Photo of Lisa Baird

We have posted a few times (here, here, and here) about the Alliance for Hippocratic Medicine v. FDA/Alliance for Hippocratic Medicine v. Danco Labs., LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone, a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol.  (Mifepristone also is approved to treat hyperglycemia in patients with Cushing’s syndrome but, no surprise, that indication never seems to be a target.)

To date, the Alliance for Hippocratic Medicine (which our posts sometimes refer to as “AHM” and sometimes as “Hippo”), has found a receptive audience in federal court.  The Fifth Circuit overrode scientific and regulatory decisions made by the FDA about mifepristone, in particular its changes to mifepristone’s approved conditions of use in 2016 and its elimination of in-person dispensing requirement in 2021 (The district court also would have overturned the initial approval of mifepristone in 2020 as well, but the Fifth Circuit felt that regulatory decision was too old to challenge now.)

Like many hot-button lawsuits of late, these cases went first to the Northern District of Texas and then up to the Fifth Circuit.  How do these particular courts keep getting these particular types of matters?  It is no accident—thank single-judge divisions which allow litigants like AHM/Hippo to hand-pick politically-friendly judges, with the additional assurance of appellate review by the politically-friendly Fifth Circuit. 

The latest development in the AHM/Hippo litigation is that two cert petitions have been filed seeking Supreme Court review of the Fifth Circuit’s orders.  The cert petition in Food and Drug Administration v. Alliance for Hippocratic Medicine (case no. 23-235) presents the following issues:

  • Whether the Alliance for Hippocratic Medicine organization has Article III standing to challenge certain FDA actions with respect to mifepristone’s approved conditions of use;
  • Whether certain FDA regulatory actions regarding mifepristone were arbitrary and capricious; and
  • Whether the district court’s decision, effectively enjoining the FDA’s approval and subsequent regulatory actions regarding mifepristone, was proper.

And the cert petition in Danco Labs., LLC v. Alliance for Hippocratic Medicine (case no. 23-236) presents related issues:

  • Whether an organization like the Alliance for Hippocratic Medicine can demonstrate Article III standing by arguing that some unspecified member may be injured at some future time; and
  • Whether the Fifth Circuit erred in upholding the preliminary injunction based on an incomplete administrative record.

The responses by AHM/Hippo to the cert petitions are due November 9, 2023, and after that, the Supreme Court will decide whether it wants to take the cases and reach the merits of the issues.  In the meantime, as you might expect, numerous amicus briefs have been filed, mostly urging the Supreme Court to take the cases for review. 

Of particular interest to us today is the amicus brief in support of review filed by PhRMA, the Pharmaceutical Research and Manufacturers of America, which develops some of the issues we previously discussed.  As Bexis put it:

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products.  That’s why Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), is so important.  It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions.  It has generally been assumed that such plaintiffs, while free to seek an advisory opinion from the FDA, may not collaterally attack FDA decisions in other litigation.  E.g., Estee Lauder, Inc. v. FDA, 727 F. Supp. 1, 6 (D.D.C. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. Collagen Corp., 870 F. Supp. 885, 891 (N.D. Ind. 1994) (“an advisory opinion, rather than being the catalyst for preemption, allows an ‘interested person’ to determine whether a state requirement can safely be ignored”), aff’d, 67 F.3d 1268 (7th Cir. 1995), vacated on other grounds, 518 U.S. 1030 (1996).

Indeed, Bexis and his co-authors published an entire law review article discussing federal preemption and medical abortion. See Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Post-Dobbs Reproductive Freedom Frontier,” 78(2) Food & Drug L.J. 109 (2023).

PhRMA’s amicus brief supports review of the AHM/Hippo cases for a similar reason—because the entire industry’s willingness to invest in R&D for new drugs also “depends on the continuing validity of what the FDA does with respect to prescription medical products,” while the Fifth Circuit’s ruling threatens those interests (not to mention patient access to essential new medical treatments):

The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. Considering the rigorousness of this process and the due process interests of drug sponsors, Congress also mandated by statute a process for withdrawal or suspension of an FDA approval decision—a process the Fifth Circuit circumvented. But if every FDA drug approval decision—and subsequent supplemental drug approval decision—can be retroactively invalidated by a court based on extra-statutory, judicially created requirements, biopharmaceutical companies will likely invest less in the advancement of new and existing medicines that benefit patients.

