Mifepristone and the rule of law
The plaintiffs' case to take mifepristone off the market is weak and likely to fail.
In 2000, the FDA approved a drug known as mifepristone for purposes of terminating pregnancies through 49 days’ gestation. The FDA concluded that mifepristone, when used in conjunction with a different drug called misoprostol, was safe and effective, and that the benefits of mifepristone exceeded the risks.
In November 2022, a group of plaintiffs, led by the Alliance for Hippocratic Medicine, filed a federal lawsuit in the Northern District of Texas seeking to overturn the FDA’s approval of mifepristone and force mifepristone off the market. The plaintiffs have filed a motion for a preliminary injunction, which is currently pending in the district court.
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This lawsuit has gotten considerable attention from the press. Many articles have accused the presiding district judge of being biased based on his legal advocacy before his appointment as well as second-hand descriptions of his personal views. I view these attacks as inappropriate and unfair: the judge was entitled to represent whatever clients he wished before ascending the bench, and I see no basis for believing that the judge will act in bad faith in this case or any other.
I would prefer that commentary focused on the legal merits of the lawsuit, and that will be the subject of this post. Cutting to the chase: the plaintiffs’ legal theory is remarkably weak. Basic principles of administrative law, having nothing to do with abortion, squarely foreclose the plaintiffs’ claims.
I will not venture a prediction on how the Northern District of Texas or the Fifth Circuit will rule. If the plaintiffs prevail in those courts, however, the Justice Department is likely to seek emergency relief from the Supreme Court. In my view, the Justice Department will likely prevail. If the subject matter of this case were anything other than abortion, the plaintiffs would have no chance of succeeding in the Supreme Court. The plaintiffs are banking on the hope that because this is a case about abortion, the Court will bend ordinary principles of administrative law. I predict it will not.
There are at least four problems with the plaintiffs’ suit:
The plaintiffs’ theory of standing is irreconcilable with Supreme Court precedent.
The statute of limitations has expired on plaintiffs’ challenge to the FDA’s approval of mifepristone. The plaintiffs claim that the FDA “constructively reopened” that approval in 2016, thus restarting the statute of limitations, but that’s clearly wrong.
The plaintiffs did not exhaust their claims, even though a regulation explicitly required them to do so.
Although the plaintiffs claim that the FDA’s actions are contrary to the Food, Drug, and Cosmetic Act (FDCA), the plaintiffs have failed to identify any particular provision of the FDCA that the FDA has actually violated.
Let’s walk through each of those issues one by one.
The plaintiffs lack standing
Under Article III of the Constitution, the plaintiffs must have standing to sue. This means they must show a concrete and particularized injury caused by the challenged conduct, that would be redressable by the remedy they seek.
The plaintiffs are associations of doctors suing on behalf of their doctor members, as well as individual doctors. (The associations claim to be suing on behalf of patients too, but they don’t seem to have any patients as members, or at least patients who represent that they might consider taking mifepristone.) The plaintiff-doctors’ theory of standing is, in a nutshell, that if mifepristone stays on the market, other doctors will prescribe mifepristone to their pregnant patients, the pregnant patients will suffer side effects, and then the patients will switch doctors and come to the plaintiff-doctors. This, in turn, will injure the plaintiff-doctors because it will divert their attention from their other patients, potentially force them to complete “unfinished abortions,” and possibly expose them to malpractice lawsuits. By contrast, if mifepristone is off the market, these women will elect to carry their babies to term (as opposed to seeking surgical abortions), thus preventing the plaintiff-doctors from facing these risks.
There is an irony in the fact that conservative-leaning groups are pursuing such a roundabout theory of standing. In the past, it was progressive interest groups that supported extremely broad theories of standing, with conservative interest groups arguing for more rigorous enforcement of Article III. The conservative view prevailed at the Supreme Court, and in view of the Supreme Court’s decisions in this area, I cannot comprehend how one can find standing on the facts of this case.
