ICYMI: New Amicus Briefs Sound Alarm on Urgent Need to Protect Medication Abortion Access
For Immediate Release: Feb. 2, 2024
WASHINGTON, D.C. — Underscoring the unprecedented nature of a lawsuit that could wreak havoc on abortion access nationwide, scores of elected officials and organizations filed new amicus briefs in advance of the Supreme Court oral arguments in Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration. The case challenges evidence-based actions by the FDA that expanded access to mifepristone and will determine the conditions under which the medicine, which is commonly used for medication abortion, can remain on the market.
The court's decision could not only turn the clock back on access to mifepristone and further reduce access to abortion across the country — but it could also impair the regulatory authority of the oldest consumer protection agency in the U.S. federal government. Patient access to other FDA-approved drugs would hang in the balance. Nearly three dozen briefs submitted point to the outrage over a politically charged maneuver to rob people of the right to control their own bodies, including the following:
Reproductive Health, Rights, and Justice Organizations
From the brief submitted by 237 reproductive health, rights, and justice organizations — including Planned Parenthood Federation of America:
“Restrictions on mifepristone would have widespread detrimental consequences. The Fifth Circuit’s decision reimposes a burdensome in-person dispensing requirement and narrows the types of medical professionals who can become certified prescribers. As a result of these restrictions, even people in states where abortion remains legal and protected could find themselves unable to timely access mifepristone, imperiling access to abortion and jeopardizing the health and autonomy of those denied care. Clinics and providers—including several amici—could find themselves unable to effectively provide competent and much-needed medical care.
“Far from protecting patient health, the Fifth Circuit’s decision will have severe and damaging consequences unsupported by law or science. The decision should be reversed.”
From the brief submitted by the American Civil Liberties Union, Center for Reproductive Rights, and the Lawyering Project:
“The evidence upon which the lower courts relied cannot survive even passing scrutiny. While the Administrative Procedure Act authorizes judicial review of agency action in limited circumstances, the courts below committed clear error when they displaced FDA’s judgment based on junk science.”
Health Care, Pharmaceutical, and Research Groups
From the brief submitted on behalf of the American College of Obstetricians and Gynecologists, American Medical Association, and over a dozen other medical societies:
“Respondents, who represent a group of clinicians opposed to abortion, make inaccurate and disproven assertions about mifepristone’s effects and the experiences of clinicians who prescribe and patients who use the drug.
“The Fifth Circuit accepted these assertions with no evidentiary hearing, while simultaneously discounting the overwhelming evidence that mifepristone is a safe and essential component of reproductive health care…By seeking to limit access to a safe and effective drug in every state in the country, regardless of that state’s laws related to abortion and the fact that mifepristone is also used for miscarriage management and other purposes, Respondents attempt an end run around this Court’s commitment in Dobbs to leave it to the states and the elective process to address the question of abortion.”
From the brief filed on behalf of over 300 leading reproductive health researchers:
“This Court should not allow the politics of abortion to obscure the clear, abundant, and plainly sufficient scientific record supporting FDA’s decision-making in this case.
“...The studies leave no doubt as to the safety and effectiveness of mifepristone’s modified REMS and labeling. Consistent with this overwhelming evidence, this Court should reverse the Fifth Circuit’s decision.”
From the brief filed by over 300 pharmaceutical companies, executives, and investors:
“If not reversed, that decision will sharply and unnecessarily restrict the availability of a drug that has been FDA-approved for nearly a quarter-century. But that is not all. Far from being limited to a single drug, the logic of the decision below will create chaos in the processes for drug development, approval, and modification.”
Members of Congress, Governors, and State Officials:
From the largest sexual and reproductive health brief in Congressional history, filed by 263 members of Congress:
“...this Court’s reversal of the Fifth Circuit’s order with respect to FDA’s 2016 and 2021 actions is necessary to mitigate the imminent harm facing members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving drugs. Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States…”
From the the brief filed by Reproductive Freedom Alliance, a bi-partisan effort led by governors across the country:
“If the Court affirms the decision below, the upshot will be harm all around: harm to women, particularly rural and low-income women, who will be required to visit in-person clinics simply to take a prescription medication, or may not be able to access mifepristone for abortion or miscarriage management at all; harm to providers, clinics, and health systems, who will be overwhelmed with demand; harm to Governors, whose critical tools to safeguard public health will be unnecessarily curbed; and harm to the public fisc, which will bear the brunt of many of the economic costs of the decision.
“And all of this harm for what benefit? FDA has determined that the additional burdens related to in-person abortion appointments, and physician prescriptions, neither necessary nor justified…”
From the brief submitted by over 640 state legislators across the country:
“...by second guessing FDA’s actions modifying the baseline requirements for safe distribution and use of mifepristone, the Fifth Circuit has wrongly restricted state legislators’ regulatory choices, disrupting the state-level democratic processes Dobbs set in motion. This Court should overturn the Fifth Circuit’s decision enjoining FDA’s recent actions expanding mifepristone access and thereby reaffirm state legislators’ authority over abortion access issues, consistent with Dobbs.”
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Planned Parenthood is the nation’s leading provider and advocate of high-quality, affordable sexual and reproductive health care for all people, as well as the nation’s largest provider of sex education. With more than 600 health centers across the country, Planned Parenthood organizations serve all patients with care and compassion, with respect, and without judgment, striving to create equitable access to health care. Through health centers, programs in schools and communities, and online resources, Planned Parenthood is a trusted source of reliable education and information that allows people to make informed health decisions. We do all this because we care passionately about helping people lead healthier lives. Planned Parenthood Federation of America (PPFA) is a 501(c)(3) charitable organization that supports the independently incorporated Planned Parenthood affiliates operating health centers across the U.S.