By Rose Tracy, JHBL Staff Member
Introduction
The clash between scientific expertise and political considerations is nothing new in the United States.[1] However, tension has risen substantially after the decision in Dobbs v. Jackson Women’s Health Organization, where the Supreme Court overturned the constitutional right to abortion.[2] While Dobbs was primarily concerned with procedural abortion, its repercussions have extended to other aspects of reproductive healthcare, including abortion medication.[3] Prior to the Dobbs decision, the Food and Drug Administration (FDA) held the authority over approval and regulation of drugs in the United States.[4] However, after Dobbs, the Fifth Circuit heard the case Alliance of Hippocratic Medicine v. FDA, where anti-abortion doctors challenged the FDA’s longstanding approval of mifepristone, the first pill of a two-pill regimen that is used for abortions and miscarriages.[5] Following the Texas federal district court’s attempt to block the FDA’s approval of the drug, the Supreme Court granted a stay on the lower court’s decision.[6] The U.S. Department of Justice subsequently filed a writ of certiorari, and the Supreme Court agreed to review the case on March 26th, 2024.[7] While the Supreme Court ultimately determined that the plaintiffs likely lacked standing, it left unanswered the question of who holds authority in determining the validity of scientific data.[8] Allowing plaintiffs to challenge the FDA’s scientific determinations, subject to judicial review, poses significant risks, particularly for low-income individuals and marginalized communities.[9]
Background
Federal agencies like the FDA serve to marshal governmental resources and have the power to improve the lives of individuals in the United States by regulating medicine and public health.[10] The FDA is required to assess whether a new drug application provides “substantial evidence” of effectiveness from “adequate and well-controlled investigations.”[11] Congress empowers the FDA to exercise its expertise to issue regulations that specify the precise criteria to enforce statutes and offer guidance to regulated industries.[12] These regulations govern clinical study standards, post-market safety evaluations, product labeling specifications, insurance coverage requirements, reimbursement, and fraud and waste management.[13] Furthermore, the FDA regularly updates regulations to ensure that programs are informed by the latest evidence-based practices.[14]
The FDA can only issue informed and responsive regulations if its expert judgment on scientific findings is not constantly subjected to second-guessing by courts.[15] Congress cannot anticipate all regulatory issues that an agency may encounter, and therefore, statutes interacting with these regulations typically contain gaps and ambiguous language.[16] Ambiguous statutes, like Texas’s restriction on access to abortion medication, give rise to challenges of scientific expertise when the policies involve special subject matters such as environmental science, medicine, and public health.[17] The Chevron deference is a legal doctrine that provides federal agencies like the FDA with authority to interpret the ambiguous language within these special subject matter policies based on the agency’s relevant subject matter expertise, administrative experience, and political accountability.[18] Undermining this authority invites legal challenges to federal agency determinations and leaves courts with the impractical task of deciding the correct interpretation of statutes without practical expertise and public engagement.[19] This threatens federal agencies’ ability to provide uniform and reliable regulation standards, undermines the public’s faith in scientific findings, and further disadvantages marginalized communities.[20]
Outcomes & Consequences
Consequently, legal challenges lead to unexpected barriers and inconsistent policies, leaving women unable to rely on current reproductive rights protections.[21] For example, the production of this blog post was put on hold until the Alliance of Hippocratic Medicine v. FDA was decided on March 26, 2024, highlighting the real-time inconsistency of reproductive rights in the United States.[22]
The unreliable nature of these legal challenges has long-term effects as well.[23] Successful challenges to federal agencies’ statutory interpretation can lead to inconsistent rulings in different jurisdictions, causing confusion and unnecessary costs for healthcare providers and stakeholders.[24] This inconsistency shifts the burden to federal agencies to defend routine practices, diverting resources from regulation to legal and compliance efforts.[25] Court interference also increases public distrust of scientific institutions and hinders public health efforts, disproportionately impacting women- particularly Black women, women of color, non-binary individuals, and the queer community.[26]
Undermining the right for women to make autonomous choices about their bodies is increasingly tied to challenges against federal agencies’ expertise. This link between bodily autonomy and the FDA’s authority to make scientific judgments jeopardizes the integrity of scientific findings, allowing personal morals and belief systems to influence regulatory and judicial decisions.[27] If the FDA’s discretion and rigorous research can be questioned by judges, physicians, and anti-choice organizations, in practice this accommodates bias and prejudices and compromises women’s health outcomes.[28]
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Rose is a second-year law student at Suffolk University Law School with an interest in gender justice, disability law, and fighting discrimination against marginalized communities. She received a bachelor’s degree in Psychology with a double concentration in Neuroscience and Clinical from the University of Rhode Island.
