Coverage for FDA-Approved Contraceptives: U.S. Court of Appeals for the Third Circuit amicus brief

In March 2026, CSPI’s Litigation Department took a stand for scientific integrity and public health, filing an amicus brief to challenge a Trump Administration Rule that threatens to deny tens of thousands of women access to FDA-approved contraceptives under their employer-sponsored health plans. The brief, which was filed on behalf of three former FDA officials, addresses the misleading and cherry-picked data cited by the Administration, as well as the rigorous science that goes into vetting FDA-approved contraceptives.

Contraceptive coverage mandate

Under the Affordable Care Act (“ACA”), preventative care for women must be covered by employer-sponsored health care. The Health Resources and Services Administration (“HRSA”), an agency of the Department of Health & Human Services, designates the care and contraceptives that must be covered (the “Mandate”). Since issuing its first guidelines on women’s preventative care in 2011, HRSA has required coverage for the wide array of FDA-approved contraceptives, enabling women with employer-sponsored health care to have access to birth control methods at no out-of-pocket cost. In the first few years of the Mandate, narrow exemptions were enacted for religious organizations and non-profits with faith-based objections to providing coverage for such products.

However, under the first Trump Administration, the Departments of Labor, Health & Human Services, and the Treasury (the “Departments”) jointly issued rules (“the Expanded Exemptions”) creating expanded religious and moral exemptions, allowing any employer that purports to have a religious or moral objection to providing coverage that includes contraception to opt out of the Mandate. In essence, the Expanded Exemptions make the ACA’s Mandate optional, jeopardizing access to contraception for tens of thousands of women nationwide.

Notably, as part of the attempt to justify this reduction in access, the Expanded Exemptions claim that “uncertainty” exists as to whether the FDA-approved contraceptives covered by the Mandate are safe to use and effective at preventing pregnancy – contradicting statements the Departments had made in previous, narrower versions of the religious exemption. To justify their new position, the Departments relied on flawed, often non-clinical data and cherry-picked studies that fly in the face of the rigorous standards employed by FDA when the contraceptives were approved.

The lawsuit and proceedings below

In a long-running lawsuit, the State of New Jersey and the Commonwealth of Pennsylvania (the “Plaintiff States”) challenged the Expanded Exemptions, arguing that the decision to grant such a broad exemption was arbitrary and capricious in violation of the Administrative Procedure Act. On August 13, 2025, the District Court for the Eastern District of Pennsylvania ruled in the Plaintiff States’ favor, finding, in part, that “in the face of prior, contradictory findings that contraception is safe and effective, and without evidence to refute said conclusions, the [Departments’] change-in-position ‘runs counter to the evidence.’” The Departments appealed to the United States Court of Appeals for the Third Circuit on August 20, 2025. 

The amicus brief

In March 2026, CSPI’s Litigation Department filed an amicus brief on behalf of three former FDA Officials – Dr. Margaret Hamburg, Dr. Stephen Ostroff, and CSPI’s Executive Director, Dr. Peter Lurie –in order to defend the district court’s ruling.

Specifically, the brief argued that the Departments lacked sufficient scientific basis to question the safety and efficacy of FDA-approved contraceptives, and that the scientifically rigorous FDA approval process ensures that FDA-approved contraception is safe and effective. The brief detailed FDA’s expertise in this area and the thorough vetting that contraceptive drugs and devices must go through to be approved. Further, the brief discussed the inadequacy of the studies cited in the Expanded Exemptions and why they could not support their position.