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Battles Over Medication Abortion Threaten the Integrity of Drug Approvals in the U.S.

Published online by Cambridge University Press:  01 September 2023

Liam Bendicksen
Affiliation:
PORTAL, BRIGHAM AND WOMEN’S HOSPITAL, BOSTON, MA, USA
Aaron S. Kesselheim
Affiliation:
PORTAL, BRIGHAM AND WOMEN’S HOSPITAL, BOSTON, MA, USA HARVARD MEDICAL SCHOOL, BOSTON, MA, USA

Abstract

Legal challenges to the FDA’s approval of mifepristone have destabilized patients’ ability to access controversial medicines like medication abortion. We argue that federal courts’ receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.

Type
Columns: Health Policy Portal
Copyright
© 2023 The Author(s)

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Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at akesselheim@bwh.harvard.edu.

References

Alliance for Hippocratic Medicine v. US Food and Drug Administration, 2:22-CV-223-Z [ND Tex 2023].Google Scholar
Zettler, P. J. et al., “Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation,” New England Journal of Medicine 388, no. 10 (2023): e29.CrossRefGoogle Scholar
US Food and Drug Administration v. Alliance for Hippocratic Medicine, No. 22A901 [S Ct 2023].Google Scholar
See Zettler et al., supra note 2.Google Scholar
Alliance for Hippocratic Medicine v US Food and Drug Administration, No. 23-10362 [5th Cir 2023].Google Scholar
S. Novack, “‘You Know What? I’m Not Doing This Anymore,’” Slate, March 21, 2023, available at <https://slate.com/news-and-politics/2023/03/texas-abortion-law-doctors-nurses-care-supreme-court.html> (last visited June 20, 2023).+(last+visited+June+20,+2023).>Google Scholar
“Medication Abortion and the Stakes of the Lawsuit That Could Block Access to Mifepristone Nationwide,” NARAL Pro Choice America, February 10, 2023, available at <https://www.prochoiceamerica.org/wp-content/uploads/2023/02/New-NARAL-Research_-Medication-Abortion-and-the-Lawsuit-That-Could-Block-Access-to-Mifepristone-Nationwide-Final-Copy-.pdf> (last visited June 20, 2023).+(last+visited+June+20,+2023).>Google Scholar
Taylor, J. K., “Structural Racism and Maternal Health Among Black Women,” Journal of Law, Medicine & Ethics 48, no. 3 (2020): 506517.Google ScholarPubMed
Braidwood Management Inc. v. Becerra, 4:20-CV-00283-O [ND Tex 2022].Google Scholar
GenBioPro, Inc. v. Sorsaia, 2:23-CV-0058 [SD W Va 2023].Google Scholar
Zettler, P. J. et al., “Mifepristone, Preemption, and Public Health Federalism,” Journal of Law and the Biosciences 9, no. 2 (2022): 132.CrossRefGoogle ScholarPubMed
Zogenix, Inc. v. Patrick, 1:14-CV-11689-RWZ [D Mass 2014].Google Scholar
State of Washington v. US Food and Drug Administration, 1:23-CV-03026-TOR [ED Wash 2023].Google Scholar
Bagley, N. and Bray, S., “Judges Shouldn’t Have the Power to Halt Laws Nationwide,” Atlantic, October 31, 2018, available at <https://www.theatlantic.com/ideas/archive/2018/10/end-nationwide-injunctions/574471/> (last visited June 20, 2023).+(last+visited+June+20,+2023).>Google Scholar