Let’s start with Clapper v. Amnesty International USA, 568 U.S. 398 (2013), a 5-4 opinion by Justice Alito, joined by the Chief Justice and Justices Scalia, Thomas, and Kennedy. After 9/11, Congress enacted legislation making it easier for the Justice Department to surveil foreign nationals’ telephone and email communications for purposes of gathering intelligence. The plaintiffs were lawyers and media organizations who regularly communicated with foreign terrorists, such as Khalid Sheikh Mohammed and other Guantanamo detainees. The plaintiffs argued they had standing to challenge the legislation because it was probable that their communications would be surveilled; the whole point of the statute was to monitor the communications of foreign terrorists. The Second Circuit found that the plaintiffs had standing based on the “objectively reasonable” likelihood their communications would be intercepted. Justice Breyer’s dissent agreed with this position: “We need only assume that the Government is doing its job (to find out about, and combat, terrorism) in order to conclude that there is a high probability that the Government will intercept at least some electronic communication to which at least some of the plaintiffs are parties.”
A “high probability” is not good enough, said the Court. According to the Court, “threatened injury must be certainly impending to constitute injury in fact,” and “allegations of possible future injury are not sufficient.” (Italics in original.) The Court continued: “The Second Circuit's ‘objectively reasonable likelihood’ standard is inconsistent with our requirement that ‘threatened injury must be certainly impending to constitute injury in fact.’”
Stop right there. At most the doctors can show an “objectively reasonable likelihood” of harm. I seriously doubt they could show even that: Among other things, they have to bootstrap their theory on the merits (mifepristone is dangerous) to a theory of standing (because mifepristone is dangerous, they will get additional patients who are harmed by mifepristone). They also have to speculate that patients who took mifepristone will switch doctors to them—pro-life doctors whose mission is to take mifepristone off the market. And then they have to speculate that exposure to these hypothetical patients will cause them some kind of harm (doctors are not usually “harmed” by seeing patients and are usually able to juggle multiple patients). But even if one agrees that these outcomes are likely, it cannot possibly be “certainly impending” that these hypothetical patients will have side effects, switch to new doctors, and divert the doctors’ attention from the doctors’ other hypothetical patients.
Let’s look at some more of Clapper’s reasoning. Clapper quotes language from the plaintiffs’ affidavits saying that they “have to assume that every one of our international communications may be monitored by the government.” This, according to the Court, does not support standing because there are “no specific facts demonstrating that the communications of their foreign contacts will be targeted,” and because the government does not have to monitor the communications, the “allegations are necessarily conjectural.”
That reasoning ends this case. The doctors are assuming that these hypothetical future patients will come to them, but they certainly have no specific facts demonstrating that any particular patient will come to them. Obviously these facts are impossible for the doctors to provide, but it was equally impossible for the plaintiffs in Clapper to provide such facts (the hypothetical communications were both classified and in the future), and yet the absence of those facts doomed the Clapper plaintiffs’ case.
If you are not persuaded, take a look at Summers v. Earth Island Institute, 555 U.S. 448 (2009), a 5-4 decision with the same Justices in the majority as Clapper. The plaintiffs were environmental associations challenging Forest Service regulations that exempted fire-rehabilitation and timber-salvage projects from notice-and-comment rulemaking. The associations’ members—numbering in the hundreds of thousands—were people who used national forests for recreational purposes. The associations’ members had already been harmed by one such timber-salvage project, and given that the regulations continued to be in force, they were bound to be harmed by future projects that the regulations facilitated.
Four dissenting Justices would have found standing. Justice Breyer’s dissent explained: “the Forest Service admits that it intends to conduct thousands of further salvage-timber sales and other projects exempted under the challenged regulations.” And, the plaintiffs had already been harmed by a salvage-timber sale that occurred in the past pursuant to those regulations. Justice Breyer asked: “How then can the Court deny that the plaintiffs have shown a ‘realistic’ threat that the Forest Service will continue to authorize (without the procedures claimed necessary) salvage-timber sales, and other Forest Service projects, that adversely affect the recreational, esthetic, and environmental interests of the plaintiffs' members?” Of course, the plaintiffs could not pinpoint which member would be harmed or where the future salvage-timber sale would be, but Justice Breyer observed: “a threat of future harm may be realistic even where the plaintiff cannot specify precise times, dates, and GPS coordinates.”
