Note: This case involves the drug mifepristone, which is an abortifacient drug that is used to terminate a woman’s pregnancy. Mountain States Legal Foundation makes clear in its amicus brief to the Supreme Court that we are addressing only the administrative-law issues presented in the case. Specifically, the brief asks the Court to disapprove of the indefinite delay by the FDA and explains how such delays affect our work in our energy and natural resources practice area. **
Administrative review processes can take years and, in some cases, even decades. In this case, one Executive Branch agency’s administrative review took nearly 14 years. All the while, the rule being challenged was “in effect” against the challengers. Mountain States itself knows cases like this all too well, as we often confront delays and the duty to “exhaust” lengthy administrative processes before filing our lawsuits. Two good examples are our Solenex and Rayco cases, where we won at the district courts after the Department of the Interior imposed years and years of delay.
Here, the U.S. Food and Drug Administration forced the party challenging its drug approval to submit a challenge to the agency for further review before being able to seek a review of the drug approval by a federal court. Under established precedent, the FDA was generally allowed to do that under a federal law called the Administrative Procedure Act (APA). But the FDA is supposed to pay a price under the APA for that choice: it can force a challenger to wait for its internal review only if the agency suspends its own action while the review is pending. Yet that didn’t happen here, because the FDA’s internal-appeal processes don’t comply with the APA. Instead, the FDA held the drug approval in place while it took “13 years, 7 months, and 9 days” to review its own action. After all that time, the agency of course denied the challenge.
Notably, since the FDA went ahead with its agency action during the pendency of the challenge, there was no incentive for the agency to have a quick review process. The opposite happened: delay benefitted the FDA by stalling the challenge to its drug approval.
As Mountain States has experienced in our cases, it’s not just the FDA that has internal rules that don’t comply with the APA. In several other contexts, a challenger to agency action is at the mercy of agency review, with no pathway to federal courts until the review process is finished; and yet our clients are still charged with abiding by the challenged agency action.
The type of “regulatory exhaustion trap” that occurred in this case happens all the time, especially out here in the West. And we want to let the Court know these unlawful review processes do not only arise in the context of challenges to the FDA. For instance, when our clients challenge the actions of the Department of the Interior, regulators tell our clients that they must first take any challenge to the Department’s Board of Land Appeals. But it’s a trap! This process can take years. And while Mountain States will never stop fighting on behalf of our clients, we recognize that the appeals process is an unlawful stall tactic used by the Department to discourage and delay any challenges to its actions.
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The point of our brief is to highlight how in the West, the Department of the Interior has weaponized its “review process”—in violation of the APA—to trap a challenger for years in red tape at its Board of Land Appeals, before ever getting access to a federal court, just as the FDA did to the challenge of its drug approval in this case.
Mountain States is advocating for a clear statement from the Supreme Court recognizing that the FDA’s internal rules conflict with federal law. Instead, challengers have a statutory right to avoid the “regulatory exhaustion trap,” and go straight to the federal courts. Agencies can’t overrule Congress in that regard.
All individuals and companies, including Mountain States’ clients, who want to challenge a federal regulatory action, need to have reasonable access to a federal court so they can present their challenges to an unbiased federal judge. They should be able to do so without waiting years or decades for a federal agency to decide that it was correct all along.
Mountain States hopes that the Supreme Court will issue an opinion that speaks to this issue, and even offers broad language about other Executive Branch agencies as well. We know that federal regulators will always seek to delay challenges to their actions, and we are trying to better arm ourselves to overcome those delays. This case presents an opportunity to do that.
What’s at Stake?
In our cases, we have seen regulators string out their reviews of their own actions for decades, while those actions harm our clients. All the while, these agencies keep their actions in place, despite the APA saying that they can’t. This type of delay “trap” by federal regulatory agencies contradicts federal law. This case provides the Supreme Court with the opportunity to give challengers a reasonable process in challenging regulatory actions. And we hope the Court will review our brief and comment on it when it issues an opinion.
Case Update 6/14/2024
Mountain States is disappointed to hear about the ruling handed down by the Supreme Court yesterday in the FDA v. Alliance for Hippocratic Medicine case. This was an opportunity for the Supreme Court to make a clear statement about how the internal review process of regulatory agencies is often contrary to the law. Instead of holding regulatory agencies accountable for their interminable internal review processes, which is in large part what led to this case in the first place, the Supreme Court ruled that the plaintiffs, Alliance for Hippocratic Medicine, did not have standing in the case. Agencies often use their internal review process as a regulatory exhaustion trap, something many of our clients experience, to delay challenges to their actions and keep their unjust regulations in place for a long time before they get corrected. While we are disappointed that the Court did not reach the “regulatory review” part of this case, we will continue to stand up for our clients and fight against unlawful and unreasonable regulatory practices.
