Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023)/Opinion of Judge Ho
James C. Ho, Circuit Judge, concurring in part and dissenting in part:
The Constitution vests “the authority to regulate abortion” in “the people and their elected representatives.” Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228, 2279 (2022). Congress has enacted a number of laws that affect the regulation of abortion, including the Administrative Procedure Act and the Comstock Act. Those laws dictate the outcome in this case.
Congress has conferred significant regulatory power on administrative agencies such as the FDA. In exchange, Congress has enacted the APA to ensure that agency action is subject to meaningful judicial review. It requires courts to “hold unlawful and set aside agency action” that we determine to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A).
That’s precisely what occurred here. Plaintiffs challenge the FDA’s approval of mifepristone in 2000, as well as its 2016 and 2021 revisions to its mifepristone regulations. I agree with the panel majority that the FDA’s 2016 and 2021 revisions to its mifepristone regulations must be set aside as arbitrary and capricious under the APA. I would add that the FDA’s initial approval of mifepristone in 2000 also violates the agency’s own rules and thus must be set aside under the APA as well.
The FDA approved mifepristone under its Subpart H regulations. But Subpart H only authorizes the FDA to approve drugs that “treat[] serious or life-threatening illnesses.” 21 C.F.R. § 314.500. And pregnancy is plainly not an illness. So it was unlawful for the FDA to approve mifepristone under Subpart H. To quote the Population Council, the entity that sought FDA approval of mifepristone in 2000: “Neither pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.” Population Council Letter to FDA at 1–2 (Sep. 6, 2000).
Perhaps the FDA could have approved mifepristone through some other regulatory process. But established precedent requires us to review the FDA’s action based on the path it took—not the path it might have taken. See SEC v. Chenery Corp., 318 U.S. 80, 95 (1943); DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1909 (2020) (“An agency must defend its actions based on the reasons it gave when it acted.”).
The FDA’s 2021 revisions also violate the Comstock Act. That Act makes it a federal crime to mail any “article or thing designed … or intended for producing abortion,” as well as any “drug, medicine, or thing … advertised … in a manner calculated to lead another to use … it for producing abortion.” 18 U.S.C. § 1461. It also makes it a crime to “use[] … [an] express company” to ship a “drug, medicine, article, or thing designed … or intended for producing abortion.” 18 U.S.C. § 1462.
So I would affirm the district court. Accordingly, I concur in part and dissent in part.
I.
I agree with the thorough and well-reasoned panel majority opinion that Plaintiffs have demonstrated Article III standing to challenge both the FDA’s 2000 approval of mifepristone and the 2016 and 2021 revisions. I write separately to elaborate on the historical pedigree of Plaintiffs’ conscience injury, and to explore how Plaintiffs suffer aesthetic injury as well.
A.
The Supreme Court has instructed that we look to “history and tradition” as “a meaningful guide to the types of cases that Article III empowers federal courts to consider.” United States v. Texas, 143 S. Ct. 1964, 1970 (2023) (quoting Sprint Communications Co. v. APCC Services, Inc., 554 U.S. 269, 274 (2008)). We ask whether the “injury to the plaintiff has a ‘close relationship’ to a harm ‘traditionally’ recognized as providing a basis for a lawsuit in American courts.” TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2204 (2021) (quoting Spokeo, Inc. v. Robins, 578 U.S. 330, 341 (2016)).
By the standards of history and tradition, the harm to conscience that Plaintiffs suffer is a paradigmatically cognizable injury. American law has recognized conscience rights from the start. See, e.g., N.H. Const. of 1784, pt. I, art. IV (“Among the natural rights, some are in their very nature unalienable, because no equivalent can be given or received for them. Of this kind are the rights of conscience.”); Pa. Const. of 1790, art. IX, § 3 (“[N]o human authority can, in any case whatever, control or interfere with the rights of conscience.”); Ky. Const. of 1792, art. XII, § 3 (same); Ohio Const. of 1803, art. VIII, § 3 (same); Ala. Const. of 1819, art. I, § 4 (“No human authority ought, in any case whatever, to control or interfere with the rights of conscience.”); Tenn. Const. of 1835, art. I, § 3 (“[N]o human authority can, in any case whatever, control or interfere with the rights of conscience.”); Mo. Const. of 1820, art. XIII, § 4 (“[N]o human authority can control or interfere with the rights of conscience.”); Ark. Const. of 1836, art. II, § 3 (“[N]o human authority can, in any case whatever, interfere with the rights of conscience.”); Wis. Const. of 1848, art. I, § 18 (“Nor shall any control of, or interference with the rights of conscience be permitted.”); Minn. Const. of 1858, art. I, § 16 (same); Kan. Const. of 1859, Bill of Rights, § 7 (same).
Throughout the nineteenth century, American courts granted relief to parties who challenged government action as injurious to conscience. See, e.g., White v. McBride, 7 Ky. (4 Bibb) 61, 61 (1815) (suit brought against sheriff by plaintiffs who “entertained conscientious scruples against bearing arms”); In re Dorsey, 7 Port. 293, 345, 365–69 (Ala. 1838) (attorney seeking conscience-based exemption from anti-dueling oath required for bar admission); State ex rel. Weiss v. Dist. Bd. of Sch. Dist. No. 8 of City of Edgerton, 44 N.W. 967, 967–68, 976 (Wis. 1890) (writ of mandamus requested by public school students who raised conscience-based objection to curriculum).
And even where parties were not ultimately granted relief, courts entertained their suits alleging injuries to conscience and reached the merits of their claims. See, e.g., Donahoe v. Richards, 38 Me. 379, 413 (1854) (public school student raised conscience-based objection to curriculum); Innis v. Bolton, 17 P. 264, 269 (Idaho 1888) (plaintiff brought conscience-based objection to anti-polygamy oath required for voting).
Here, Plaintiffs have alleged conscience injuries analogous to those historically recognized at law and in equity. The FDA’s approval of mifepristone creates a substantial risk that Plaintiffs will be forced to participate in the abortion process. See, e.g., Dr. Francis Declaration ¶ 14 (“[M]ore physicians with ethical and medical objections to abortion will be forced to participate in completing unfinished elective chemical abortions, just as my partner was.”); Dr. Skop Declaration ¶ 34 (“The FDA’s expansion of chemical abortion … harms my conscience rights because it could force me to have to surgically finish an incomplete elective chemical abortion. I object to abortion because it ends a human life.”).