Not good enough for standing, said the majority. As Justice Scalia, writing for the Court, put it in characteristically colorful fashion: “The dissent proposes a hitherto unheard-of test for organizational standing: whether, accepting the organization's self-description of the activities of its members, there is a statistical probability that some of those members are threatened with concrete injury.” According to the Court, “[t]his novel approach to the law of organizational standing would make a mockery of our prior cases, which have required plaintiff-organizations to make specific allegations establishing that at least one identified member had suffered or would suffer harm.”
It is impossible to reconcile the plaintiff medical organizations’ theory of standing with this reasoning. The organizations contend that because mifepristone is statistically likely to cause side effects that will in turn cause pregnant women to switch doctors, its members are statistically likely to see patients who have been harmed by mifepristone abortions. This approach to standing is exactly the approach that the Court said would “make a mockery” of standing in Summers. I cannot understand how the harm to the doctors is “certainly impending” when the harm to the environmentalists in Summers was not. As for the individual doctor plaintiffs, I cannot understand how they can say that it is “certainly impending” that they will see, and be injured by, such hypothetical future patients.
Moreover, the logical implication of the plaintiffs’ position is that medical organizations have standing to challenges literally all rules that are alleged to decrease safety in any way. Suppose OSHA lifts some safety standard. A medical organization can sue claiming that (1) this will make workplaces less safe, (2) hypothetical injured employees will come to the doctor-members, and (3) the doctor-members’ attention to their current patients will be diverted. Or suppose EPA alters some pollution rule. A medical organization can sue claiming that (1) this will cause people to breathe in more toxins, (2) hypothetical people who breathe in these toxins will seek medical care and come to the doctor-members, and (3) the doctor-members’ attention to their current patients will be diverted.
Usually slippery slope arguments don’t work because courts are able to find a limiting principle, but here, none exists—plaintiffs’ argument is logically identical to those arguments. It’s interesting to note that the defendants’ brief makes this slippery-slope argument, and the plaintiffs’ reply brief ignores it altogether. They have to ignore it, because there are no responses to it.
The plaintiff organizations also offer an alternative theory of standing. They claim that the organizations themselves (as opposed to the organizations’ members) have been harmed because they have been forced to divert “time, energy, and resources” from their missions in order to educate people about the dangers of mifepristone, which they wouldn’t have to do if mifepristone was off the market. According to the organizations, if there were no mifepristone, the organizations could do other things, such as educate the world over the dangers of surgical abortions.
Once again this theory is directly contrary to Clapper. In Clapper the plaintiffs made the exact same argument—because of the risk of surveillance, they had to divert resources to guard against the surveillance, transforming a conjectural injury into a concrete dollars-and-cents injury. The Supreme Court rejected this argument based on the following reasoning:
This improperly waters down the fundamental requirements of Article III. Respondents' contention that they have standing because they incurred certain costs as a reasonable reaction to a risk of harm is unavailing— because the harm respondents seek to avoid is not certainly impending. In other words, respondents cannot manufacture standing merely by inflicting harm on themselves based on their fears of hypothetical future harm that is not certainly impending.
That reasoning could be written for this case. Because the plaintiffs don’t face “certainly impending” harm from mifepristone, they can’t manufacture standing by taking actions to educate people about the risk of mifepristone.
Moreover, the slippery-slope concern is even starker here. If the plaintiffs’ theory was correct, literally any organization could sue over any rule in the entire world. All they have to do is: (1) say they disagree with the rule and it’s harmful, and (2) say they’re incurring injuries by educating people about the bad rule, thus (3) diverting their attention from doing other things.
Maybe if Summers and Clapper had gone the other way, the plaintiffs would have had a case. After Summers and Clapper, they don’t. True, the plaintiff organizations in Summers and Clapper were progressive-leaning organizations and the plaintiff organizations here are conservative-leaning organizations, but the rule of law requires like cases to be treated alike.
The statute of limitations has expired
Believe it or not, standing actually isn’t the weakest part of the plaintiffs’ case.
If I had to choose the single biggest weakness in the plaintiffs’ case, it’s that the statute of limitations has expired. The FDA approved mifepristone in 2000. According to the FDA’s regulations, a plaintiff seeking to challenge an agency decision is required to file a citizen petition raising its arguments to the agency. See 21 C.F.R. § 10.45(b). If the citizen petition is denied, the plaintiff can sue, subject to a six-year statute of limitations.