[1] See Chevron U.S.A. Inc. v. Natural Resources Defense Council, 468 U.S. 1227 (1984).
[2] See Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215, (2022).
[3] See Alliance of Hippocratic Medicine v. Food and Drug Administration, 78 F.4th 210 (5th Cir. 2023).
[4] See Espey, infra note 9.
[5] See id.
[6] See generally id. Granting a stay essentially puts the case on “hold.” Id.
[7] See Nationwide Threat to Medication Abortion, Ctr. for Reprod. Rts. (2024), https://reproductiverights.org/case/alliance-for-hippocratic-medicine-v-fda/ [https://perma.cc/8JCT-3DJQ]. See also Supreme Court Procedures, United States Courts (last visited April 7, 2024), https://www.uscourts.gov/about-federal-courts/educational-resources/about-educational-outreach/activity-resources/supreme-1 [https://perma.cc/9VM3-VG73]. A writ of certiorari is a court process to seek judicial review of a decision by a lower court. Id.
[8] See Espey, infra note 9. See also VanSickle infra note 22 Standing is the legal requirement that plaintiffs need to bring a legal challenge. Id. The plaintiff must show that they suffered a concrete harm. Id.
[9] See Eve Espey et al., Understanding the Impacts of the Supreme Court Case FDA v Alliance of Hippocratic Medicine, J. Am. Med. Ass’n (Mar. 25, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816816?resultClick=1 [https://perma.cc/F37Z-QFGP]. Restrictions will amplify obstacles to medication abortion for marginalized communities and compound the systemic barriers attached to their lived experiences. Id.
[10] See Daniel G. Aaron & Avery E. Emory, US Supreme Court Limits on the Power of US Health Agencies, J. Am. Med. Ass’n (Mar. 20, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816603 [https://perma.cc/HPX7-6TKZ].
[11] See id.
[12] See id.
[13] See id.
[14] See Aaron, supra note 10. The FDA issues new or revised regulations roughly every two weeks. Id.
[15] See Sahil Agrawal et al., Implications for Public Health Regulation is Chevron Deference Is Overturned, J. Am. Med. Ass’n (Mar. 20, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816604?resultClick=1 https://perma.cc/LNK4-KPF8].
[16] See id.
[17] See id.
[18] See id.; see also Chevron U.S.A. Inc. v. Natural Resources Defense Council, 468 U.S. 1227 (1984).
[19] See Agrawal, supra note 15.
[20] See id. See also Espey, supra note 9. Rollbacks will disproportionately impact low-income individuals and historically marginalized populations (e.g. based on race and ethnicity). Id.
[21] See generally Holly Fernandez Lynch & Aaron S. Kesselheim, The FDA in the Crosshairs- Science, Politics, and Abortion, J. Am. Med. Ass’n (Mar. 25, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816668?resultClick=1 [https://perma.cc/ANH5-M2PV].
[22] See Abbie VanSickle, Supreme Court Seems Inclined to Reject Bid to Curtail Abortion Pill Access, N.Y. Times (Mar. 26, 2024), https://www.nytimes.com/2024/03/26/us/politics/supreme-court-abortion-pill-hearing.html?unlocked_article_code=1.fk0.Nhdz.5sibd3phk6zD [https://perma.cc/A996-P4FB] (updating coverage periodically as oral arguments and judicial decisions progressed).
[23] See Espey, supra note 9.
[24] See Agrawal, supra note 15.
[25] See id.
[26] See id.; see also Espey, supra note 9.
[27] See Daniel G. Aaron et al., Court Intrusion Into Science and Medicine– The Mifepristone Decisions, 329 J. Am. Med. Ass’n, 1735 (2023), https://jamanetwork.com/journals/jama/article-abstract/2804473?resultClick=1 [https://perma.cc/K5RL-9PDE].
[28] See id.