The Supreme Court has recognized that intangible interests in free speech and free exercise are sufficiently concrete for Article III standing. See Spokeo, 578 U.S. at 340. So it’s not surprising that both the FDA and intervenor Danco agree that conscience injuries can satisfy Article III. I agree with the panel majority that Plaintiffs have established Article III standing based on injury to conscience.
B.
In addition to the injuries analyzed by the majority, Plaintiffs have demonstrated another basis for Article III standing: the aesthetic injury they experience in the course of their work. See, e.g., Sierra Club v. Morton, 405 U.S. 727, 734–35 (1972) (recognizing aesthetic harm as “injury to a cognizable interest”); Lujan v. Defs. of Wildlife, 504 U.S. 555, 562–63 (1992) (“[T]he desire to use or observe an animal species, even for purely esthetic purposes, is undeniably a cognizable interest for purpose of standing.”); id. at 566 (“[T]he person who observes or works with a particular animal threatened by a federal decision is facing perceptible harm.”).
It’s well established that, if a plaintiff has “concrete plans” to visit an animal’s habitat and view that animal, that plaintiff suffers aesthetic injury when an agency has approved a project that threatens the animal. See Lujan, 504 U.S. at 564. See also Humane Soc’y v. Hodel, 840 F.2d 45, 52 (D.C. Cir. 1988) (standing where agency expanded approval for hunting, “depleting the supply of animals … that … [plaintiffs] seek to view” and causing plaintiffs to witness “animal corpses”); Am. Bottom Conservancy v. Army Corps of Engineers, 650 F.3d 652, 657 (7th Cir. 2011) (standing for birdwatchers to challenge agency permit that would allow development and thus “diminish the wildlife population visible to them”); Ctr. for Biological Diversity v. EPA, 861 F.3d 174, 183 (D.C. Cir. 2017) (standing where agency authorization to use pesticide created “demonstrable risk” to beetles and butterflies that plaintiffs intended to view).
Unborn babies are a source of profound joy for those who view them. Expectant parents eagerly share ultrasound photos with loved ones. Friends and family cheer at the sight of an unborn child. Doctors delight in working with their unborn patients—and experience an aesthetic injury when they are aborted.
Plaintiffs’ declarations illustrate that they experience aesthetic injury from the destruction of unborn life. Dr. Francis testified to working with an unborn child who was subsequently killed by mifepristone:
[A] partner of mine and I cared for another patient who also suffered complications from chemical abortion. I had taken care of her when she was hospitalized … at 9 weeks 5 days gestation. She was discharged home in good condition after significant improvement with medications. During that hospital stay, she had an ultrasound, which showed a healthy pregnancy with no apparent complications and a strong fetal heart rate. … Approximately one week after her discharge, the patient presented back at our emergency room with heavy vaginal bleeding and unstable vital signs as a result of taking chemical abortion drugs.
Dr. Francis Declaration ¶ 13.
Dr. Jester put Plaintiffs’ interest in unborn life this way: “When my patients have chemical abortions, I lose the opportunity … to care for the woman and child through pregnancy and bring about a successful delivery of new life.” Dr. Jester Declaration ¶ 19. See Ctr. for Biological Diversity v. EPA, 937 F.3d 533, 541 (5th Cir. 2019) (recognizing judicially cognizable injury where plaintiff experiences aesthetic harm at work).
The Supreme Court has recognized that “the person who observes or works with a particular animal threatened by a federal decision is facing perceptible harm, since the very subject of his interest will no longer exist.” Lujan, 504 U.S. at 566. Every circuit, including our own, has concluded that, when a federal agency authorizes third parties to harm flora or fauna that a plaintiff intends to view or study, that satisfies all of the requirements for Article III standing. See, e.g., Housatonic River Initiative v. EPA, _ F.4th _, 2023 WL 4730222, *9 (1st Cir. July 25, 2023); NRDC v. FAA, 564 F.3d 549, 555 (2nd Cir. 2009); Sierra Club v. EPA, 972 F.3d 290, 298–99 (3rd Cir. 2020); Sierra Club v. Dep’t of the Interior, 899 F.3d 260, 282–85 (4th Cir. 2018); Gulf Restoration Network v. Salazar, 683 F.3d 158, 166–68 (5th Cir. 2012); Meister v. Dep’t of Agriculture, 623 F.3d 363, 369–70 (6th Cir. 2010); Am. Bottom Conservancy, 650 F.3d at 656–60; Sierra Club v. Army Corps of Engineers, 645 F.3d 978, 985–86 (8th Cir. 2011); Cottonwood Env’t Law Ctr. v. Forest Service, 789 F.3d 1075, 1079–83 (9th Cir. 2015); WildEarth Guardians v. EPA, 759 F.3d 1196, 1206–07 (10th Cir. 2014); Black Warrior Riverkeeper, Inc. v. Army Corps of Engineers, 781 F.3d 1271, 1280–83 (11th Cir. 2015); Ctr. for Biological Diversity v. EPA, 56 F.4th 55, 66–69 (D.C. Cir. 2022).
In all of these cases, a federal agency approved some action—such as developing land or using pesticides—that threatens to destroy the animal or plant life that plaintiffs wish to enjoy. This injury is redressable by a court order holding unlawful and setting aside the agency approval.
And so too here. The FDA has approved the use of a drug that threatens to destroy the unborn children in whom Plaintiffs have an interest. And this injury is likewise redressable by a court order holding unlawful and setting aside approval of that abortifacient drug.
I see no basis for allowing Article III standing based on aesthetic injury when it comes to animals and plants—but not unborn human life.
II.
I now turn specifically to Plaintiffs’ challenge to the FDA’s 2000 approval of mifepristone. The FDA contends that the challenge is untimely. But it concedes that “the well-established reopening doctrine” is binding precedent in this circuit. Texas v. Biden, 20 F.4th 928, 951 (5th Cir. 2021), rev’d on other grounds, 142 S. Ct. 2528 (2022). And it accepts that, under that doctrine, the clock for an APA claim restarts when an agency revises its regulations in a manner that “significantly alters the stakes of judicial review.” Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008). See also NRDC v. EPA, 571 F.3d 1245, 1266 (D.C. Cir. 2009) (same).
