U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, et al., Brief of Amicus Curiae Mountain States Legal Foundation in Support of Respondents

Abstract

Amicus takes no position on the underlying merits of this case but supports Respondents because of a shared concern over the harm imposed by the Food and Drug Administration’s unlawful administrative-exhaustion regulation, which purports to prohibit a party from challenging “any” otherwise-final “administrative action” in court unless the party has first filed—and the FDA has denied—a “citizen petition” asking the FDA Commissioner himself to rescind or amend the challenged action that the FDA has already taken.

There is no hard requirement for when the FDA must resolve a citizen petition. And while that petition remains pending, the underlying FDA action goes into effect unless the FDA agrees to stay its own hand, which requires the challenger to make an extraordinary showing.

As a result, the FDA claims the power to take otherwise-final agency action that becomes effective immediately, while also avoiding judicial review of that action until the FDA itself decides to reject the citizen petition, which could be years or even decades later. In this case, for example, Respondents filed a citizen petition in 2002 that challenged the FDA’s otherwise-final action of approving mifepristone for use in 2000. Because the FDA sat on the petition and did not deny it until 2016, Respondents had to wait well over a decade to seek judicial review of that 2000 approval.

Amicus submits this brief to explain that, as applied to “agency action otherwise final,” the FDA’s exhaustion regulation is unlawful under the Administrative Procedure Act. Congress anticipated that agencies might try to use procedural roadblocks to delay—perhaps for years or even decades—judicial review of otherwise-final action, and Section 704 responds with its own broad language prohibiting an agency from imposing such hurdles, regardless of the name or form they may take.

This brief addresses only exhaustion of administrative remedies, not issue exhaustion. The FDA’s exhaustion regulation purports to require an additional layer of agency review before judicial review may be obtained and therefore directly implicates exhaustion of administrative remedies (i.e., the requirement to “proceed[] through each step of the [agency’s] administrative review scheme and receive[] a ‘final decision’ before seeking judicial review”). Section 704 of the APA likewise “codified the doctrine of exhaustion of administrative remedies.” But exhaustion of administrative remedies “should not be confused” with “issue exhaustion” (i.e., “giv[ing] the agency an opportunity to address an issue before seeking judicial review of that question”).

Exhaustion of lawful administrative remedies is required under the APA, which is why it is important that agencies not impose procedural layers the APA bars.

Keywords: Separation of Powers, Judicial Review, FDA, Administrative Law, Final Agency Action, Administrative Exhaustion, Regulation

JEL Classification: K23, H1, H11, I18