ICYMI: Mifepristone Ruling Would Have Devastating Consequences for Abortion Access Nationwide

Ruling was contrary to a wealth of medical evidence and would severely restrict mifepristone access, derail drug development, and harm ability to bring new drugs to market, according to briefs filed in case 

Washington, D.C. – As the U.S. Supreme Court considers the Department of Justice and Danco Laboratories’ stay requests in Alliance for Hippocratic Medicine v. FDA, leading experts and advocacy groups, from PhRMA and GenBioPro to Physicians for Reproductive Health, the NAACP Legal Defense and Educational Fund, and Legal Voice, submitted amicus briefs detailing the devastating consequences if the Supreme Court lets the Fifth Circuit’s order take effect. 

Department of Justice:

The Department of Justice’s brief details that the Fifth Circuit’s ruling could have the effect of severely curtailing access to mifepristone, if not eliminating it entirely for both generic mifepristone and Mifeprex (Danco’s product), despite the court’s stated intent that Mifeprex remain available. Under this “disruptive” ruling, “All extant doses of mifepristone would immediately become misbranded, the generic version of the drug would cease to be approved, and the branded version could not be marketed until FDA and the sponsor sort through the current uncertainty and take steps to bring the drug’s labeling and other conditions into compliance with the new legal regime the lower court has abruptly imposed -- a process that FDA currently estimates could take ‘months.’ The resulting loss of access to mifepristone would be profoundly damaging.” 

Pharmaceutical Companies, Executives, and Investors:

Pharmaceutical industry representatives including BIO, Pfizer, Gilead and other companies, associations, executives, and investors highlight the importance of regulatory clarity and stability for the drug approval process and, if allowed to take effect, how the “lower court opinions will result in a seismic shift in the clinical development and drug approval processes—erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing the rigorous, well-established, and long-standing drug approval process, which is rooted in science and law.” Without relief, the impacts of the ruling “would come at the expense of patients, who would lose access to potentially lifesaving and life-improving treatments.” 

Pharmaceutical Research and Manufacturers of America (PhRMA):

As the PhRMA brief explains, by even allowing the anti-abortion groups’ lawsuit to move forward, the lower courts discarded decades of Supreme Court precedent about who can bring a case in federal court. If the Supreme Court endorses this approach to standing, it “would potentially invite limitless court challenges to FDA-approved drugs based on the mere possibility of future purported harms that are commonplace in the medical field.” This would also “threaten to create instability that could chill investment in development of medicines in the United States and slow innovation. Biopharmaceutical companies make enormous investments in drug development based on the reasonable expectation that once a drug product is approved finally by FDA under the statutory standards, barring emerging scientific data, it will be lawful and profitable to sell that product for an extended period in the United States.”

GenBioPro:

The Fifth Circuit’s decision would invalidate the approval of generic mifepristone, which is supplied by GenBioPro and effectively identical to Danco’s Mifeprex, and currently represents two-thirds of the mifepristone used domestically for medication abortions. As GenBioPro’s brief explains, this “represents a dangerous and severely disruptive departure from the norm of reasoned and science-based agency decision-making regarding drug approvals.” GenBioPro’s product is the only generic version of mifepristone on the market, and the Fifth Circuit’s ruling is “contrary to Congress’ mandate of robust generic competition and with foreseeable [effects] for both cost and access.” The brief explains that “[i]f the Fifth Circuit’s Order stands, it will pose substantial risks for the stability of federal drug regulation going forward as activists with views contrary to the great weight of mainstream scientific opinion seek out hand-selected judges to undo the decisions of the expert agency Congress appointed to oversee federal drug approval” because if GenBioPro is forced to stop production of mifepristone “the majority of the domestic mifepristone supply will disappear overnight.”

Physicians for Reproductive Health:

The brief from Physicians for Reproductive Health highlights how the Fifth Circuit’s ruling would harm patients. It notes, “while the courts below decided to substitute their judgment for that of the FDA’s and concluded that restricting the FDA approval of mifepristone is necessary to protect patients, the lower court orders will have the opposite result: they are likely to jeopardize and harm patient health… Patients should be able to select medical treatment that they determine, in consultation with their provider, is the most appropriate for their care. The Court should not interfere with that decision when the medical care in question is safe, effective, and medically appropriate.” 

NAACP Legal Defense and Education Fund:

Further, as the NAACP Legal Defense and Educational Fund’s brief explains, “the Fifth Circuit ignored the challenges many pregnant people face in accessing in-person abortion care, including increased travel times to clinics, increased wait times at those clinics, and increased costs. These challenges disproportionately harm Black and low-income pregnant people.” 

Legal Voice:

And as Legal Voice points out in its brief, “[r]estricting access to mifepristone will cause irreparable harm to the many Americans who face [intimate partner violence] and need abortions to protect their own health and safety.”

Read Planned Parenthood’s statement on the Supreme Court’s stay here.

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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.