In this case, two of the plaintiff organizations did submit citizen petitions challenging the FDA’s approval of mifepristone in 2000. After a long delay, the FDA denied the petitions in March 2016. This gave the organizations until March 2022 to sue. They sued in November 2022.
As we frequently learn in law school, one of the benefits of clear rules over discretionary standards is that clear rules allow judges of different jurisprudential views to agree on how cases should be resolved, even when the underlying subject matter is controversial. This case shows that principle at work. While judges have widely divergent views about abortion, Republican and Democratic appointees can come together in agreement that November 2022 is later than March 2022.
How do the plaintiff organizations try to get around this problem? By relying on a doctrine known as the “constructive reopening” doctrine.
In 2016, the FDA approved a supplemental application to alter certain of the conditions of mifepristone’s approval. The FDA increased the gestational age limit from 49 to 70 days, reduced the number of required in-person clinic visits to one, and allowed healthcare providers other than doctors to prescribe it.
In 2019, the plaintiffs filed a citizen petition to challenge the FDA’s approval of that supplemental application, which the FDA denied in 2021. The plaintiffs then filed a lawsuit within six years of that denial.
The plaintiffs’ theory is that by filing a lawsuit to challenge the 2016 approval of the supplemental application, they also get to challenge the 2000 approval of the original application, even though the statute of limitations on a direct challenge to the 2000 approval has expired. The plaintiffs’ theory is that in granting the 2016 application and subsequently denying the citizen petition, the FDA “reopened” the 2000 approval, which restarts the six-year clock on challenging the 2000 approval.
However, there is absolutely nothing in the 2016 approval and 2021 denial suggesting that the FDA was reconsidering or reopening its 2000 decision to approve mifepristone. Instead, it is clear from reading these decisions that the FDA started from the premise that its 2000 decision was correct and that mifepristone is indeed safe and effective. Based on that starting premise, it undertook to decide whether access to mifepristone should be expanded.
The plaintiffs do not claim that the agency ever said, or even implied, in the 2016 and 2021 decisions that it was reopening the 2000 approval. Instead, the plaintiffs argue that the FDA “constructively” reopened the 2000 approval.
In general, the fact that a plaintiff resorts to an argument that the government “constructively” did a thing is a pretty good sign that the government did not, in fact, do that thing.
That is so in this case. The plaintiffs’ theory makes no logical sense. Why would a decision expanding access to a drug “constructively” reopen a decision to approve that drug? That’s not the way science, or regulation, works.
Scientists routinely do research that builds off of prior research without “constructively reopening” that prior research. A scientist that performs research on DNA does not “constructively reopen” the question of whether DNA is a double helix every time she publishes a paper. Instead, she assumes that premise is correct and then builds off of that premise. Likewise, regulators regularly build off of prior decisions when they make new decisions. It’s notable that the FDA’s decision on both the application and the citizen petition are adjudications, and the way adjudications ordinarily work is to treat prior decisions as settled and apply them to new facts. Indeed, if this case was about any issue other than abortion, this would be a completely obvious point. If the FDA decides (for instance) that Advil is so safe that you can now buy it over the counter, it is accepting as a premise, not “constructively reopening,” its prior decision that Advil is safe when prescribed by a doctor.
I have never heard of a case remotely supporting the plaintiffs’ position, so I was curious what case law the plaintiffs would cite. Here’s the money quote from the reply brief:
The D.C. Circuit has unequivocally applied the reopening doctrine analysis outside of rulemakings and to adjudications. See, e.g., Nat’l Biodiesel Bd., 843 F.3d at 1012–18 (applying reopening analysis to adjudication); Sendra Corp., 111 F.3d at 166–67 (same). Although the FDA’s dilatory citizen petition process historically has deterred challenges to drug approvals, Plaintiffs are unaware of any case in which a court held that the reopening doctrine is inapplicable to adjudications, let alone inapplicable to drug approvals. And for good reason—revising a prior adjudication involves a literal reopening of that prior action. In fact, a supplemental new drug application necessarily reopens a prior approval because the FDA relies on previous safety determinations and new information to make the requested changes.
