for rape, incest, or the woman’s health. However, a web of medically unnecessary restrictions, like a mandated 72-hour waiting period, invasive and unnecessary pelvic exams, and hospital-like facility requirements, had severely limited access to abortion in the state even before the Dobbs decision. For years Missouri had only three health centers in the state providing abortion care until unnecessary restrictions became too cumbersome, leaving just one health center at Planned Parenthood Great Rivers in St. Louis to provide abortion care from 2018 until the Dobbs decision triggered Missouri’s abortion ban. Read the full petition. -
MissouriDec 2024
Reproductive Freedom
Comprehensive Health of Planned Parenthood Great Plains & Planned Parenthood Great Rivers v. MissouriComprehensive Health of Planned Parenthood Great Plains & Planned Parenthood Great Rivers v. Missouri
The ACLU, ACLU of Missouri, and Planned Parenthood Federation of America are representing Missouri’s two Planned Parenthood providers. Following the passage of Amendment 3, the Right to Reproductive Freedom Initiative, Comprehensive Health of Planned Parenthood Great Plains and Planned Parenthood Great Rivers, filed suit to restore abortion access in the state. The suit seeks to enjoin Missouri’s numerous abortion bans and countless burdensome, medically unnecessary restrictions on abortion that do not improve care or protect patient health. If the requested preliminary relief is granted, Planned Parenthood’s health centers would be able to begin providing abortion in Missouri once more — restoring access to this constitutionally protected health care. -
Press ReleaseDec 2024
Reproductive Freedom
Federal Appeals Court Affirms Decision Blocking Enforcement of Idaho Attorney General’s Prohibition on Out-Of-State Abortion ReferralsFederal Appeals Court Affirms Decision Blocking Enforcement of Idaho Attorney General’s Prohibition on Out-Of-State Abortion Referrals
BOISE, Idaho — Yesterday, the U.S. Court of Appeals for the Ninth Circuit affirmed a federal district court decision blocking enforcement of a 2023 legal opinion, issued by Idaho Attorney General Raúl Labrador, that claimed Idaho’s abortion ban prohibits health care providers from referring patients for abortions out of state. The lower court’s preliminary injunction, issued in August 2023, protects health care providers so they can continue to offer comprehensive counseling and assistance to their patients without fear of being penalized by the attorney general for providing information about health care that is legal in other states. The Ninth Circuit also held that the health care providers were likely to succeed on their claim that the attorney general’s interpretation of the state’s abortion ban violates their First Amendment rights to communicate with their patients about abortion. In states like Idaho with total abortion bans, referrals are a critical tool for providers to help patients access a full range of essential care, and a lifeline for patients who need abortion care. This is particularly true in Idaho, where the attorney general has fought to limit emergency care for pregnant patients facing complications and where OB-GYNs are fleeing the state because of fears of being penalized. Joint statement from Planned Parenthood Great Northwest, Hawai’i, Alaska, Indiana, Kentucky; Planned Parenthood Federation of America; ACLU of Idaho; and ACLU: “With this ruling, the Ninth Circuit affirmed what we have said all along: that Attorney General Labrador’s opinion poses a clear threat to Idahoans’ health, their lives, and their freedom. Preventing health care providers from serving as trusted resources for patients would endanger Idahoans and recklessly encroach on their rights. Providers shouldn’t face the threat of punishment for helping their patients obtain the abortion care they need in states where abortion is legal. “While we are relieved that this decision keeps this harmful interpretation enjoined, we know these egregious efforts to limit Idahoans’ freedom won’t stop here. We will continue to fight for every Idahoan’s freedom to make reproductive health decisions, without unqualified politicians interfering with their care.” The Ninth Circuit’s opinion comes after the Idaho attorney general appealed an August 2023 federal district court ruling which said that his interpretation of Idaho’s ban infringes on health care providers’ First Amendment right to refer their patients for abortion care. Health care providers’ inability to provide crucial medical information while the motion was pending put Idahoans in need of this vital information at risk. Under the terms of the preliminary injunction, Idaho’s attorney general cannot sanction or prosecute health care providers for referring, counseling about, or otherwise offering information to patients who seek abortion outside of Idaho’s borders. This lawsuit, Planned Parenthood Great Northwest, Hawai’i, Alaska, Indiana, Kentucky v. Labrador, was filed by attorneys from Planned Parenthood Federation of America, the ACLU, the ACLU of Idaho, and the law firms Wilmer Cutler Pickering Hale and Dorr LLP, Bartlett & French LLP, and Stris & Maher LLP on behalf of PPGNHAIK, Dr. Caitlin Gustafson, and Dr. Darin L. Weyhrich. The complaint and brief in support of their request for immediate relief are available to view. Attorneys also filed declarations from PPGNHAIK CEO Rebecca Gibron, Dr. Gustafson, and Dr. Weyhrich. -
Press ReleaseDec 2024
Reproductive Freedom
Arizona Health Care Providers File Lawsuit Challenging Abortion Ban and Resume Providing Care Across the StateArizona Health Care Providers File Lawsuit Challenging Abortion Ban and Resume Providing Care Across the State
