All. for Hippocratic Med. v. U.S. Food & Drug Admin.
| Decision Date | 07 April 2023 |
| Docket Number | 2:22-CV-223-Z |
| Parties | ALLIANCE FOR HIPPOCRATIC MEDICINE, et al., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants. |
| Court | U.S. District Court — Northern District of Texas |
Before the Court is Plaintiffs' Motion for Preliminary Injunction (“Motion”) (ECF No. 6), filed on November 18, 2022. The Court GRANTS the Motion IN PART.
Over twenty years ago, the United States Food and Drug Administration (“FDA”) approved chemical abortion (“2000 Approval”). The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all Plaintiffs' petitions challenging the 2000 Approval date back to the year 2002, right?
Simply put, FDA stonewalled judicial review - until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.” 21 C.F.R. § 10.30(e)(2)). But FDA waited 4,971 days to adjudicate Plaintiffs' first petition and 994 days to adjudicate the second. See ECF Nos. 1-14, 1-28, 1-36, 1-44 (“2002 Petition,” “2019 Petition,” respectively). Had FDA responded to Plaintiffs' petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days.
Plaintiffs are doctors and national medical associations that provide healthcare for pregnant and post-abortive women and girls. Plaintiffs sued Defendants to challenge multiple administrative actions culminating in the 2000 Approval of the chemical abortion regimen for mifepristone. ECF No. 1 at 2. Mifepristone - also known as RU-486 or Mifeprex - is a synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death. ECF No. 7 at 7-8.[1] Because mifepristone alone will not always complete the abortion, FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother's womb. Id. at 8.
In 1996, the Population Council[2]filed a new drug application (“NDA”) with FDA for mifepristone. ECF No. 1 at 35. Shortly thereafter, FDA reset the NDA from “standard” to “priority review.” Id. In February 2000, FDA wrote a letter to the Population Council stating that “adequate information ha[d] not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.” ECF No. 1-24 at 6 (emphasis added). FDA also noted the “restrictions on distribution will need to be amended.” Id.
Mere months later, FDA approved the chemical abortion regimen under Subpart H, commonly known as “accelerated approval” and originally designed to expedite investigational HIV medications during the AIDS epidemic.[3]Subpart H accelerates approval of drugs “that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).” 21 C.F.R. § 314.500.
FDA then imposed post-approval restrictions “to assure safe use.” See 21 C.F.R. § 314.520. These restrictions were later adopted when Subpart H was codified as a Risk Evaluation and Mitigation Strategy (“REMS”) “to ensure that the benefits of the drug outweigh the risks.” 21 U.S.C. § 355-1(a)(1)-(2). The drugs were limited to women and girls with unborn children aged seven-weeks gestation or younger. ECF No. 7 at 9. FDA also required three (3) in-person office visits: the first to administer mifepristone, the second to administer misoprostol, and the third to assess any complications and ensure there were no fetal remains in the womb. Id. Additionally, abortionists were required to be properly trained to administer the regimen and to report all adverse events from the drugs. Id.
Plaintiffs American Association of Pro-Life Obstetricians & Gynecologists (“AAPLOG”) and Christian Medical & Dental Associations filed the 2002 Petition with FDA challenging the 2000 Approval. Id. In 2006, the U.S House Subcommittee on Criminal Justice, Drug Policy, and Human Resources expressed the same concerns and held a hearing to investigate FDA's handling of mifepristone and its subsequent monitoring of the drug.[4] Then-Chairman Souder remarked that mifepristone was “associated with the deaths of at least 8 women, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.”[5]Additionally, Chairman Souder noted “more than 950 adverse event cases” associated with mifepristone “out of only 575,000 prescriptions, at most.”[6] The subsequent Staff Report concluded that FDA's approval and monitoring of mifepristone was “substandard and necessitates the withdrawal of this dangerous and fatal product before more women suffer the known and anticipated consequences or fatalities.”[7]The report stated the “unusual approval” demonstrated a lower standard of care for women, “and [mifepristone's] withdrawal from the market is justified and necessary to protect the public's health.”[8]
FDA rejected the 2002 Petition on March 29, 2016 - nearly fourteen years after it was filed. ECF No. 7 at 9. That same day, FDA approved several changes to the chemical abortion drug regimen, including the removal of post-approval safety restrictions for pregnant women and girls. Id. at 10. FDA increased the maximum gestational age from seven-weeks gestation to ten-weeks gestation. Id. And FDA also: (1) changed the dosage for chemical abortion; (2) reduced the number of required in-person office visits from three to one; (3) allowed non-doctors to prescribe and administer chemical abortions; and (4) eliminated the requirement for prescribers to report non-fatal adverse events from chemical abortion. Id.
