Skip to main content

UPDATED: Experts Respond to Texas Mifepristone Ruling

By May 16, 2023No Comments

Less than a month ago, a federal judge in Texas issued a ruling revoking authorization for mifepristone, a safe and effective medication essential for reproductive care that was approved by the FDA more than 20 years ago. Not only did this ruling risk barring the use of mifepristone for safe and legal abortions for millions of American women, disproportionately harming low-income individuals, women of color, and those without regular access to a nearby health care provider – it also laid the groundwork for any judge to be able to overrule the evidence-based and scientific FDA medication approval process, throwing the entire system into chaos. 

The Supreme Court has stayed Judge Matthew Kacsmaryk’s ruling for now, allowing mifepristone to remain on the market for now, but the case is still in motion. The Fifth Circuit Court of Appeals is poised to rule on the merits of the case shortly. Read Protect Our Care’s statement on the SCOTUS order here.

23 states and 253 members of Congress – joined by physicians, health care experts, and legal experts – overwhelmingly agree that this case is built on unfounded legal arguments supported by anecdotes and cherry-picked studies. If Judge Matthew Kacsmaryk’s ruling stands, the consequences for patients would be disastrous. 

Fifth Circuit Appeal

Former FDA Officials 5th Circuit Amicus Brief: The Texas Ruling Threatens Patients’ Access to Critical Drugs That Prevent Suffering and Save Lives. A group of six former FDA officials, including David Kessler, Jane Henney, Margaret Hamburg, Michael A Friedman, Joshua Shafstein, Stephen Ostroff, and Norman “Ned” Sharpless, filed an amicus brief in support of the FDAt “In reviewing an administrative agency’s action based on the agency’s evaluation of scientific evidence, such as FDA drug approval decisions, courts have emphasized that they will uphold the action as long as it is within a zone of reasonableness and meets the standard of rationality required by the Administrative Procedure Act. In this case, instead of reviewing FDA’s approval of mifepristone and subsequent modifications to its conditions of use under this firmly established standard, the district court substituted its own opinions about FDA’s evaluation of the scientific data for the expert judgments of FDA clinicians and scientists, and on that basis overturned FDA’s approval of mifepristone. This unprecedented order turns Congress’s desired regulatory scheme on its head and opens the door to constant legal challenges of drug approvals. If allowed to stand, the district court’s order would threaten the incentives for drug companies to undertake the time- consuming and costly investment required to develop new drugs and provide patients access to critical remedies that prevent suffering and save lives.” [Former FDA Officials Brief, 5/2/23]

Amicus Brief By 23 States And The District Of Columbia: Overturning FDA Approval Has Devastating Consequences For The Industry And The Public. A coalition of 23 states—including New York, Arizona, California, Colorado, Connecticut, Delaware, Hawai‘i, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and Wisconsin—and the District of Columbia filed an amicus brief in support of an appeal: “In this case, allowing the district court to unilaterally substitute its judgment for the FDA’s determinations—in defiance of the scientific evidence and in a manner that unduly burdens rather than assures safe access—contravenes the mandate of the FDA and undermines the integrity of the FDA-approval process, with devastating consequences for the industry and the public. Providers and patients in amici States rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions experienced by their residents, including asthma, HIV, infertility, heart disease, diabetes, and more. […] These harmful outcomes would cause ripple effects across the entire health system. In many amici States, the same facilities providing abortion also offer other critical services, such as pre- and post-natal care, family planning, cancer screening, and other critical forms of preventative health care. Delays resulting from increased demand for abortion procedures (in lieu of medication abortions) will obstruct access to all care offered at those facilities, inevitably resulting in higher rates of unintended pregnancy and sexually transmitted infections, barriers to early detection and treatment for breast, ovarian, and testicular cancers and chronic diseases, and worsened overall health outcomes. Underserved groups, including women of color, low-income women, people with disabilities, and LGBTQ individuals, will be hardest hit. And increasingly poor overall health outcomes will impose substantial costs on amici States and local governments. By contrast, in amici States’ experience, the alleged strains on the health care system purportedly caused by the FDA’s regulatory decisions, which the district court accepted as fact, have simply never materialized.” [New York et al. Brief, 5/1/23]

Amicus Brief By 253 Members of Congress: The Texas Ruling Poses A Serious Health Risk & Would Erect Additional Barriers To Health Care. “[T]he district court’s stay of the U.S. Food and Drug Administration’s September 28, 2000 Approval of mifepristone and other challenged agency actions has no basis in law, threatens the Congressionally mandated drug approval process, and poses a serious health risk to pregnant individuals by making abortion more difficult to access […] [T]he district court’s order not only misapplies the law but also threatens to harm 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, and amici call on this Court to give due weight to that intent.  […] By curtailing access to the most common method of medication abortion, the district court’s order would erect additional barriers to health care for vulnerable populations. Reduced abortion access is also associated with higher rates of poverty, and lower educational attainment for both children and parents. The unavailability of mifepristone will have an especially acute impact on Black maternal health. In 2020, maternal death rates were 62 percent higher in abortion-restriction states than in abortion access states.” [253 Members of Congress Brief, 5/1/23]

