Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/45

 therapeutic benefit over surgical abortion. See 21 C.F.R. § 314.500 (examples include where the benefit is the “ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy”). To the extent surgical abortion can be considered a “therapy,” the clinical trials did not compare chemical abortion with surgical abortion to find such a benefit. ECF No. 1 at 44.

Defendants argue just one “meaningful therapeutic benefit”: chemical abortion drugs avoided “an invasive surgical procedure and anesthesia in 92 percent of” patients in the trial. ECF No. 28 at 37. But “[b]y defining the ‘therapeutic benefit’ solely as the avoidance of the current standard of care’s delivery mechanism, FDA effectively guarantees that a drug will satisfy this second prong of Subpart H as long as it represents a different method of therapy.” ECF No. 1-14 at 22. And even if that were a benefit, chemical abortions are over fifty percent more likely than surgical abortion to result in an emergency room visit within thirty days. ECF No. 7 at 21. Consequently, the number of chemical abortion-related emergency room visits increased by over five hundred percent between 2002 and 2015. ECF No. 1 at 19.

One study revealed the overall incidence of adverse events is “fourfold higher” in chemical abortions when compared to surgical abortions. Women who underwent chemical abortions also experienced far higher rates of hemorrhaging, incomplete abortion, and unplanned surgical evacuation. Chemical abortion patients “reported significantly higher levels of pain, nausea,