In March 2019, Plaintiffs AAPLOG and American College of Pediatricians filed the 2019 Petition challenging FDA's 2016 removal of safety restrictions. Id. On April 11, 2019, FDA approved GenBioPro, Inc.'s abbreviated new drug application (“ANDA”) for a generic version of mifepristone without requiring or reviewing new peer-reviewed science (“2019 Generic Approval”). Id. Two years later, on April 12, 2021, FDA announced it would “exercise enforcement discretion” to allow “dispensing of mifepristone through the mail . . . or through a mail-order pharmacy” during the COVID pandemic - notwithstanding the nearly 150-year-old Comstock Act banning the mailing of “[e]very article, instrument, substance, drug, medicine or thing” that produces “abortion.” Id. Finally, on December 16, 2021, FDA denied most of Plaintiff's 2019 Petition. Id. at 11. Specifically, FDA expressly rejected the 2019 Petition's request to keep the in-person dispensing requirements and announced that the agency would permanently allow chemical abortion by mail. Id.
After Plaintiffs filed suit, Danco Laboratories, LLC (“Danco”) - the holder of the NDA for mifepristone - moved to intervene as a defendant. ECF No. 19. On February 6, 2023, this Court granted Danco's motion. ECF No. 33. Plaintiffs now seek a preliminary injunction ordering Defendants to withdraw or suspend: (1) FDA's 2000 Approval and 2019 Approval of mifepristone tablets, 200 mg, thereby removing both from the list of Approved Drugs; (2) FDA's 2016 Changes and 2019 Generic Approval; and (3) FDA's April 12, 2021, Letter and December 16, 2021, Response to the 2019 Petition concerning the in-person dispensing requirement for mifepristone. ECF No. 7 at 12. Additionally, Plaintiffs seek to enjoin Defendants from taking actions inconsistent with these orders. Id.
A court may issue a preliminary injunction when a movant satisfies the following four factors: (1) a substantial likelihood of success on the merits; (2) a substantial threat of irreparable harm if the injunction does not issue; (3) the threatened injury outweighs any harm that will result if the injunction is granted; and (4) the grant of an injunction is in the public interest. See Louisiana v. Becerra, 20 F.4th 260, 262 (5th Cir. 2021). “The purpose of a preliminary injunction is always to prevent irreparable injury so as to preserve the court's ability to render a meaningful decision on the merits.” Canal Auth. of State of Fla. v. Callaway, 489 F.2d 567, 576 (5th Cir. 1974). The same standards apply “to prevent irreparable injury” under the Administrative Procedure Act (“APA”). See 5 U.S.C. § 705; Wages & White Lion Invs., L.L.C. v. U.S. Food & Drug Admin., 16 F.4th 1130, 1143 (5th Cir. 2021).
The judicial power of federal courts is limited to certain “Cases” and “Controversies.” U.S Const. art. III, § 2. The case-or-controversy requirement requires a plaintiff to establish he has standing to sue. See Cibolo Waste, Inc. v. City of San Antonio, 718 F.3d 469, 473 (5th Cir. 2013). To have standing, the party invoking federal jurisdiction must show: “(i) that he suffered an injury in fact that is concrete, particularized, and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that the injury would likely be redressed by judicial relief.” TransUnion LLC v. Ramirez, 141 S.Ct. 2190, 2203 (2021). Courts should assess whether the alleged injury to the plaintiff has a “close relationship” to harm “traditionally” recognized as providing a basis for a lawsuit in American courts. Id. at 2204. “[S...
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