Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/1

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Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 1 of 67 PageID 4423

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
AMARILLO DIVISION

ALLIANCE FOR HIPPOCRATIC
MEDICINE, et al.,

Plaintiffs,

v.

U.S. FOOD AND DRUG
ADMINISTRATION, et al.,

Defendants.
2:22-CV-223-Z

MEMORANDUM OPINION AND ORDER

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.

Background

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.