That standard is easily met here. It seems obvious that the 2016 and 2021 revisions significantly altered the regulatory landscape. Indeed, the FDA recently told the Supreme Court that setting aside those revisions would “upend the regulatory regime for mifepristone” and “unleash[] regulatory chaos.” Application to Stay the Order Entered by the United States District Court for the Northern District of Texas and for An Administrative Stay, 2023 WL 3127519, at *2–3, FDA v. Alliance for Hippocratic Medicine, 143 S. Ct. 1075 (2023). If switching from the 2016/2021 regime to the 2000-era regime significantly alters the “basic regulatory scheme,” NRDC, 571 F.3d at 1266, then surely the reverse does, too.
So the district court was correct that “FDA’s 2016 and 2021 Changes … significantly departed from the agency’s original approval of the abortion regimen. FDA … altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.” Alliance for Hippocratic Medicine v. FDA, _ F. Supp. 3d _, 2023 WL 2825871, at *11 (N.D. Tex. Apr. 7, 2023). As a result, the 2016 and 2021 revisions triggered the reopening doctrine. Plaintiffs’ challenge to the 2000 approval is timely.
A.
Challenges to federal administrative action are subject to a six-year statute of limitations. See 28 U.S.C. § 2401(a). This six-year clock initially started ticking in March 2016, when the FDA denied Plaintiffs’ 2002 petition objecting to the 2000 approval. See 21 C.F.R. § 10.45(d). Absent reopening, Plaintiffs’ challenge to the 2000 approval would be barred by this six-year statute of limitations, because Plaintiffs filed this suit after March 2022.
But under the administrative reopening doctrine, the agency can restart the clock in two ways: (1) if “the agency opened the issue up anew, and then reexamined and reaffirmed its prior decision,” NRDC, 571 F.3d at 1265 (cleaned up), or (2) “if the revision of accompanying regulations ‘significantly alters the stakes of judicial review’ as the result of a change that ‘could have not been reasonably anticipated,’” id. at 1266 (quoting Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008)).
This second type of reopening is called “constructive reopening.” Id. I would hold that constructive reopening applies here, rendering Plaintiffs’ challenge to the 2000 approval timely.
“A constructive reopening occurs if the revision of … regulations ‘significantly alters the stakes of judicial review.’” Sierra Club, 551 F.3d at 1025 (quoting Kennecott Utah Copper Corp. v. Dep’t of the Interior, 88 F.3d 1191, 1227 (D.C. Cir. 1996)). The paradigmatic example of this is when the agency unexpectedly removes “necessary safeguards,” thus giving “new significance” to the original action. Id. at 1025–26.
In Sierra Club, the EPA’s initial 1994 rule exempted pollutant-emitting plants from emission limits when the plants were starting up, shutting down, or malfunctioning. See id. at 1022. To be eligible for the exemption, a plant had to show it was doing its “reasonable best” to stay under the emission limits. Id.
But in the early 2000s, new EPA rules removed this “reasonable best” requirement. To qualify for the exemption, plants no longer had to show they were doing their best to limit emissions. See id. at 1023. This elimination of safeguards “significantly altered the stakes of judicial review” for the environmental plaintiffs, thereby triggering reopening. Id. at 1025 (cleaned up).
The same is true here. Just as the EPA initially authorized emissions under certain safeguards to minimize harm, the FDA initially authorized mifepristone under certain safeguards to minimize harm. Remove these safeguards, and you’ve significantly altered the stakes of judicial review. The original scheme is now much more “worth challenging.” Id. at 1026 (quotation omitted).
B.
Plaintiffs’ challenge to the 2000 approval easily satisfies the reopening doctrine. Both the 2016 and 2021 revisions made significant and unexpected alterations to the basic regulatory scheme. They took away key safeguards, significantly raising the stakes of judicial review for the underlying approval.
When it approved mifepristone in 2000, the FDA included a number of “necessary safeguards” to minimize harm from this dangerous drug. Sierra Club, 551 F.3d at 1025. For example, the FDA required an in-person follow-up appointment to protect the woman from sepsis, which occurs if the child’s remains are not removed from her body after the abortion. See FDA Approval Memorandum to Population Council at 3 (Sep. 28, 2000). It also limited the use of mifepristone to the first seven weeks, ensuring that the abortion took place early in pregnancy. See id. at 1. And it required a physician to supervise the administration of mifepristone, in order to “date pregnancies and diagnose ectopic pregnancies.” Id. at 5. See also id. at 6 (same).
The 2016 amendments removed these key safeguards. By approving the abortifacient for use up to ten weeks, by allowing non-physicians to prescribe and administer the drug, and by removing the in-person follow-up requirement, the 2016 revisions significantly altered the stakes of judicial review. “These are not mere ‘minor changes.’” Sierra Club, 551 F.3d at 1025. By modifying its original restrictions, the FDA constructively reopened the drug’s approval.
The 2016 amendments became final in 2021, when the FDA denied the 2019 Petition challenging them. See 21 C.F.R. § 10.45(d). Plaintiffs’ challenge is therefore timely.
The 2021 Mail-Order Decision worked an even greater “sea change” to the “basic regulatory scheme.” NRDC, 571 F.3d at 1266. From the get-go, the FDA’s approval of mifepristone was explicitly premised on in-person dispensing. The initial 2000 approval required “[p]rovision of [the] drug through a direct, confidential physician distribution system that ensures only qualified physicians will receive the drug for patient dispensing.” FDA Approval Memorandum to Population Council at 6. See also id. at 4 (“[T]he drug will be distributed directly to physicians. It will not be available from pharmacies.”). The agency viewed this as necessary to “address[] the issue of physical security of the drug.” Id.
