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Recent rulings on mifepristone, ACA threaten public health

The United States is in poor health. Life expectancy rates have dropped precipitously, and racial health disparities continue, with white adults living more than five and a half years longer than Black adults on average. Child and teen mortality rates have also climbed, particularly among youth of color. Our maternal mortality rate is three times higher than those of other developed countries and is especially elevated for Black women.

As people who work in public health, we are alarmed by these trends and have joined our colleagues in promoting tools that can help reverse the backsliding — namely, interventions based on research and evidence.

But now some courts seem intent on disrupting access to those critical services.

On March 30, a U.S. district court in the Northern District of Texas issued a ruling limiting the scope of the Affordable Care Act’s requirements for coverage of preventive services. If upheld on appeal, this decision would mean that insurers would no longer be required to cover certain vital preventive measures, including screenings for colon, lung, and skin cancer; statins that prevent cardiovascular disease; and pre-exposure prophylaxis (PrEP) medication that provides effective prevention from contracting HIV. If insurers drop these protections, there will be profound consequences for our efforts to prevent disease, save lives, and extend the lifespans of Americans.

Days after that decision, another federal judge in the Northern District of Texas invalidated the Food and Drug Administration’s approval of mifepristone, which has been part of a two-drug regimen typically used for medication abortions and miscarriage management for more than 20 years. This decision aims to deny access to mifepristone nationwide, even in states with protections for abortion rights.

This is the first time a court invalidated the FDA’s approval of a medication over the objections of the agency. The Department of Justice has noted that neither the plaintiffs in this case nor the trial and appeals courts identified any other court decision that had abrogated the FDA’s approval of a drug on the basis of a disagreement with the FDA’s determinations of a drug’s safety or effectiveness.

This troubling judicial decision in Texas sets up a dangerous precedent for court interference in the FDA’s science-based decisions and could lead to future challenges to the availability of other prescription drugs that have already gone through the FDA’s rigorous testing and approval process. That’s why the ALS Association, American Diabetes Association, National Multiple Sclerosis Society, and more than 25 other patient groups said that “the implications of this ruling go far beyond mifepristone” and could lead judges to “block access to FDA-approved drugs and treatments for reasons having nothing to do with their safety or efficacy.” In the case of mifepristone, the FDA’s decisions were supported by numerous rigorous studies that established the drug’s safety and effectiveness over decades of use in both the U.S. and worldwide.

The overall impact of these two rulings is uncertain. For preventive care, while some insurance providers have indicated they will still cover certain treatments, that is no longer guaranteed.

As for mifepristone, on April 12, a federal appeals court blocked part of the trial judge’s ruling, allowing the drug to be procured in person, but no longer available by mail. Notably, the appeals court further restricted mifepristone by rejecting the carefully considered steps the FDA has taken over the past seven years to expand access, such as extending the window of time for the drug to be used, from seven weeks of pregnancy to 10 weeks.

Last week, in response to an emergency motion by the FDA, the U.S. Supreme Court granted a temporary administrative stay of the trial judge’s ruling. On Wednesday, the court delayed a decision on whether the Texas ruling would be stayed while the litigation continues; doing so would allow mifepristone to remain available. It has now postponed this decision to Friday, and there is intense speculation as to what the court will do, and what the next steps in the litigation may be.

While much remains in flux, what we do know for certain is that limits on preventive care and restrictions on reproductive care will harm Americans. Providing a full range of reproductive health services, including abortion, safeguards mothers and children and supports the health and financial security of families and communities. Research has shown that women who are denied abortions have higher levels of debt and experience more bankruptcies, evictions, and other financial hardships. These women are also more likely to endure physical violence from the man involved in the pregnancy.

Of the people who sought abortion care before the U.S. Supreme Court’s Dobbs decision in 2022, three-quarters were at or below the poverty level or living on low incomes, and approximately 60% were Black, Indigenous, and other people of color. Removing access to mifepristone — by narrowing or revoking the FDA’s approval — hurts these communities the most, as they have fewer resources to seek alternative options or travel to states that permit abortions.

This judicial overreach has even wider implications. If a drug’s fate is based not on science but on decisions by judges who are not medical experts, then it will have a chilling effect on pharmaceutical innovation in everything from Alzheimer’s to ALS to diabetes to cancer. More than 500 pharmaceutical executives signed an open letter after the FDA ruling, stating: “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.”

Similarly, the reduction of ACA requirements is especially harmful, not just for preventive care, but for efforts to reduce racial health disparities in accessing preventive care services. The ACA and its service requirements to provide Americans health care access were found to have reduced these disparities in routine screenings for cancer and heart disease.

It is reckless for courts to make decisions that disregard decades of clinical evidence on drug safety and effectiveness. And it is wrong for them to override the highly specialized expertise, methodologies, and mandates of public health agencies and expert groups. These court actions will result in the dismantling of public health protections. The consequences of these and other such decisions will be measured in diminished health and lost lives.

Ellen J. MacKenzie, Ph.D., Sc.M., is dean of the Johns Hopkins Bloomberg School of Public Health. Joanne Rosen, J.D., M.A., is a senior lecturer at the Johns Hopkins Bloomberg School of Public Health and co-director of the Center for Law and the Public’s Health.

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