PhRMA Amicus Brief, at 3-4.  Stated differently:

Biopharmaceutical companies invest substantial time and resources into research and development based on the reasonable expectation—grounded in the exclusive regulatory authority Congress has conferred on FDA—that absent exigent circumstances, once a New Drug Application (or Supplemental New Drug Application) is approved by FDA, it will be lawful and potentially profitable to market that product in accordance with the conditions of that approval for an extended period anywhere in the United States. Without that assurance, the incentive to innovate diminishes. The reason is simple. If every new or supplemental approval decision is subject to an appreciable risk of being upended by a court based on judicial assessments of studies, judicial reweighing of evidence, and judicially fashioned post hoc requirements, biopharmaceutical companies could have dramatically lower predictability regarding return on investment from an approved drug and thus decide to invest less in the advancement of medicines.

PhRMA Amicus Brief, at 19-20.

Although the question before the Supreme Court at the moment is only whether to take these appeals, the merits issues are deeply entwined with the cert-worthiness of cases.  From initial approval decisions, through supplemental changes, to risk mitigation decisions, FDA puts manufacturers through the wringer, resulting in an approval of only an average of 38 new drugs annually. See Congressional Budget Office, Research and Development in the Pharmaceutical Industry at 1 (Apr. 2021).  Thus, the PhRMA amicus explains that while the Fifth Circuit’s ruling was based on its criticisms of the FDA’s regulatory rigor, the FDA’s procedures are far from cavalier:

  • The new drug approval process starts with laboratory studies to test how a proposed medicine works and assess its safety. See 21 C.F.R. § 312.23(a)(8).
  • If the results are promising, the company submits an investigational New Drug Application to FDA, explaining those results and a clinical trial plan. See 21 U.S.C.§ 355(i)(2); 21 C.F.R. § 312.20(a)–(b).
  • After completing multiple rounds of clinical trials, the company can submit a New Drug Application, often 100,000 pages long.  See 21 C.F.R. § 312.21. The New Drug Application must include (among other things) “full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use.” 21 U.S.C. § 355(b)(1)(A).
  • Then, an FDA review team comprised of multidisciplinary experts diligently evaluates the studies submitted.  If the FDA concludes the drug is safe and effective for its proposed use and that “none” of the seven specified “grounds for denying approval” apply, then FDA can approve the drug for use. See 21 U.S.C. § 355(c)(1)(A), (d).
  • Post-approval, the company may submit supplemental applications seeking changes that, among other things, extend the drug approval to treat another disease or condition; expand the patient population that a drug is approved to treat; or approve a new dosing schedule that allows a drug to be taken less frequently. “Supplemental New Drug Applications” are generally subject to the same procedures and standards as the original New Drug Applications. See 21 U.S.C. § 355(b).
  • FDA also has authority over drug safety programs known as Risk Evaluation and Mitigation Strategies (“REMS”). See 21 U.S.C. § 355-1. REMS generally focus on risk mitigations that help “ensure the benefits of the drug outweigh the risks of the drug.” Id. § 355-1(g)(4)(B)(i).
  • Finally, FDA has exclusive authority to withdraw approval of a New Drug Application or a Supplemental New Drug Application—pursuant to specified procedures—if it finds that “experience,” “tests,” “scientific data,” or other “new evidence” show that the drug “is unsafe for use under the conditions” for which it was approved. 21 U.S.C. § 355(e).

See PhRMA Amicus Brief, at 6-9. 

FDA is itself one of the petitioners in these AHM/Hippo cases, and it was not amused by the Fifth Circuit’s interference with its regulatory decisions and its curtailment of its congressional mandate.  Fortunately, as PhRMA noted, key members of the Supreme Court previously have acknowledged the importance of judicial deference to FDA expertise:

“A court is ill-equipped to second-guess” FDA’s “scientific judgment” under the guise of the Administrative Procedure Act’s arbitrary-and-capricious standard. Cytori Therapeutics, Inc. v. FDA, 715 F.3d 922, 927 (D.C. Cir. 2013) (Kavanaugh, J.). Indeed, “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’” FDA v. Am. Coll. of Obstetricians & Gynecologists, 141 S. Ct. 578, 578–79 (2021) (Roberts, C.J., concurring in grant of application for stay).

PhRMA Amicus Brief, at 9.  If the Supreme Court ever gets to the merits, let’s hope they remember.