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Exasperated But Not Exhausted: Unlocking the Trap Set by the Exhaustion Doctrine on the FDA’s REMS Petitioners

Posted by on Saturday, April 20, 2024 in Notes, Volume 77, Volume 77, Number 3.

Michael Krupka | 77 Vand. L. Rev. 937

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not yet exhausted the FDA’s mandatory administrative remedy. In accepting this argument, courts across the country have misapplied the exhaustion doctrine in FDA cases, depriving potential petitioners of judicial review and leaving the FDA’s original REMS decisions without any oversight. All the while, societal costs of unaccountable drug decisions continue to climb.

This Note examines the dilemma of REMS petitioners, the “exhaustion trap,” wherein petitioners cannot seek legal remedy until the FDA allows them to exhaust their administrative remedy. Through original empirical analysis, this Note finds the FDA responds to fewer than one-third of REMS petitions before its own 180-day deadline, with petitioners languishing for an average of 937.6 days (2.56 years) before the FDA lets them exhaust this administrative remedy. So, petitioners frequently remain trapped and exasperated, while their remedies—by no fault of their own—remain unexhausted.

This exhaustion trap is superable, however, and this Note proposes three potential escape routes. First, the plain language of the APA’s statutory provision codifying the exhaustion doctrine—5 U.S.C. § 704, as interpreted by the Supreme Court in the landmark case Darby v. Cisneros—prohibits the exhaustion trap. Second, this Note proposes an amendment to the Food, Drug, and Cosmetic Act that would waive the FDA’s exhaustion requirement when the FDA disregards its own deadline of 180 days. Finally, this Note suggest that courts should waive the FDA’s exhaustion requirement more readily in these cases. Given the stakes for public health, the American people deserve remedies that are actually exhaustible.

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Michael Krupka