Let’s take a look at the two cases that the plaintiffs cite— National Biodiesel Board and Sendra Corp.—in support of their “constructive reopening” argument and see whether they support the plaintiffs’ position.
Here’s what National Biodiesel Board says:
NBB next argues that its challenge is timely because EPA "reopened" the Rule when it approved the CARBIO proposal. The reopener doctrine allows an otherwise untimely challenge to proceed "where an agency has — either explicitly or implicitly — undertaken to `reexamine its former choice.'" National Mining Association v. Department of the Interior, 70 F.3d 1345, 1351 (D.C. Cir. 1995) (quoting Public Citizen v. Nuclear Regulatory Commission, 901 F.2d 147, 151 (D.C. Cir. 1990)). The CARBIO proposal is, the argument goes, a "constructive" reopening of the Rule, which "occurs 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.'" National Resources Defense Council v. EPA, 571 F.3d 1245, 1266 (D.C. Cir. 2009) (per curiam) (quoting Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008)). We have described the magnitude of alteration required to invoke this doctrine as a "sea change," and have declined to apply it when "the basic regulatory scheme remains unchanged." Id. As the Rule expressly establishes that foreign producers may seek approval of an alternative tracking program, the CARBIO plan neither alters that regulatory framework nor works a change that NBB members could not have reasonably anticipated. To the extent NBB argues that the CARBIO proposal is out of line with the Rule, this is — yet again — a challenge to EPA's application of the Rule rather than to the Rule itself.
Here’s what Sendra Corp. says:
For formal agency adjudications, an agency order stating only that it is denying reconsideration is conclusive, so long as the agency has not altered its original decision. Courts will not, in other words, look behind the agency's formal disposition of the reconsideration request to see whether the agency "in fact" reopened its original decision (and thus rendered a new final order). Id. There is a corollary to this rule. Only "when the agency has clearly stated or otherwise demonstrated," that it has reopened the proceeding will the resulting agency decision be considered a new final order subject to judicial review under the usual standards. Morris v. Sullivan, 897 F.2d 553, 558 (D.C.Cir.1990); see Cappadora v. Celebrezze, 356 F.2d 1, 4-5 (2d Cir.1966) (Friendly, J.). These principles of administrative law have no less force in informal adjudications. In both formal and informal adjudications, the agency must accompany its denial "of a written application, petition, or other request of an interested person" with "a brief statement of the grounds for denial," except when the denial is "self-explanatory." …Here, the Bureau's 1993 one-page letter to Sendra did not expressly say that it had reopened the matter and we detect nothing in the letter to indicate that it had done so.
Neither of these decisions offer the slightest support to the plaintiffs’ theory that the “constructive reopening” doctrine applies.
The plaintiffs do cite one case that applied the “constructive reopening” doctrine: Sierra Club v. EPA, 551 F.3d 1019, 1024 (D.C. Cir. 2008). That case involved a completely different theory of constructive reopening. The D.C. Circuit held that “from the perspective of environmental petitioners' interests and allocation of resources,” the prior rule wasn’t “worth challenging” because it had little effect, but the revised rule “changed the calculus” by increasing the prior rule’s significance.
This reasoning clearly doesn’t apply here because the plaintiffs did think the prior decision was worth challenging. They actually challenged it! They filed a citizen petition! They just didn’t file their lawsuit challenging the petition’s denial within the statute of limitations. Also, the whole premise of the plaintiffs’ lawsuit is that the 2000 decision exposes pregnant women to extreme risks. Why wouldn’t that be “worth challenging”?
There isn’t a single administrative law case ever that is even in the ballpark of supporting plaintiffs’ claims.
The plaintiffs haven’t exhausted their claims
The plaintiffs’ claims have yet another, clearly fatal defect: they haven’t exhausted their claims, even though they are explicitly required to do so as a prerequisite to judicial review.
An FDA regulation, 21 C.F.R. § 10.45(b), says: “A request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a [citizen petition] … before any legal action is filed in a court complaining of the action or failure to act.”
This means that the plaintiffs had to submit a “request that the Commission take or refrain from taking any form of administrative action” to the FDA before coming to court. They didn’t. Well they did, they filed a citizen petition challenging the 2000 decision, but the statute of limitations on challenging the resultant decision has expired. The citizen petition at issue in this case—the 2019 petition—doesn’t contain any request that the FDA withdraw approval of mifepristone. Thus, the plaintiffs can’t come to court seeking withdrawal of FDA approval of mifepristone.