Former DOJ Officials Amicus Brief in Alliance for Hippocratic Medicine v. FDA. “In this brief, former high-ranking officials from both major parties, who hold opposing views on the moral and jurisprudential aspects of abortion, argue the District Court wrongly assumed that the FDA has the authority under the Food, Drug & Cosmetic Act to consider unrelated laws when it reviews applications for approval of new drugs. FDA’s role is to determine the safety and efficacy of drugs based on scientific evidence and not to purport to enforce laws over which they do not have enforcement authority. Amici also demonstrate how the court’s interpretation of the Comstock Laws from 1873—federal anti-vice law that criminalizes the mailing of abortion drugs when intended for use in unlawful abortions—was wrong and its rejection of DOJ’s interpretation of those laws misplaced.” [Former DOJ Officials Brief, 4/13/23]

Motion To Stay

Amicus Brief By 240 Members of Congress: Texas Ruling Second-Guessed Scientific Determinations with Cherry-Picked Anecdotes To Upend the Status Quo. “The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo. […] the district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” write the lawmakers, adding: “The consequences of the district court’s remedy could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective. […] Its perilous consequences reach far beyond mifepristone. Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more.” [240 Members of Congress Brief, 4/11/23]

Former FDA Officials Supreme Court Amicus Brief: This Ruling Puts the Country on a Dangerous Path Towards a Piecemeal Regulatory Scheme Congress Already Rejected in 1938. “Courts lack the expertise to step into FDA’s shoes by second-guessing FDA’s experts on the safety and efficacy of drugs. Assuming that role would require in expert judges to learn how to do what FDA’s expert pharmacologists, toxicologists, chemists, epidemiologists, physicians, and data scientists have spent lifetimes training to do. Getting it wrong can lead to catastrophic consequences—measured not in dollars, but in human lives— and deprive patients of life-saving medication they depend upon. FDA’s modern authority over drug approvals evolved in response to a series of public health crises that occurred over the last century. In response to these crises, Congress steadily expanded and centralized FDA’s authority over drug approvals to give FDA more discretion to protect public health. Congress codified FDA’s accelerated approval authority in 2012, when it passed the Food and Drug Administration Safety and Innovation Act.” [Former FDA Officials SCOTUS Brief, 4/17/23]

Pharmaceutical Companies 5th Circuit Amicus Brief: Texas Ruling Will Shatter the FDA’s Gold Standard Approvals Method. ““[T]he opinion identified no errors in FDA’s scientific judgment or calculations. Instead, the court proffered its own, competing analysis, which lacked any evidence that could support the type of rigorous scientific decision-making with which FDA is tasked. The court cast aside not only the voluminous scientific evidence FDA considered at the time of approval, but also nearly a quarter century of subsequent data showing safe and effective use of the drug. In its place, the court relied on personal stories told by plaintiffs and cherry-picked, unreliable publications—many of which were not even submitted to FDA. The court then ruled that FDA was required to refuse to approve the NDA based on the court’s own non-scientific assessment of this alternative, incomplete record.” [Pharmaceutical Companies, Executives, And Investors Brief, 4/11/23]

NAACP Legal Defense Fund 5th Circuit Amicus Brief: Texas Ruling Directly Undermines the Supreme Court and the Public Interest. “Because the district court’s opinion will impact the availability of mifepristone in all 50 states, it is contrary to the minimal assurances provided for in Dobbs. Justice Kavanaugh’s concurrence emphasized that the Dobbs decision ‘does not prevent the numerous States that readily allow abortion from continuing to readily allow abortion’ and that all states ‘may evaluate the competing interests and decide how to address this consequential issue.’ Rather than leave it to individual states to ‘readily allow abortion,’ as encouraged by Justice Kavanaugh, the district court’s order disallows the two-step medication abortion option entirely. The Supreme Court opined thirty years ago that ‘[t]he ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.’ Increased abortion access has had a demonstrably positive economic impact on women, and on Black women, in particular. A review of the data from 2020 among states that report racial and ethnic data on abortion patients indicates 39 percent identify as non-Hispanic Black, and among those aged 15-44 there were 24.4 abortions per 1,000 non-Hispanic Black women. When people can decide if, when, and how many children to have, they are able to make conscious determinations about other aspects of their lives.” [NAACP Legal Defense And Educational Fund Brief 4/11/23]

American College of Obstetricians and Gynecologists 5th Circuit Amicus Brief: The District Court Relied on Biased and Flawed Studies to Justify Ruling. “Without any form of the evidentiary hearing and in complete disregard to the overwhelming body of evidence proving that mifepristone is safe, the District Court’s order (the “Order”) purports to suspend the use of treatment essential to amici’s patients, in order to further its own ideological agenda and that of Appellees. The decision is rife with medically inappropriate assumptions and terminology. It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care. It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.” [Medical and Public Health Societies Brief, 4/11/23]

Doctors for America 5th Circuit Amicus Brief: Banning the Use of Mifepristone Would Endanger the Health of Patients. “An injunction reversing the approval of mifepristone would remove the availability of an evidence-based treatment that is the safest and best option for many patients. As physicians describe… the removal of mifepristone would undermine their ability to provide safe and effective management of early pregnancy loss.” [Doctors for America Brief, 2/13/23]