Case: 23-10362 Document: 543-1 Page: 85 Date Filed: 08/16/2023
The FDA’s 2023 Risk Evaluation and Mitigation Strategy modification doubles down on this violation by permanently eliminating the in-person dispensing requirement. Under the 2023 REMS, pharmacies ship mifepristone to its users. To become certified to distribute mifepristone, a pharmacy must “[b]e able to ship mifepristone using a shipping service.” FDA, REMS for Mifepristone at 3 (Jan. 2023). Pharmacies must also “[t]rack and verify receipt of each shipment” and “[m]aintain records of dispensing and shipping.” Id. And distributors Danco and GenBioPro must “[s]hip mifepristone … to certified pharmacies.” Id. at 4.
All of this violates the Comstock Act by “us[ing] [an] express company or other common carrier or interactive computer service” to ship a “drug … for producing abortion.” 18 U.S.C. § 1462(c). See Alliance, 2023 WL 2913725, at *20 (“Danco has no interest in continuing to violate the law, which … it does every time it ships mifepristone.”); Alliance, 2023 WL 2825871, at *18 (“[T]he Comstock Act plainly forecloses mail-order abortion.”); Texas v. Becerra, 623 F. Supp. 3d 696, 733 (N.D. Tex. 2022) (“[F]ederal law bar[s] the importation or delivery of … medicine designed to produce an abortion.”) (citing 18 U.S.C. § 1461).
B.
The FDA asserts various atextual considerations in an effort to avoid the unambiguous meaning of the Act.
First, the FDA urges that the provisions only prohibit distribution by USPS and common carrier—and not by private carrier. But that reads the words “interactive computer service” out of the statute. The Comstock Act forbids using “any express company or other common carrier or interactive computer service” for carriage of abortifacients. 18 U.S.C. § 1462. As a practical matter, all carriers today, including private carriers, use online systems for shipping items.
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