How do the plaintiffs deal with this problem? The plaintiffs first say that the Administrative Procedure Act, on its own, doesn’t require exhaustion. But the FDA isn’t saying that exhaustion is required by the Administrative Procedure Act; it’s saying that exhaustion is required by the specific rule that requires exhaustion. The plaintiffs don’t suggest that the rule is invalid. So exhaustion is required.
The plaintiffs then say that exhaustion would have been “futile,” on the following basis: “it would have … been futile for Plaintiffs to include a challenge to the 2000 Approval in their 2019 Citizen Petition because the 2016 Petition Denial made ‘clear that the claim will be rejected.’”
Of course, the same thing could be said in literally every case: filing a citizen petition challenging a decision would be “futile” because the decision already exists, so no citizen petition is necessary. So much for exhaustion!
Also, don’t forget that the 2016 petition denial didn’t actually reconsider the merits of the 2000 approval—that’s why the plaintiffs have to say that the FDA “constructively reopened” that decision. So the plaintiffs are saying that the 2016 petition denial so clearly rejected their arguments that it would have been futile to raise them in a petition, even though the 2016 petition denial was completely silent on this topic and instead decided the issue only “constructively.”
The plaintiffs also seek to overturn other FDA actions (the approval of a generic version of mifepristone and the decision to relax the in-person dispensing requirement during COVID). The plaintiffs didn’t challenge these actions in the agency, so they can’t challenge those actions in court, end of case.
The plaintiffs finally contend that an old federal criminal law known as the Comstock Act prohibits the mail delivery of mifepristone. They complain that the FDA “did not include prohibitions on the upstream distribution of mifepristone from the manufacturer or importer to the abortionist” in its 2000 or 2016 decisions. Indeed, the plaintiffs complain that the FDA failed to “acknowledge and address” the Comstock Act.
That’s true, the FDA didn’t acknowledge and address the Comstock Act. That’s because the plaintiffs never asked it to! The plaintiffs never asked the FDA “to include prohibitions on the upstream distribution of mifepristone from the manufacturer or importer to the abortionist” in either of their citizen petitions. Therefore, under 21 C.F.R. § 10.45(b), that is the end of the road for the plaintiffs’ claim based on the Comstock Act.
The plaintiffs say that exhaustion was unnecessary because “the FDA’s actions violate the plain terms of these statutes.” No. First, asserting that a statute’s text is “plain” is not an exception to the exhaustion requirement. Second, since when does the FDA have to include provisions to facilitate enforcement of federal criminal laws on drug labels? Third, the statute isn’t as “plain” as the plaintiffs seem to think, given that the Office of Legal Counsel has recently concluded that the Comstock Act actually doesn’t bar the mailing of abortion medication.
Turning lemons into lemonade, the plaintiffs claim the latter point merely goes to show that exhaustion would have been futile: if plaintiffs had raised this argument years earlier, the FDA would have rejected it on the same ground as the Office of Legal Counsel, so they didn’t have to raise it! This theory also does not work. The plaintiffs have no idea what the FDA would have said or done years earlier. There’s no case suggesting exhaustion can be excused in this situation. I don’t understand how such a judicial opinion could be written.
No statute exists that the FDA could possibly have violated
OK, I understand, this procedural stuff is boring. Did the FDA actually break the law? The answer is no, not even close.
Just to clear away some brush, there is some back-and-forth in the briefs about whether FDA’s 2000 approval was inconsistent with so-called “Subpart H” regulations and whether the issue is moot in view of subsequent events in 2007 and 2011 that altered the regulatory framework. While I view the plaintiffs’ arguments on this issue as extremely weak, I don’t understand why we are even talking about these events that took place 23 years ago. The statute of limitations has expired on the challenge to the 2000 approval! The purpose of statutes of limitations is to avoid these discussions! Even accepting the plaintiffs’ premise that the 2016 decision “reopened” the prior decision, it’s still the 2016 decision, not the 2000 decision, that’s under review. If the FDA indeed silently reopened the issue and then silently re-decided that mifepristone was safe and effective, as the plaintiffs claim, it’s that silent decision—made under the regulatory framework in 2016—that’s under review by the court.
