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 does this ruling risk barring the use of mifepristone for safe and legal abortions for millions of American women, but it lays 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. Low-income individuals, women of color, and those without regular access to a nearby health care provider will be disproportionately harmed by these restrictions.
The Supreme Court is expected to decide on a stay on the decision this week. Watch Protect Our Care’s event with legal and public health experts discussing the dangers of Judge Kacsmaryk’s ruling here.
Health care and legal experts overwhelmingly agree that this case is built on an unfounded legal arguments and, if Judge Matthew Kacsmaryk’s ruling stands, the consequences for patients would be disastrous.
Physicians, Former FDA Officials, and Pharmaceutical Companies
American Medical Association: This Ruling Flies in the Face of Science. “Today’s court decision from a federal district court in Texas staying longstanding approval of mifepristone… threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years. Additionally, this decision introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration (FDA). Doing so goes against the established scientific process that leads to those decisions and puts other drugs at risk of being subject to similar efforts. Substituting the opinions of individual judges and courts in place of extensive, evidence-based, scientific review of efficacy and safety through well-established FDA processes is reckless and dangerous.” [American Medical Association, 4/7/23]
Letter from Over 300 Current and Former Pharmaceutical Industry Executives: This Decision Flies in the Face of Scientific and Legal Precedent. “On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry. Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” [Letter In Support of the FDA’s Authority to Regulate Medicines, accessed 4/18/23]
Statement from Jim Stansel, Executive Vice President of the Pharmaceutical Research and Manufacturers of America: The FDA is the Gold Standard for Determining Whether a Medicine is Safe and Effective. “PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making. Patients and their doctors rely on the FDA to serve as an expert and trusted arbiter of what medicines are safe for use so they can make the most informed health care decisions. Moreover, undermining the FDA’s longstanding authority given to them by Congress to approve drugs would have a chilling effect on the research and development ecosystem. Biopharmaceutical researchers and scientists need certainty that FDA approvals will be upheld so they can make the long-term investments required to develop new medicines and ultimately get them approved for use by patients. At a time when medical innovation has never been more promising, it is vital we have a legal and policy environment that fosters the development of new treatments and cures and protects patients’ access to the medicines they need.” [Phrma, 4/12/23]
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]
Former FDA Officials 5th Circuit 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.” [Brief of Former FDA Officials, 4/17/23]
Opinion of Dr. Jamie Rowen, Associate Professor of Legal Studies and Political Science, and Dr. Tami S. Rowen, Associate Professor of Obstetrics, Gynecology and Gynecologic Surgery: Ruling Heightens All the Risks Associated with Abortion. “In this case, and using the doctors’ own theory of harm, there are actually numerous benefits that the plaintiff doctors receive from having mifepristone available to pregnant people in Texas. Those who cannot access mifepristone will have to either use less effective medication regimens or will be forced to get surgical abortions at later gestational ages. Delays means the fetus continues to grow, a fact about abortion access restrictions that deeply troubled Justice Kennedy. Studies have also shown mifepristone to be helpful with labor induction, increasing the safety of the delivery process for someone who does continue with a pregnancy. Ongoing research into other applications for mifepristone may be interrupted by these judges’ decisions that limit the ways the drug can be used. [I]t is difficult to see how the FDA’s approvals of other medications are not vulnerable. For example, COVID-19 vaccines do not require an in-person doctor’s visit. Doctors who have been vocally opposed to the COVID-19 vaccine can easily find information to support arguments that they will have to care for vaccine injuries.” [PennLive, 4/17/23]
Statement from Holly Fernandez Lynch, Assistant Professor of Medical Ethics and Law: Texas Ruling is a Truly Unprecedented Decision. “What has happened in this case from the Northern District of Texas is that we have a single federal judge who has inserted himself, standing in for the agency to say FDA should have never approved mifepristone because they did not have adequate data to determine that it was safe. There was no new evidence that was presented to the court that would change FDA’s determination about whether this product meets the statutory standard for approval. What changed in this case was that ultimately the litigants were able to get their arguments in front of a federal judge.” [NPR, 4/11/23]
Statement from Khiara M. Bridge, Professor of Law: Ruling Creates Risk of Judges Reversing Other FDA Approvals. “We had accepted that federal law would preempt state law, that it would be preposterous that one federal judge in one district in Texas—or in any other state—would be able to affect the availability of a drug that had had FDA approval for 20 years. Now the things that we thought we knew about the relationship between federal law and state law, and the FDA’s ability to regulate, have been called into question. How many folks claim to have been injured by vaccines or have been injured by [being] allergic to penicillin? How many people can say they have been injured by drugs and could use those numbers as a reason to doubt the legitimacy of the approval process? We’re in really shaky territory when it comes to certainty about things that are available today.” [Wired, 4/13/23]
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]
Insider: Washington District Judge Thomas O. Rice. Contradicts Texas Ruling, Forbidding Mifepristone Bans. “[J]ust minutes after the Texas ruling was made public, Washington State Judge Thomas O. Rice issued his own ruling on mifepristone, arguing the exact opposite of Kacsmaryk, and prohibiting the FDA from pulling the drug from the market. Rice said a nationwide injunction on the pill would be ‘inappropriate.’ The Texas lawsuit was filed by the Alliance Defending Freedom, representing a coalition of medical groups and doctors who oppose abortion. The group alleged that mifepristone is dangerous and rallied against the FDA’s initial approval of it more than 20 years ago. Meanwhile, in Washington State, several Democratic attorneys general filed a lawsuit against the FDA accusing the agency of excessively regulating the pill. The judge in the case responded by prohibiting the FDA from taking ‘any action’ that would cause the drug to ‘become less available.’” [Insider, 4/7/23]
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]
Over 200 Reproductive Health, Rights, and Justice Organizations 5th Circuit Amicus Brief: The District Court effectively Substituted Itself for the Agency as the Expert Evaluator of Drug Safety. “Despite the fact that the challenged approval has been in effect for over twenty years, the court—citing nothing more than plaintiffs’ assertions in their brief—declared that medication abortion causes ‘physical and emotional trauma,’ ‘mental and monetary costs,’ and death. Rather than stay this erroneous decision in its entirety, the Fifth Circuit compounded the problem. In its 2016 approval, the FDA relied on no fewer than 12 independent clinical studies, collectively representing “well over 30,000 patients,” and conclusively showing ‘serious adverse events’ at rates ‘generally far below 1.0%.’ Hundreds of additional high-quality studies conducted since mifepristone’s 2000 approval show the same.” [Brief Of Over 200 Reproductive Health, Rights, And Justice Organizations, 4/14/23]
Statement from Nancy Northup, President and CEO of the Center for Reproductive Rights: This Ruling Is Wrong on the Facts and Law. “The appellate court order repeats serious errors in Judge Kascmaryk ruling [sic]. Again, it is wrong on the facts and the law, resulting in an unprecedented override of the FDA’s scientific judgment. The court rightly found that some claims were filed too late, but that should not distract from the radical assault on the FDA’s decision-making authority and the fact that it will wreak havoc on the provision of medication abortion if it stands.” [Center for Reproductive Rights Press Release, 4/13/23]