So “[t]he in-person dispensing requirement … was critical to FDA’s initial approval of mifepristone in 2000, which relied on the in-person dispensing requirement to dismiss concerns about provider qualifications, improper use, illicit distribution, and detection of adverse events.” Alliance for Hippocratic Medicine v. FDA, 2023 WL 2913725, at *14 (5th Cir. Apr. 12, 2023). “[T]he in-person dispensing requirement was FDA’s primary tool for ensuring the safe distribution and use of mifepristone.” Id. at *15.
“[T]his change eliminates a major safeguard against complications and adverse effects arising from improper mifepristone use.” Id. It “significantly alters the stakes of judicial review,” triggering reopening. NRDC, 571 F.3d at 1266 (quoting Sierra Club, 551 F.3d at 1025).
C.
The FDA counters that the 2016 and 2021 revisions could not have significantly altered the stakes of judicial review or made the regulatory scheme worth challenging in a way it wasn’t before. After all, the FDA says, Plaintiffs already challenged the original 2000 approval in their 2002 petition.
But not all of the Plaintiffs here participated in the 2002 petition. For those Plaintiffs, the FDA’s current regime is clearly “worth challenging,” even if the ancien régime of 2000 “may not have been” on its own. Kennecott Utah Copper Corp., 88 F.3d at 1227.
Indeed, the FDA itself has characterized the switch from one regime to the other as a “sea change.” NRDC, 571 F.3d at 1266. Under the limited stay issued by a previous panel of our court, the FDA was required to return to the regulatory regime that existed between 2000 and 2016. See Alliance, 2023 WL 2913725, at *1. The FDA vigorously protested the substitution of the 2016 and 2021 regime with the original 2000 regulations. It urged the Supreme Court to restore the 2016 and 2021 regulations by granting a stay of the entire district court order. Switching back to the 2000 restrictions, it argued, would “upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.” FDA Stay Application, 2023 WL 3127519, at *3. It would “unleash[] regulatory chaos” for “patients, prescribers, and the health care delivery system.” Id. at *2, *4.
In sum, the FDA insisted that switching from one regime to the other would “change the basic regulatory scheme.” NRDC, 571 F.3d at 1266. It claimed that switching from the 2016/2021 scheme back to the 2000 scheme counts as a sweeping change with huge stakes. The same must be true of switching from 2000 to 2016/2021—that too “upend[ed] the regulatory regime for mifepristone, with sweeping consequences.”
Plaintiffs’ challenge to the 2000 approval of mifepristone is timely.
III.
Turning to the merits, I would hold the 2000 approval unlawful. It’s a longstanding principle that agencies must follow their own regulations. See Arizona Grocery Co. v. Atchison, Topeka & Santa Fe Ry. Co., 284 U.S. 370, 386 (1932) (agency’s legislative rule “has the force of a statute”); Fort Stewart Schools v. FLRA, 495 U.S. 641, 654 (1990) (“It is a familiar rule of administrative law that an agency must abide by its own regulations.”). The FDA violated that principle when it approved mifepristone under Subpart H—as even the drug’s sponsor, the Population Council, admitted in 2000.
A.
Subpart H authorizes the FDA to approve only those drugs that treat “serious or life-threatening illnesses.” 21 C.F.R. § 314.500. See also 57 Fed. Reg. 58958 (Dec. 11, 1992) (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses). It “applies to certain new drug products 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.” 21 C.F.R. § 314.500 (emphasis added).
Pregnancy is not an illness. An “illness” is a “[b]ad or unhealthy condition of the body.” Oxford English Dictionary (2nd ed. 1989), s.v. illness, sense 3. It’s a “disease, ailment, sickness, malady.” Id. Pregnancy, by contrast, is when a woman is “with child.” Oxford English Dictionary, s.v. pregnancy, sense II.3.a.
Pregnancy is not a bad or unhealthy condition of the body—it’s a natural consequence of a healthy and functioning reproductive system. See, e.g., Gudenkauf v. Stauffer Communications, Inc., 922 F. Supp. 465, 473 (D. Kan. 1996) (“Being the natural consequence of a properly functioning reproductive system, pregnancy cannot be called an impairment.”); Lacount v. South Lewis, 2017 WL 319217, at *3 (N.D. Okla. Jan. 20, 2017) (same); Whitaker v. Bosch Braking Sys. Div. of Robert Bosch Corp., 180 F. Supp. 2d 922, 928 (W.D. Mich. 2001) (pregnancy is “not a serious health condition”); Brennan v. National Telephone Directory Corp., 850 F. Supp. 331, 343 (E.D. Pa. 1994) (“it cannot be said that [a woman’s] reproductive system is negatively affected” by pregnancy).
To be sure, pregnancy can sometimes result in illness. Cf. Spees v. James Marine, Inc., 617 F.3d 380, 397 (6th Cir. 2010) (“Pregnancy-related conditions have typically been found to be impairments where they are not part of a ‘normal’ pregnancy.”). But that does not make the pregnancy itself an illness. See Whitaker, 180 F. Supp. 2d at 929 (“pregnancy per se does not constitute a serious health condition”).
The same could be said about old age. Many people become ill as they grow older. But growing older itself is obviously not an illness. Like pregnancy, it’s the “natural consequence” of a healthy and functioning body. It’s entirely normal to celebrate pregnancies, just as it’s normal to celebrate birthdays. We don’t typically celebrate “bad or unhealthy conditions.”
So pregnancy does not qualify as a “serious or life-threatening illness” within the meaning of 21 C.F.R. § 314.500. The FDA implausibly “determined” that it does. FDA Approval Memorandum to Population Council at 6. Courts do not defer to agency interpretations of unambiguous regulations. See Kisor v. Wilkie, 139 S. Ct. 2400, 2415 (2019). There’s “only one reasonable construction” of the word “illness”—and it doesn’t include pregnancy. Id.
There is accordingly no basis for deferring to the agency. The FDA simply got it wrong. As even the sponsor of mifepristone, the Population Council, admitted, “[n]either pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.” Population Council Letter to FDA at 1–2. “The plain meaning of these terms does not comprehend normal, everyday occurrences such as pregnancy and unwanted pregnancy.” Id. at 2.
B.