So what’s wrong with the 2016 decision? The plaintiffs claim that “the FDA violated the requirements of the FDCA.” But their statutory argument is … unconventional.
It is common for plaintiffs to bring administrative law claims alleging that an agency’s action conflicts with a federal statute. In such cases, it is conventional for the plaintiff to identify the statute alleged to have been violated, and explain how the agency action violates the statute. To resolve such a challenge, the court then lines the agency action next to the statute, interprets the statute if necessary, and decides whether the two conflict. This is what the Supreme Court did in its significant administrative-law decisions from last term on the vaccine mandate, the eviction moratorium, and EPA’s Clean Power Plan, and this is what the Justices struggled to do in the recent oral arguments on student loans.
The plaintiffs do not employ that conventional strategy here.
The plaintiffs’ chief complaint about the 2016 approval is that the FDA relied on studies that do not precisely match the conditions of use under the approved label. For example, the FDA approved extending the gestational age to 70 days. In one of the studies on which the FDA relied, the doctor conducted an ultrasound to confirm gestational age, and then did an in-person clinical follow-up. However, the drug label doesn’t require an ultrasound or an in-person clinical follow-up. According to the plaintiffs, the “FDA’s approved labeling needed to be at least as protective as the studies on which the agency purportedly relied.”
However, the plaintiffs do not actually cite any statute that imposes this requirement. Their opening brief cites 21 U.S.C. § 355(d), the statute outlining the FDA’s permissible grounds for refusing a drug approval application. But Section 355(d) doesn’t support the plaintiffs’ case. As relevant here, Section 355(d) says the FDA may refuse an application if:
Evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.
The FDA is entitled to consider “the information submitted to him as part of the application and any other information.” “Any other information!” How can this possibly be read to restrict the FDA from considering clinical studies that don’t precisely match the conditions on the label?
The plaintiffs’ reply brief doesn’t respond to this argument. I still have no idea what the statutory argument is here. The plaintiffs just make broad statements that the FDA “violated the FDCA.”
The plaintiffs also say it was “arbitrary and capricious” to rely on studies that don’t precisely match the conditions on the label. This is even more wrong than the statutory argument. It should be completely reasonable and uncontroversial for the FDA to do this. Of course agencies should be allowed to draw inferences and assess safety in circumstances that are not identical to the circumstances in the study. If in a study, a bunch of patients have follow-up visits and they are all fine, it is reasonable for FDA to infer that follow-up visits aren’t needed in every case. This is how science works! Studies are conducted under controlled conditions, and then scientists draw inferences and make predictions about what will occur in circumstances that do not match the studies.
Of course, the FDA needs to conduct a reasoned analysis of the available evidence and make a determination based on substantial evidence that the drug will be safe. It did that here—the FDA exhaustively analyzed many studies and drew inferences from them that the drug would be safe. It was not “arbitrary” or “capricious” to review studies that did not precisely match the conditions on the label and draw inferences from them.
And of course, there is an extremely deferential standard of review here, the FDA is the expert agency and is allowed to make scientific assessments. But even ignoring the deferential standard and considering the matter de novo, everything the FDA did makes perfect sense.
Again, there is an irony in the plaintiffs’ position. As in the context of Article III standing, the plaintiffs’ position really flips the standard progressive/conservative axis. Conservative interest groups are usually the tip of the spear against overregulation. They hate ponderous agency processes, in which agencies grind through procedures for years before the public is allowed to obtain useful products. And if you told a conservative interest group that a court was going to ban a product on which thousands of people rely because some ideological plaintiff feels that an agency didn’t look at enough safety studies 23 years ago … 99% of the time, the conservative interest group would go bananas. Yet here, it’s the conservative interest group that seeks to use a court to impose its philosophical preferences in the interest of protecting the “health and safety of women and girls,” i.e., banning women and girls from making their own decisions about their own health and safety.
The plaintiffs’ lawsuit is extremely weak and deserves to lose. I believe it will.
Thanks for reading this far! The next post is TBA, but if anyone has any suggestions or thoughts on subjects, I’d love to hear from you.
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