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We have been following – and commenting about − the unprecedented attacks on the FDA’s authority to approve drugs (and by extension all the products the agency regulates) in the Alliance for Hippocratic Medicine v. FDA litigation pretty much since the first bizarre district court rulings about a year ago in Alliance for Hippocratic Medicine v. FDA, 668 F. Supp.3d 507 (N.D. Tex. 2023), aff’d in part & vacated in part, 78 F.4th 210 (5th Cir. 2023), cert. granted in part and denied in part, 144 S. Ct. 537 (2023) (hereafter “AHM I” and AHM II”).

We normally try to keep our political views to ourselves on the Blog, but regardless of the AHM litigation’s impact on reproductive freedom, it poses a frontal attack on the FDA’s authority to approve drugs.  We pointed out here how the suit rested on laughably relaxed standing:  first that the anti-choice physician plaintiffs “would have to provide emergency care” for some number of women because of “unsuccessful chemical abortions,” rather than patients they preferred; second the claimed “stress to physicians from treating these women”; and even more broadly their “choice between performing their jobs and abiding by their consciences.”  We discussed the impact of judicial disrespect for the FDA’s scientific expertise and judgment here, examining the brief that the FDA filed in the Fifth Circuit.  When the Fifth Circuit likewise (although not quite as blatantly) ignored the FDA’s evidence-based decision-making, we posted once again.  We reiterated that the corrosive effect that the ludicrously low standing threshold in AHM II would affect the finality of FDA decisions across the board:

[F]or what we do, the most disturbing aspect is the extraordinarily low bar it sets for “standing” to challenge the validity of FDA actions.  If that bar is not re-raised, any medical crank in the country can try to overturn FDA product approvals. Just think about how antivax nuts could attempt to attack COVID-19 (or any other) vaccine if the “substantial risk” of “future injury,” necessary for standing to file suit amounts to only a ”fairly likely” possibility that “one of them” might suffer one of [their] purported “injuries.”

(Citations omitted).  This standard would permit similar plaintiff-side attacks on FDA approval of regulated products in product liability litigation under the limbo-low bar set in AHM II.

We turned to the substance of AHM II’s non-deferential standard of review in our next post on the litigation, discussing an article that analyzed in depth how:

None of those decisions acknowledged any of the Supreme Court opinions addressing the proper way FDA safety decisions are to be reviewed and respected[, . . .] how the Fifth Circuit failed to consider the controlling Supreme Court cases; failed to refute (or even acknowledge) the FDA’s analysis of the relevant scientific and medical data; and overturned the decisions FDA made in 2016 and 2021, while ignoring the new January 2023 REMS which now governs use of the drug.

Our most recent post underscored the perils we had addressed previously of judicial disregard for the FDA’s thorough review of relevant scientific data – pointing out that two of the judicially chosen articles that formed the district court’s de novo scientific rationale were retracted by the medical journal that published them for:  (1) undisclosed conflicts of interest – including the authors’ ties to one of the plaintiffs in that very litigation; and (2) “fundamental problems” with “study design and methodology,” “unjustified or incorrect factual assumptions,” “material errors” of data analysis, “misleading presentations of the data,” and “lack of scientific rigor,” as determined by independent post-publication review after the aforesaid hidden conflicts had corrupted the initial peer review process.

The Supreme Court recently heard oral argument on the merits in AHM  That argument was covered intensely elsewhere, and the consensus is that the FDA’s approval of mifepristone will prevail – probably for the standing reasons we mentioned previously.  That means that the Court will probably not reach the merits, including the arbitrary and capricious standard.  Here’s a link to the oral argument transcript.  We frankly don’t have much to add to the already voluminous commentary.

We do have a couple of comments about something, peripheral to the pending appeal, that came up during the oral argument – possible future use of the so-called “Comstock Act,” now found at 18 U.S.C. §1462-63 (formerly 18 U.S.C. §334).  Two of the farthest right Justices “repeatedly invoked” this 19th Century relic (passed in 1873, more than a half-century before the FDCA), as a possible basis for a future attack on the availability of mifepristone.

Our two comments are:

Flood v. Kuhn, 407 U.S. 258 (1972), a case we’ve cited only once before in the Blog’s 16-year run.

POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), which we discussed here and here.

In Flood, an antitrust case the Supreme Court considered a then-50-year-old decision, Federal Baseball Club v. National League, 259 U.S. 200 (1922), that had carved an extra-textual antitrust exception for major-league baseball, on the ground that MLB was not “commerce.”  Id. at 269-70 (discussing 1922 opinion).  That decision had been followed in 1953 per curiam affirmance (Toolson) also involving baseball, but otherwise distinguished.  Id. at 273-74.  By the time Flood came along, the concept that baseball was not commerce had lost all factual plausibility.  Flood nonetheless held that longstanding congressional inaction in the face of repeated intervening events justified the continuation of baseball’s exemption from the otherwise broad sweep of the express terms of the relevant antitrust statute.