PHOENIX — Arizona health care providers filed a lawsuit today challenging a ban on abortion after 15 weeks of pregnancy, which is in violation of the state’s new constitutional amendment protecting the fundamental right to abortion. Arizona Attorney General Kris Mayes and providers have signed a stipulation stating that the ban is unconstitutional and that the state will not enforce the ban until 30 days after final resolution of the litigation, which has allowed doctors across the state to begin providing abortion care after 15 weeks of pregnancy once again beginning today. The case, filed in Maricopa County Superior Court, asserts that the ban is unconstitutional because it denies Arizonans access to abortion care in violation of the new constitutional amendment passed by the voters. Last month, voters overwhelmingly approved Proposition 139, the Arizona Abortion Access Act, putting the power to decide whether to end a pregnancy back in the hands of Arizonans. Following the vote, the amendment was certified and officially added to the state constitution on November 25. The case was brought by Dr. Eric M. Reuss, M.D., M.P.H., Dr. Paul A. Isaacson, M.D., and Planned Parenthood Arizona, Inc., represented by the American Civil Liberties Union, the ACLU of Arizona, Planned Parenthood Federation of America, the Center for Reproductive Rights, and Perkins Coie LLP. Statement from Dr. Eric M. Reuss, M.D., M.P.H., obstetrician and gynecologist, Scottsdale Obstetrics & Gynecology, P.C.: “I am proud to participate in this lawsuit, which will mark the first step in following through with Arizona voters’ desires when they adopted new constitutional language protecting the right to abortion. For two years, physicians’ hands have been tied when a patient needs to end a pregnancy after 15 weeks, including when they face serious pregnancy complications. But today we can once again provide care to people who want to end their pregnancy. We hope the courts will quickly recognize the harms of Arizona’s ban and strike it down once and for all. This is a great day for my patients. I am thrilled to see their freedom to make their own healthcare decisions without state interference restored.” Statement from Dr. Paul Isaacson, M.D., obstetrician and gynecologist, Family Planning Associates Medical Group “As a physician, I see firsthand the devastating impact restrictive abortion laws have on my patients and their families. I joined this lawsuit because I believe that health care decisions should be made in the exam room—between a patient and their doctor—not dictated by political agendas. The constitutional amendment voters approved last month made it clear that Arizonans value the right to access safe, compassionate care, including abortion. Yet, the 15-week ban forces us to withhold essential care from patients, even when their health or future is at risk. My patients deserve better. I am hopeful that the courts will honor the will of the people and restore their right to make deeply personal decisions about their own bodies.” Statement from Dr. Jill Gibson, chief medical officer, Planned Parenthood of Arizona: “Arizonans resoundingly voted to enshrine abortion access in the state constitution when they voted YES on Prop 139 and made it clear they do not support bans on abortion. As a doctor, I know first-hand how abortion bans and restrictions force people to carry forced pregnancies, seek to self-manage their abortion when they would have preferred to access care within the health care system, or bear the financial burden of traveling hundreds or thousands of miles for care. Abortion bans not only negatively impact individual lives, they impact families and generations, and perpetuate other systems of oppression. Our community deserves the right to make our own decisions about our bodies and our health. And Planned Parenthood Arizona will not stop fighting for our patients and our health care staff.” Statement from Rebecca Chan, staff attorney, ACLU Reproductive Freedom Project: “Arizona voters sent a clear message that pregnant people should have the right to make their own personal decisions about abortion and to control their bodies and their lives. But this ban denies people that fundamental right. We have gone to court to ask the court to strike down the law to vindicate the will of the people and ensure that people can get the care they need in their own community. We applaud Arizona abortion providers for their strength in navigating this unjust law for two years and continuing to provide as much care as they were permitted to provide. We are relieved that patients who are more than 15 weeks pregnant can once again get the care they need. This case is the first step towards fulfilling the amendment’s promise.” Statement from Lauren Beall, staff attorney, ACLU of Arizona: "For decades Arizona lawmakers chipped away at the rights of people who can become pregnant and tied the hands of their healthcare providers. Voters made it clear that they’ve had enough. Today, we are asking the court to end Arizona’s dangerous 15-week ban and to affirm the will of the people. We are proud to stand by our state’s resilient abortion providers and partners to ensure everyone gets the care they need and deserve." Statement from Alexis McGill Johnson, president and CEO, Planned Parenthood Federation of America: “With their vote on Proposition 139, Arizonans said definitively that the only people qualified to make pregnancy decisions are patients and their health care providers, not politicians. It’s time for the state’s abortion law to reflect that belief and the values enshrined by the Arizona Abortion Access Act. Today, we ask the court to end Arizona’s abortion ban so that patients can get vital health care in their communities. In the coming months, Planned Parenthood Federation of America and our partners will continue to fight for Arizonans’ access to abortion, without government interference.” Statement from Nancy Northup, president and CEO, Center for Reproductive Rights: “Voters made it clear on November 5 that, when it comes to abortion rights, Arizona is not a battleground state. Arizonans voted overwhelmingly to enshrine abortion rights in the state constitution. We are going to court to challenge the state’s 15-week abortion ban and ensure that these constitutional rights are vindicated. The health and lives of pregnant Arizonans and their health providers’ ability to provide critical health care depend on it.”