Case: 23-10362 Document: 543-1 Page: 33 Date Filed: 08/16/2023
scriber is less likely to accurately determine gestational age:
Mifepristone and misoprostol are dangerous drugs that can potentially harm women. Relaxing the required medical supervision and oversight for patients taking these drugs puts women’s health at risk.
By eliminating the in-person dispensing requirement and the requirement for a post-abortion follow-up, the FDA has exposed women to a higher likelihood of undetected serious complications. Specifically, the expanded use of telemedicine for chemical abortions means that some women who are beyond 70 days’ gestation because they are mistaken or wrong about the gestational age of their unborn child will take these drugs outside of the appropriate window.
Dr. Barrows Declaration ¶¶ 16–17; see also Dr. Skop Declaration ¶ 28 (“Unsupervised chemical abortion … harms women because they may have underestimated the gestational age of their unborn child.”). And the Doctors say that the need for in-person supervision is even greater in cases of ectopic pregnancy. Dr. Skop Declaration ¶¶ 27, 29.
Finally, many doctors offered testimony that, as a result of the 2021 Non-Enforcement Decision, more women will suffer serious adverse events. Dr. Wozniak Declaration ¶ 14 (“The increasing number of chemical abortions through mail-order or telemedicine methods means that more women will suffer complications from unsupervised use of mifepristone and misoprostol.”); Dr. Frost-Clark Declaration ¶ 12 (“The FDA’s suspension of the in-person dispensing requirement of mifepristone and misoprostol harms women and doctors because it has resulted in an increase in complications.”); see also Dr. Skop Declaration ¶¶ 20–21; Dr. Johnson Declaration ¶ 18; Dr. Jester Declaration ¶ 13. One doctor personally witnessed an increase in complications after a district court temporarily enjoined the in-person dispensing requirement in the midst of the COVID-19 pandemic. Dr.
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