(Un)Safe and (In)Effective: Preemption, Deference, the FDA, and the Opioid Crisis

The Food and Drug Administration (“FDA”) is tasked with keeping prescription drugs safe and effective for the American people. The FDA has long enjoyed deference in its decision-making because of the ambiguity in its organic statute, the Federal Food, Drug, and Cosmetic Act (“FDCA”). Gaining FDA approval for prescription drugs, however, is not a rubber stamp that frees a drug manufacturer from liability. Prescription drug manufacturers, such as opioid manufacturers, have been unsuccessful in convincing courts to use the concept of federal preemption and deference—specifically FDA approval and therefore judicial deference to that approval—to shield them from liability from state law claims against the distribution of these drugs. With the fall of Chevron deference in June 2024, it is unclear if the FDA will still enjoy the deference it has received, potentially leading to the promulgation of litigation against the FDA for (un)safe and (in)effective drugs. This Note examines the evolution of litigation against prescription drug manufacturers, specifically opioid manufacturers, by analyzing the difficult-to-meet standard of federal preemption under the FDCA. It then examines the history of deference to the FDA under Chevron by using the FDA approval and regulation of opioids as a case study. Lastly, it predicts how the overruling of Chevron by Loper Bright Enterprises v. Raimondo will impact the prescription drug landscape—ranging from circuit splits, to changes in the FDA structure, to even a floodgate of ligation against the FDA itself.

View Full PDF