The FDA does not even try to argue that pregnancy is an “illness.” Instead, the FDA, along with intervenor Danco, points out that the preamble to Subpart H uses the terms “illness,” “disease,” and “condition” interchangeably. See, e.g., 57 Fed. Reg. 58942, 58948 (“The drug in question must be for a serious or life-threatening condition.”). So they argue that Subpart H allows the FDA to approve drugs that treat life-threating conditions, as well as life-threating illnesses. And although pregnancy is plainly not an “illness,” the argument goes, pregnancy is at least a “condition.”
There are two problems with this argument. First, we do not use preambles to expand the meaning of clear regulatory text. See District of Columbia v. Heller, 554 U.S. 570, 578 n.3 (2008) (“[I]n America ‘the settled principle of law is that the preamble cannot control the enacting part of the statute in cases where the enacting part is expressed in clear, unambiguous terms.’”); Antonin Scalia & Bryan A. Garner, {{sc|Reading Law}] 218 (2012) (“[T]he prologue cannot give words and phrases of the dispositive text a meaning that they cannot bear.”).
Second, this argument—that the preamble broadens “illness” to include “conditions”—equivocates between two distinct meanings of the word “condition.” As used in the preamble, “condition” means a “defective state of health.” Merriam-Webster’s Collegiate Dictionary (11th ed. 2007), s.v. condition, sense 4c. In this sense, “condition” is a synonym of “illness.” See Merriam-Webster’s Collegiate Thesaurus (1988), s.v. condition, sense 6 (listing “disease,” “aliment,” and “sickness” as synonyms of “condition”).
Of course, “condition” can also mean “a state of being” more broadly. Merriam-Webster’s Collegiate Dictionary, s.v., condition, sense 4a. And pregnancy is certainly a “condition” in this broader sense.
But the fact that pregnancy is a “condition” in the broad sense of “state of being” does not make it a “condition” in the narrow sense “illness.” And Subpart H plainly contemplates the narrow sense, because it uses “condition” interchangeably with “illness.” A regulation about “cars” doesn’t cover bicycles just because its preamble sometimes mentions “vehicles.” Likewise, a regulation about “illnesses” doesn’t address pregnancy just because its preamble sometimes mentions “conditions.”[1]
C.
The agency’s brief proclaims that “FDA Properly Approved Mifepristone Under Subpart H.” Yet in the very next paragraph, the FDA turns around and denies that it used Subpart H to approve mifepristone—claiming that the approval was “based on FDA’s statutory authority under 21 U.S.C. § 355, not Subpart H.”
As the panel majority opinion details, Subpart H encompasses two different paths. The first is entitled “Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.” 21 C.F.R. § 314.510 (emphasis omitted). The second is entitled “Approval with restrictions to assure safe use.” 21 C.F.R. § 314.520 (emphasis omitted).
Mifepristone was approved under § 314.520 of Subpart H—approval with restrictions. But the FDA now suggests that § 314.520 isn’t really a method of approval at all—it’s just a method of adding restrictions on use.
This argument is belied by the regulations. The header explicitly refers to this second path as a method of “[a]pproval.” Id. § 314.520. More importantly, the regulatory text repeatedly refers to § 314.520 as a method of drug approval. See id. § 314.530(a) (“new drugs approved under … 314.520”); id. § 314.530(b) (“an application approved under … § 314.520”); id. § 314.560 (“drug products approved under § 314.520”).
The FDA’s argument contradicts not only the text, but also its own statements over the past 23 years. See Chenery, 318 U.S. at 95; Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29, 50 (1983) (“[C]ourts may not accept appellate counsel’s post hoc rationalizations for agency action.”).
In its original 2000 approval memo, the FDA expressly stated that “[t]his drug is being approved under Subpart H.” FDA Approval Memorandum to Population Council at 8. And it has repeatedly reaffirmed this view in the years since. See FDA Supplemental Approval Letter to Danco Labs at 1 (June 6, 2011) (application “approved under the provisions of 21 CFR 314.520 (Subpart H)”); FDA Letter Denying 2002 Citizen Petition at 2 (Mar. 29, 2016) (“The application was approved under 21 CFR part 314, subpart H.”); FDA Letter Denying 2019 Citizen Petition at 2 (Dec. 16, 2021) (same).
The GAO report cited by both the FDA and Danco likewise repeatedly describes mifepristone as having been “approved” under Subpart H. GAO, Approval and Oversight of the Drug Mifeprex at 1 (Aug. 2008) (“FDA approved the drug under a provision of the agency’s Subpart H regulations.”); id. at 5 (“FDA approved Mifeprex under the restricted distribution provision of its Subpart H regulations.”); id. at 6 (FDA “approved the Mifeprex [application] under Subpart H.”). See also id. at 10, 14–15, 21–24, 32, 44 (same). The report also notes that the FDA used Subpart H to “approve” other drugs. See id. at 5 n.13, 25 n.46, 27 n.50, 29 n.53, 36 n.63. And it explicitly refers to § 314.520 as an “approval provision.” Id. at 1 n.2.
The FDA notes that its statutory authority to approve drugs comes from 21 U.S.C. § 355. But that doesn’t change the fact that the regulatory path it chose was Subpart H. Section 355 gives the FDA the power to approve drugs. And the agency exercised that power when it promulgated Subpart H. The FDA did not have to adopt Subpart H in the first place. But once it did, it was bound to follow it.
D.
As a final defense, the FDA contends that subsequent events cured any defects in its initial 2000 approval. Specifically, the FDA points to the 2007 Food and Drug Administration Amendments Act and to the agency’s 2011 Risk Evaluation and Mitigation Strategy. It claims that both authorities render any faults with the 2000 approval irrelevant.
First, the FDA argues that the 2007 Act “deemed” mifepristone to be approved. But the statutory text contradicts this argument. The Act makes clear that “[a] drug that was approved before the effective date of this Act is … deemed to have in effect an approved risk evaluation and mitigation strategy … if there are in effect on the effective date of this Act elements to assure safe use … required under [21 C.F.R. §] 314.520.” Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, tit. IX § 909(b)(1), 121 Stat. 823, 950 (emphasis added).
So the Act itself did not approve any drugs. It only approved any risk evaluation and mitigation strategies for those drugs that the FDA had already validly approved under § 314.520 of Subpart H. And as explained above, the FDA’s attempted approval was invalid because it failed to comply with Subpart H. The FDA’s reliance on the 2007 Act is entirely circular—it only works if you assume that the agency had already validly approved mifepristone in the first place.
