Alliance for Hippocratic Medicine et al. v. United States Food and Drug Administration et al. (2:22-cv-00223)

  • Case: Alliance for Hippocratic Medicine et al. v. United States Food and Drug Administration et al.
  • Filed: 18 Nov 2022
  • Case no.: 2:22-cv-00223 (Northern District of Texas Amarillo Division)
  • View docket on CourtListener

Notable documents

  • 1-4 – Exhibit 3 – Declaration of Mario R. Dickerson (executive director of Catholic Medical Association) (12 Nov 2022)
  • 1-7 – Exhibit 6 – Declaration of Dr. Quentin Van Meter (president of American College of Pediatricians) (11 Nov 2022)
    • Van Meter argues that use of mifepristone may interfere with puberty, that there is insufficient evidence for the safety and effectiveness of mifepristone, and that minors and adults therefore cannot offer informed consent to abortion with mifepristone.

6 . I currently serve as the president of the American College of Pediatricians.

. . .

10 . I am familiar with the FDA’s approval of mifepristone and issuance of a risk evaluation and mitigation strategy (REMS) for the chemical abortion drug regimen, which includes both mifepristone and misoprostol.

11 . I understand that prior to the 2000 approval of mifepristone, the FDA never required a clinical study evaluating the safety and effectiveness of chemical abortion drugs on pregnant girls under 18 years of age.

12 . As a blocker of the hormone progesterone, mifepristone is an endocrine disruptor and, therefore, could interfere with pubertal development or adversely impact an adolescent girl’s developing body and reproductive system. The FDA’s failure to require pediatric clinical studies places girls at risk from these drugs, which have the potential to dangerously adversely impact the health, safety, and welfare of the exposed adolescents.

13 . To my knowledge, the FDA’s 2000 approval of mifepristone for use in girls was unsupported by any scientific data showing that chemical abortion drugs are safe for girls under 18 years of age.

14 . By failing to require studies, the FDA’s 2000 approval placed young girls going through their reproductive development at risk.

15 . Numerous studies have demonstrated that there is an increased risk from chemical abortion drugs to pregnant women and girls as compared to surgical abortion.

16 . One recent study discovered that one-third of all post-abortion hospital emergency department visits in 2015 were after use of chemical abortion drugs. The FDA’s elimination of REMS and loosening of restrictions increases the risk that girls will suffer complications from chemical abortion drugs.

17 . I am also aware that, in 2016, the FDA eliminated the requirement that abortionists report non-fatal adverse events—preventing the agency, women and girls, their doctors, and the public from having an accurate understanding of the complications from chemical abortion drugs and the rate at which they occur.

18 . Women, girls and their parents cannot give informed consent to chemical abortions drugs without this necessary information. And doctors cannot accurately apprise their patients about the dangers of chemical abortion drugs without adequate studies elucidating these risks.

Resources

See also

  • Alliance for Hippocratic Medicine
  • American College of Pediatricians
  • American College of Pediatricians et al. v. Becerra et al. (1:21-cv-00195)
  • Catholic Medical Association
  • Mario R. Dickerson
  • Ethics and Public Policy Center
  • Dr. Quentin L. Van Meter

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Last updated on 20 Mar 2023 by Zinnia Jones