We continue to be loath, 50 years after Federal Baseball and almost two decades after Toolson, to overturn those cases judicially when Congress, by its positive inaction, has allowed those decisions to stand for so long.

Flood, 407 U.S. at 283-84.  The discrepancy between what the antitrust law facially prohibited what judicial and administrative enforcement had nonetheless allowed, and the resultant societal expectations, was sufficiently long-standing – fifty years – that it was up to Congress, not the courts, to end it.

If there is any inconsistency or illogic in all this, it is an inconsistency and illogic of long standing that is to be remedied by the Congress and not by this Court.  If we were to act otherwise, we would be withdrawing from the conclusion as to congressional intent made in Toolson and from the concerns as to retrospectivity therein expressed.  Under these circumstances, there is merit in consistency even though some might claim that beneath that consistency is a layer of inconsistency.

Id. at 284.

Although the analogy with the Comstock Act is not perfect, since the ongoing intervening actions have been the FDA’s administrative actions rather than prior judicial precedent, we think the FDA’s repeated approval of both contraceptives and abortifacients, notwithstanding the broad and unenforced terms of the Comstock Act is, if anything, a fortiori to the baseball antitrust exemption.  The same “retrospectivity” concerns apply to the FDCA – the Comstock Act simply hasn’t applied to FDA-regulated products.

The 1873 Comstock Act broadly prohibited “any drug or medicine, or any article whatever, for the prevention of conception, or for causing unlawful abortion, or shall advertise the same for sale.”  17 Stat. §598.  That was long before the FDA even existed.  Well over sixty years passed until 1938, when the FDCA was enacted, creating the current federal scheme for regulating “drugs” and “medicines” – with no reference to the Comstock Act’s prohibitions.  In May, 1960, the FDA approved its first contraceptive, the oral contraceptive Enovid, and within two years, it had been prescribed well over a million times.  Nobody raised the Comstock Act in opposition.  Many more FDA approvals of different types of contraceptives followed – over 250 by one count.  Never was the Comstock Act raised in opposition, either administratively or in the courts.

To the contrary, in Bolger v. Youngs Drug Product Corp., 463 U.S. 60, 70 (1983), involving “unsolicited contraceptive advertisements,” the government (although bearing the burden of proof) declined altogether to rely on the Comstock Act.  Id. at 70-71 (“The Government does not purport to rely on justifications for the statute offered during the 19th Century” given “the insufficiency of the original motivation”).  See also Consumers Union of United States v. Walker, 145 F.2d 33, 34-35 (D.C. Cir. 1944) (rejecting, in a case involving contraceptive information, an argument that the Comstock Act “must be read and applied, literally, regardless of consequences,” since that would lead to “absurdity or injustice”).

Nor has Congress sought to encourage enforcement of the Comstock Act against FDA-approved products.  Instead, in 1971, it deleted that statute’s contraceptive bar altogether.  PL 91-662, 84 Stat. 1973.  The same was true when the FDA began approving abortifacients.  Nobody, neither public nor private litigants nor Congress, sought to resurrect the Comstock Act in any area governed by the FDCA before the first AHM opinion issued in April of 2023.

That includes our civil adversaries.  As we’ve pointed out several times before, over the years, the plaintiff’s bar has been one of the most consistently anti-choice litigation forces, claiming that practically every form of contraceptive the FDA has ever approved is “defective” or “unreasonably dangerous.”  But never once has any product liability plaintiff raised the Comstock Act opposition to preemption or to any other of our clients’ FDCA-based defenses.  We ran several case searches, for both “Comstock,” and its evolving statutory citations, appearing anywhere in the same opinion as “FDA,” FDCA, “drug,” and “medicine,” and found nothing since the FDCA’s 1938 enactment.  Indeed, the last decision we could find concerning a Comstock Act prosecution that actually involved what would now be considered a drug or medical device (as opposed to literature) is United States v. One Package, 86 F.2d 737 (2d Cir. 1936) (contraceptive device).