The FDA also points to its 2011 Risk Evaluation and Mitigation Strategy, arguing that this too re-approved mifepristone and cured any defects in its 2000 approval. It did not. To the contrary, the 2011 REMS letter made clear that the agency continued to rely on Subpart H for its approval of mifepristone—that it “is approved under the provisions of 21 CFR 314.520 (Subpart H).” FDA Supplemental Approval Letter to Danco Labs at 1. Moreover, the letter only approved the Risk Evaluation and Mitigation Strategy proposed in Danco’s 2008 Supplemental Application—it did not re-approve the drug apart from Subpart H. In fact, the letter recognized the need for continued compliance with the conditions “required by” Subpart H. Id. at 2 (citing 21 C.F.R. § 314.550). *** For these reasons, I would find that Plaintiffs are likely to succeed on the merits of their challenge to the 2000 approval. Plaintiffs also satisfy the remaining factors for equitable relief. The harm to Plaintiffs is irreparable. No relief at law can adequately address Plaintiffs’ conscience injuries. See BST Holdings, L.L.C. v. OSHA, 17 F.4th 604, 618 (5th Cir. 2021). Nor can money damages remedy the destruction of life. Cf. Amoco Production Co. v. Village of Gambell, 480 U.S. 531, 545 (1987). The balance of equities and public interest also favor Plaintiffs. Plaintiffs seek to vindicate the “national policy of discountenancing abortion as inimical to the national life,” as reflected in Congressional enactments including the Comstock Act. Bours v. United States, 229 F. 960, 964 (7th Cir. 1915). See 18 U.S.C. § 1461; id. § 1462. Cf. 19 U.S.C. § 1305(a).
IV.
With respect to the FDA’s 2016 and 2021 revisions, I agree with the majority’s thoughtful analysis explaining how the FDA “entirely failed to consider an important aspect of the problem” in 2016 and “offered an explanation for its decision that runs counter to the evidence before the agency” in 2021. State Farm, 463 U.S. at 43. The agency thus acted arbitrarily in violation of the APA.
I write separately to add that the 2021 revisions violate the Comstock Act, 18 U.S.C. §§ 1461–62, and are “not in accordance with law” for that reason as well. 5 U.S.C. § 706(2)(A).
A.
The text of the Comstock Act prohibits the mailing of abortifacient drugs:
Every article or thing designed, adapted, or intended for producing abortion … and [e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion … [i]s declared to be nonmailable matter and shall not be conveyed in the mails or delivered from any post office or by any letter carrier.
Whoever knowingly uses the mails for the mailing, carriage in the mails, or delivery of anything declared by this section … to be nonmailable … shall be fined under this title or imprisoned not more than five years, or both, for the first such offense, and shall be fined under this title or imprisoned not more than ten years, or both, for each such offense thereafter.
18 U.S.C. § 1461. This language derives from the original 1873 Comstock Act. See Act of Mar. 3, 1873, ch. 258, § 2, 17 Stat. 598, 599 (“No … article or thing designed or intended for the … procuring of abortion … shall be carried in the mail.”).
Congress later extended the mailing prohibition to cover common carriers as well. See Act of Feb. 8, 1897, ch. 172, 29 Stat. 512, 512 (“[I]t shall be unlawful for any person to deposit with any express company or other common carrier … any article or thing designed or intended for the … procuring of abortion.”). As currently in force, this provision states:
Whoever brings into the United States … or knowingly uses any express company or other common carrier or interactive computer service … for carriage in interstate or foreign commerce … any drug, medicine, article, or thing designed, adapted, or intended for producing abortion … or [w]hoever knowingly takes or receives, from such express company or other common carrier or interactive computer service … any matter or thing the carriage or importation of which is herein made unlawful … [s]hall be fined under this title or imprisoned not more than five years, or both, for the first such offense and shall be fined under this title or imprisoned not more than ten years, or both, for each such offense thereafter.
18 U.S.C. § 1462.
In 1996, Congress added “interactive computer service” to the Comstock Act. See Telecommunications Act of 1996, Pub. L. No. 104-104, § 507(a), 110 Stat. 56, 137. So it’s also illegal to use the internet to ship or receive abortifacients. See 18 U.S.C. § 230(f)(2) (defining “interactive computer service”); id. § 230(f)(3) (“interactive computer service” includes “the Internet”); Doe v. MySpace, Inc., 528 F.3d 413, 415 (5th Cir. 2008) (“interactive computer service” includes “a Web site”).
The FDA’s 2021 Mail-Order Decision violates the Comstock Act. That decision authorizes the dispensing of mifepristone “through the mail … or through a mail-order pharmacy.” FDA Letter to American College of Obstetricians and Gynecologists at 2 (Apr. 12, 2021). But “us[ing] the mails for the mailing” of a “drug … for producing abortion” is precisely what the Comstock Act prohibits. 18 U.S.C. § 1461. See Alliance, 2023 WL 2913725, at *20 (“[A] user of those shipping channels violates the plain text merely by knowingly making use of the mail for a prohibited abortion item.”).
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.
Next, the FDA claims that the Comstock Act prohibits sending abortifacients only when they are used in violation of state law. To support this theory, it relies on a handful of early twentieth century cases outside our circuit. See Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, 46 Op. O.L.C. _, _ (Dec. 23, 2022) (collecting cases).
But the earliest case it cites, Bours v. United States, 229 F. 960 (7th Cir. 1915), rejects the FDA’s position. Bours says that “it is immaterial what the local statutory definition of abortion is, what acts of abortion are included, or what excluded.” Id. at 964. Rather, “the word ‘abortion’ in the national statute must be taken in its general medical sense.” Id. And “[i]ts inclusion in the statute governing the use of the mails indicates a national policy of discountenancing abortion as inimical to the national life.” Id. Under Bours, the Act’s definition of “abortion” excludes “operation[s]” that are necessary to “save [the mother’s] life.” Id. But anyone who uses the mails to “destroy[] life” violates the statute. Id.
