Cornell Law Review Volume 93 Issue 5

Losing Deference in the FDA’s Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise

The Food and Drug Administration (FDA), created by the Federal Food and Drugs Act of 1906, recently entered its second century. With this new century comes new challenges, including the ever-increasing risk that the Agency will no longer enjoy the deference historically given to its policy decisions. The judicial deference given to the Agency is usually attributed to the FDA’s century-long legacy of scientific expertise. However, in recent years, the news media has disdained the Bush Administration’s political manipulation of the FDA and has questioned the Agency’s scientific integrity. This criticism of the Administration’s political manipulations of the FDA (for the benefit of conservative political constituencies) may diminish the willingness of federal judges to defer to our nation’s most distinguished regulatory Agency. And if the FDA loses its legacy of deference, its ability to regulate efficiently will diminish significantly.

This Article discusses milestones in the FDA’s legacy, explores the evolution of deference to the FDA (and its empowerment as a regulator during its first century), and notes the indications of diminished scientific independence at the hands of Bush Administration appointees serving powerful constituencies. This Article also discusses the growing attention to the politics underlying FDA decisions in recent years, and how that attention may diminish the FDA’s carefully built aura of scientific integrity. Further, this Article analyzes how public recognition of the Bush Administration’s political control over the FDA may erode federal judges’ views of the Agency, making them less receptive to deference arguments. Finally, this Article explores the already-present consequences of a politicized FDA: by examining antiabortion groups’ influence over the approval process for the drug “Plan B” and also the political motivations behind the FDA’s recent policy shift in favor of preemption, this Article concludes that political direction of the FDA—both overt and covert—has diminished the likelihood of future judicial deference to the Agency.


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