Thus, when the FDCA was passed in 1938 it ousted the Comstock Act from the FDCA’s regulatory bailiwick.  Since then, it has been the FDA’s role (not the Post Office’s) − implemented by scores of unchallenged product approvals over a sixty-plus year period − to regulate contraceptives and/or abortifacient drugs and medical devices without regard to the Comstock Act.  Over the same period, no court or other federal agency has expressed any contrary views, nor has Congress in any way acted to resuscitate the 1873 statute.  Thus, the same basic reasons exist, as they did in Flood, for an “FDA exception” (if any is in fact needed) to the Comstock Act:  (1) consistent regulatory (as opposed to judicial) practice; (2) extensive passage of time, here over 85 years since the FDCA’s 1938 enactment, and over 60 years since the FDA began approving products that the Comstock Act purportedly banned; (3) implicit Congressional acquiescence, as shown by prolonged inaction, both before and after Roe v. Wade; and (4) “concerns as to retrospectivity.”  407 U.S. at 284-85.  Rather, “the remedy, if any is indicated, is for congressional, and not judicial, action.”  Id. at 285.  Unless and until Congress provides otherwise, the FDCA controls the availability of drugs and medical devices that affect reproductive choice – not the cold, long-dead hand of Anthony Comstock.

The second comment involves POM Wonderful, 573 U.S. 102, which undertook to “to reconcile or harmonize” two overlapping federal statutes, one of which was the FDCA, and the other the Lanham Act, 15 U.S.C. § 1125(a)(1), a generalized consumer protection statute.  Id. at 112.  The Court found that “the Lanham Act and the FDCA have coexisted since the passage of the Lanham Act in 1946.”  573 U.S. at 113.  Thus, it had no reason to consider whether one statute worked an “implied repeal” of the other because there was no “genuinely irreconcilable conflict.”  Id. at 112-13.  Instead, the FDCA and the Lanham Act “complemented” each other and created “synergies among multiple methods of regulation.”  Id. at 115-16.  These comments were specific to food, because:

Unlike other types of labels regulated by the FDA, such as drug labels, . . . the FDA does not preapprove food and beverage labels under its regulations and instead relies on enforcement actions, warning letters, and other measures. Because the FDA acknowledges that it does not necessarily pursue enforcement measures regarding all objectionable labels, . . . then commercial interests − and indirectly the public at large − could be left with less effective protection in the food and beverage labeling realm than in many other, less regulated industries.  It is unlikely that Congress intended the FDCA’s protection of health and safety to result in less policing of misleading food and beverage labels than in competitive markets for other products.

Id. at 116 (citations omitted).

The defendant’s arguments about the FDCA’s “greater specificity” also failed because that “matter[ed] only if the Lanham Act and the FDCA cannot be implemented in full at the same time.”  Id. at 118.  The same lack of conflict also defeated the government’s (representing the FDA) intermediate argument that certain Lanham Act claims in the case survived while others could not, relying on the Geier v. American Honda Motor Co., 529 U.S. 861 (2000), airbag decision.  Unlike the “direct” conflict in Geier, those two federal statues could co-exist.

[Geier] concluded that the action was barred because it directly conflicted with the [federal] agency’s policy choice. . . .  Here, by contrast, the FDA has not made a policy judgment that is inconsistent with [this] Lanham Act suit.  This is not a case where a lawsuit is undermining an agency judgment . . . .  The Government asks the Court to preclude private parties from availing themselves of a well-established federal remedy because an agency enacted regulations that touch on similar subject matter. . . .  [That] is a bridge too far.

POM, 572 U.S. at 120 (Geier citations omitted) (emphasis added).

Comstock Act litigation seeking to prohibit the marketing and sale of products for their FDA-approved “intended uses” under the terms of FDA-imposed REMS (such as the one mentioned in our earlier quote specifically allowing telemedicine prescription for mifepristone) would present the type of direct conflict alluded to, but not found, in POM.  The FDA has affirmatively said “yes” through product-specific pre-approval to drug availability that Comstock Act litigants would seek to prohibit.  That’s as direct a conflict as is imaginable.  Nor is there any “well-established federal remedy” afforded by the Comstock Act, which, as discussed, the Post Office has not applied to any drug or medical device since the FDCA was enacted in 1938.  Indeed, both the yes/no conflict inherent in any application of the Comstock to an FDA-regulated product, and the fact that no Comstock Act attack against an FDA-approved product has ever been attempted, let alone succeeded, suggest that an “implied repeal” of the sort mentioned in POM, but not addressed, most closely approximates the FDCA’s actual effect on the Comstock Act.

Finally, post-POM cases involving Lanham Act actions against marketers of FDA-regulated products have followed the distinction discussed above between complementary and conflicting claims.  We’ve written several posts since POM was decided in 2014 examining this dividing line – focusing on Lanham Act claims that attacked the FDA’s approval or classification of particular products.  We will not repeat those observations here, except to a say that purported Lanham Act allegations that directly contradict an FDA regulatory decision continue to be precluded.  Under the kind of federal statutory “reconciliation” that the Supreme Court effectuated in POM Wonderful, the fact of an in-effect FDA product approval, with whatever requirements that may entail, should preclude the same product from being banned for an FDA-approved intended use under the Comstock Act.