So the FDA can’t invoke the prior-construction canon. Under that canon, legislative reenactment of a statute can, under certain conditions, effectively ratify preexisting, authoritative judicial interpretation of that statute. But the canon requires robust judicial consensus, such as “uniform holdings of lower courts.” Scalia & Garner, supra, at 324. See, e.g., Armstrong v. Exceptional Child Ctr., Inc., 575 U.S. 320, 330 (2015) (quoting Bragdon v. Abbott, 524 U.S. 624, 645 (1998)) (canon applies when “judicial interpretations have settled the meaning of an existing statutory provision”) (emphasis added); Tex. Dep’t of Housing & Community Affairs v. Inclusive Communities Project, Inc., 576 U.S. 519, 536 (2015) (“Congress accepted and ratified the unanimous holdings of the Courts of Appeals.”) (emphasis added). The FDA can claim no such consensus here. To the contrary, the circuits were at best split. Bours rejects the FDA’s reading of the statute. And the amicus brief from the Ethics and Public Policy Center puts forth a strong argument that no circuit court adopted the FDA’s reading.
What’s more, Congress certainly knew how to prohibit only those abortifacients used to violate state law. The Tariff Act of 1930, for example, prohibits all persons “from importing … any drug or medicine or any article whatever for causing unlawful abortion.” 19 U.S.C. § 1305 (emphasis added). See also Act of June 17, 1930, ch. 497, tit. III, § 305, 46 Stat. 590, 688 (same). In response, the FDA suggests that it would be irrational for Congress to target all abortions in the Comstock Act, but only unlawful abortions in the Tariff Act. But different Congresses can reach different judgments about how to regulate abortion in different contexts. There’s nothing irrational about the Congress that enacted the Comstock Act in 1873 making a different judgment from the Congress that enacted the Tariff Act decades later.
Moreover, Congress has actually considered amending the Comstock Act to apply only to “illegal abortions”—and chosen not to. In 1978, Congress rejected a proposed Comstock Act amendment to prohibit the shipment of “any drug, medicine, article, or thing, with the intent that such drug, medicine, article, or thing be used to produce an illegal abortion.” H.R. 13959, 95th Cong. § 6702(1)(C)(i) (1978) (emphasis added). See also id. 6701(a)(2) (same). A contemporaneous Congressional report explained:
[R]evised title 18 changes current law by requiring proof that the relevant material or object to be used to produce an illegal abortion and that the offender specifically intended the material object to be so used. … [A]n abortion is “illegal” if it is contrary to the law of the state in which the abortion is performed.
Report of the Subcommittee on Criminal Justice on Recodification of Federal Criminal Law, H.R. Rep. No. 95-29, pt. 3, at 42 (1978) (emphasis added).
Congress also had the opportunity to remove “abortion” from the Comstock Act altogether. See Comstock Cleanup Act of 1996, H.R. 3057, 104th Cong. (1996). See also 142 Cong. Rec. 24313, 24313 (Sep. 24, 1996) (statement of Rep. Pat Schroeder, sponsor of H.R. 3057) (“[T]he Comstock Act has never been repealed; it is still on the books.”); id. at 24313–14 (“[T]his body just allowed the Comstock Act to be enforced on the Internet vis-à-vis anything doing with abortion. … The Telecommunications Act passed this year extended the Comstock Act’s prohibitions to anyone who uses an interactive computer service.”). But again, Congress declined to remove “abortion” from the statute. To the contrary, it chose to repeal only the Act’s prohibition on the shipment of contraceptives. See Pub. L. No. 91662, §§ 3–4, 84 Stat. 1973, 1973 (1971).
So if the FDA wants us to look to the post-enactment history of the Comstock Act rather than its text, that history only reinforces the natural reading of the text. I would set aside the 2021 Mail-Order Decision because it violates the Comstock Act.
V.
In this appeal, neither the FDA nor Danco is content to simply argue that the district court erred. They disparage the ruling as “an unprecedented judicial assault on a careful regulatory process.” The “non-expert” district court issued an “unprecedented order countermanding the scientific judgment of the Food and Drug Administration.”
Their message is simple: The scientists at the FDA can do no wrong. So courts have no business reviewing their actions.
That’s mistaken on multiple levels.
To begin with, Congress has directed the judiciary to review the legality of regulatory action by the FDA, no less than with other agencies. Congress could have exempted the FDA generally—or its approval of drugs specifically—from APA review. See 5 U.S.C. § 701(a)(1) (no APA review where “statutes preclude judicial review”). But it didn’t—and for understandable reasons.
Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They’re not perfect. See, e.g., Whole Woman’s Health v. Paxton, 10 F.4th 430, 464–70 (5th Cir. 2021) (en banc) (Ho, J., concurring). None of us are. We all make mistakes.
And the FDA has made plenty. Several of the FDA’s past mistakes are detailed in the amicus briefs from the United States Medical Association and the Association of American Physicians and Surgeons Educational Foundation. I’ll highlight just a few examples here.
Earlier this year, the FDA was forced to pull the drug Makena from the market. See FDA News Release: FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena (Apr. 6, 2023). The FDA had approved this drug in 2011 to treat premature birth, using Subpart H. See Frank J. Sasinowski & Alexander J. Varond, FDA’s Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence, 71 Food & Drug L.J. 135, 167 (2016). Yet the drug turned out to have “no benefit for mothers or babies.” Christina Jewett, Preterm Birth Drug Withdrawn After 12 Years, N.Y. Times (Mar. 7, 2023). As one headline put it, “F.D.A. Rushed a Drug for Preterm Births. Did it Put Speed Over Science?” Christina Jewett, N.Y. Times (Mar. 25, 2022). “Makena is another example … of a medication fast-tracked by the [FDA] onto the market even though considerable doubt remained about whether it worked.” Id. (Makena involved the other Subpart H approval pathway—approval with a surrogate endpoint, not approval with restrictions. But an agency that relies on bad science for approval under one Subpart H pathway can surely do so under the other as well.)
