Apr. 11, 2023), https://www.nytimes.com/2023/04/10/us/supreme-court-abortion-pill-fda.html (discussing recent rulings from the Supreme Court upholding the FDA’s authority to regulate drugs). [7] Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. 2022). [8] Defendants’ Opposition to Plaintiffs’ Motion for a Preliminary Injunction at 3, Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. Jan. 13, 2023) [“Opposition Brief”]. [9] Misoprostol has been approved by the FDA only for the prevention and treatment of gastric ulcers. Its use for abortion, miscarriage treatment or other pregnancy-related purposes is all considered “off label.” See Sarah McCammon, Why an ulcer drug could be the last option for many abortion patients, NPR, February 24, 2023, available at: https://www.npr.org/2023/02/24/1159075709/abortion-drug-mifepristone-misoprotol-texas-case [10] 21 C.F.R. §§ 314.500–314.560. [11] See 21 C.F.R. § 314.520. [12] See Opposition Brief at 3–7. [13] Plaintiffs’ Brief in Support of Their Motion for Preliminary Injunction at 25, Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022) [“Preliminary Injunction Brief”]. [14] See Complaint at 111, Alliance for Hippocratic Medicine v. US. Food & Drug Administration, No. 2:22-cv-00223-Z (N.D. Tex. Nov. 18, 2022) [“Complaint”] (“Declare that 18 US.C. § 1461 and 18 US.C. § 1462 prohibit the FDA from approving a new drug application or a supplemental new drug application that fails to limit distribution of chemical abortion drugs in accordance with these laws.”). [15] Id. at 15 [16] See 21 US.C. § 355(a), (b). [17] Preliminary Injunction Brief at 19. [18] 18 US.C. § 1641 prohibits the mailing or delivery by any letter carrier of “[e]very article or thing designed, adapted, or intended for producing abortion” and “[e]very article, instrument, substance, drug, medicine, or thing, which is advert

So, what happened? First, plaintiffs proposed a nationwide class alleging the usual – off-label promotion of a drug that (this time a heavy-duty pain reliever approved under even more restrictive marketing scheme authorized by 21 C.F.R. §314.520 (so-called “Subpart H”), because of the drug’s known risks) that they never alleged was either ineffective or injurious to any of those prescribed. Rather, “[f]or many patients, Actiq proved effective for alleviating their pain.”

Id. § 505-1(a)(2). Further, FDAAA states that drugs and biologics approved prior to the effective date of the Act are “deemed to have in effect an approved risk evaluation and mitigation strategy under section 505-1 of the [FDC Act]…if [they] are in effect on the effective date of this Act elements to assure safe use (A) required under [21 C.F.R. §§ 314.520 or 601.42]; or otherwise agreed to by the applicant and [FDA].” FDAAA § 909(b)(1).

Title IX, Subtitle A of FDAAA created new FDC Act § 505-1, which authorizes FDA to require applicants submitting a marketing application for a prescription drug or biological product to submit and implement a REMS if the Agency determines that such a mechanism is necessary to ensure that the benefits of the product outweigh its risks. Certain products approved prior to the effective date of FDAAA are, under FDAAA § 909(b)(1), deemed to have a REMS in effect “if there are in effect on the effective date of this Act elements to assure safe use -- (A) required under [FDA’s accelerated approval restricted distribution regulations at 21 C.F.R. § 314.520 or § 601.42]; or (B) otherwise agreed to by the applicant and the Secretary [of Health and Human Services] for such drug.” New FDC Act § 505-1(f)(3) states that “elements to ensure safe use” include the following:(A) health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider);(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area);(C) the drug be dispensed to patients only in certain health care settings, such as hospitals;(D) the drug be dispensed to patients with evidence or