The FDA hasn’t just approved ineffective drugs—it’s also approved harmful drugs. In 1941, for example, it approved DES for use by pregnant women to treat certain postpartum conditions. Several years later, the FDA approved it to prevent miscarriages as well. The FDA’s approval has since been called a “tragedy.” Jessica Dye, FDA Outlines Initiatives Inspired by DES ‘Tragedy’, Law360 (Feb. 24, 2011). “Even before the [FDA] approved the drug in 1941, researchers knew that DES caused cancer and problems with sexual development in laboratory animals.” Nancy Langston, The Retreat from Precaution: Regulating Diethylstilbestrol (DES), Endocrine Disruptors, and Environmental Health, 13 Environmental History 41, 42 (2008). “These concerns initially led [the] FDA Commissioner … to reject the drug.” Id. But “by 1947, the FDA had abandoned its position of precaution.” Id.
Only in 2000 did FDA finally and formally “withdraw[] approval” of DES—nearly six decades after it approved the drug. 65 Fed. Reg. 55264 (“Withdrawal of Approval of 28 New Drug Applications”). DES turned out to be a carcinogen. See Diethylstilbestrol (DES) Exposure and Cancer, Nat’l Cancer Inst. (Dec. 20, 2021). It also significantly increases the odds of infertility, miscarriage, stillbirth, and neonatal death. See id.
The FDA has been blamed for contributing to the opioid crisis. Opioid overdose was “once rare” in the United States. Andrew Kolodny, How FDA Failures Contributed to the Opioid Crisis, 22 AMA J. Ethics 743, 743 (2020). But now “the vast oversupply of opioid drugs in the United States has caused a plague.” In re Nat’l Prescription Opiate Litigation, 927 F.3d 919, 924 (6th Cir. 2019) (approvingly quoting the district court). As one noted scholar observed in the AMA Journal of Ethics, “[t]he FDA did not properly enforce the Food, Drug, and Cosmetic Act when it approved Purdue Pharma’s new drug application for extended-release (ER) oxycodone in 1995.” Kolodny, supra, at 744. And “despite mounting evidence that a surge in opioid consumption was resulting in adverse public health consequences, the FDA continued to approve new opioid formulations for chronic pain based on efficacy trials utilizing a controversial methodology.” Id. at 745. It wasn’t just that the studies were bad—the FDA suffered from regulatory capture by the pharmaceutical industry, which pursued its own interest rather than the interest of the American people. See id. at 745–46.
Finally, consider this statistic from the Journal of the American Medical Association: Of all the novel therapeutics approved by the FDA in the decade following its approval of mifepristone, nearly one-third experienced safety issues. See Nicholas S. Downing et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010, 317 J. Am. Med. Ass’n 1854, 1854 (2017).
Problems at the FDA have not escaped Congress’s attention. Just last year, the chair of the Senate Committee on Health, Education, Labor, and Pensions criticized the FDA for its “unacceptable, longstanding” food safety failures. Letter of Senator Patty Murray, Chair, Senate Committee on Health, Education, Labor, and Pensions to FDA Commissioner (Apr. 11, 2022). As she put it, “[t]he FDA’s failure over decades to regulate and enforce food safety standards … has put the health of Americans at risk.” Id.
So it’s not surprising that our court is far from the first to identify problems with FDA action sufficient to necessitate judicial intervention. Courts have held a number of FDA actions unlawful under the APA—including drug approval. See, e.g., Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1078 (D.C. Cir. 2001) (“Appellant argues that the [FDA’] decision to approve … [an] Abbreviated New Drug Application (ANDA) for a generic version … was arbitrary and capricious. We agree and vacate that approval.”). See also, e.g., R.J. Reynolds Vapor Co. v. FDA, 65 F.4th 182, 191 (5th Cir. 2023) (FDA’s “‘unexplained’ and ‘inconsistent’ positions are likely arbitrary and capricious.”); Genus Medical Technologies, LLC v. FDA, 994 F.3d 631, 644 (D.C. Cir. 2021) (“FDA’s decision must be set aside because it was based on an erroneous interpretation of law.”); Teva Pharmaceuticals, Inc. v. Sebelius, 595 F.3d 1303, 1318 (D.C. Cir. 2010) (rejecting “the interpretation of the statute that the FDA has adopted in two recent adjudications”); Teva Pharmaceuticals, Inc. v. FDA, 441 F.3d 1, 5 (D.C. Cir. 2006) (“This error renders [the FDA’s] decision arbitrary and capricious.”); Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877, 883–84 (D.C. Cir. 2004) (“FDA’s conclusion … was arbitrary and capricious.”); Teva Pharmaceuticals, Inc. v. FDA, 182 F.3d 1003, 1007 (D.C. Cir. 1999) (“FDA’s response was arbitrary and capricious.”); Zotos International, Inc. v. Young, 830 F.2d 350, 354 (D.C. Cir. 1987) (“FDA’s decision was arbitrary and capricious.”); Rhodia, Inc. v. FDA, 608 F.2d 1376, 1376 (D.C. Cir. 1979) (“Finding the action arbitrary and capricious, we set aside the FDA order.”); Natural Nutritional Foods Ass’n v. Mathews, 557 F.2d 325, 333 (2nd Cir. 1977) (“[T]he FDA’s holding in this case was arbitrary and capricious and not in accordance with law.”).
So it’s simply wrong to claim—as the FDA and Danco and their supporting amici here have claimed—that the district court’s decision in this case was unprecedented.
The scientists at the FDA deserve our respect and our gratitude, but not our blind deference. That would defy Congress’s clear directive that courts conduct independent legal review of FDA action under the APA.
*** By the applicant’s own admission, the FDA used an unlawful procedure when it approved mifepristone. And the agency’s later regulations are likewise invalid—both under the APA as the majority outlines, and under the Comstock Act as well. In sum, the regulations are “not in accordance with law” and therefore must be set aside. 5 U.S.C. § 706(2)(A).
Accordingly, we should affirm. I concur in part and dissent in part.
- ↑ Danco responds by citing a Government Accountability Office report, which observes that the FDA has used Subpart H to approve drugs for treating “breakthrough cancer pain, specific symptoms of narcolepsy, and severe acne.” GAO, Approval and Oversight of the Drug Mifeprex at 10 (Aug. 2008). “Severe recalcitrant nodular acne” may well be a serious illness. Id. at 44. But that has nothing to do with whether pregnancy is a serious or life-threatening illness.