## Facts

- Vermont faced substantially higher prescription drug prices domestically than in nearby Canada, contributing to increased personal importation by state residents.
- Vermont sought to facilitate safer, more structured access to lower-cost Canadian prescription drugs and related information initiatives.
- Vermont submitted a citizen petition to the FDA requesting federal action or clarification that would permit the state to proceed with its importation-related program.
- The FDA denied the citizen petition, citing statutory limits, safety risks, and enforcement and resource constraints related to large-scale importation.
- Vermont and its Agency of Administration sued federal officials, challenging the denial under the Administrative Procedure Act (APA).

## Issues

1. Whether the FDA’s denial of Vermont’s citizen petition concerning prescription drug importation-related initiatives was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law under 5 U.S.C. § 706(2)(A).

## Decision

- The court upheld the FDA’s denial of the citizen petition.
- The court granted judgment for the federal defendants and denied Vermont’s request to set aside the agency action.
- The court held that the denial was not arbitrary or capricious under the APA because the agency reasonably explained its decision based on safety, enforcement feasibility, and statutory constraints.

## Legal Principles

- Under 5 U.S.C. § 706(2)(A), a court must set aside agency action only if it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
- Arbitrary-and-capricious review is narrow; a court may not substitute its judgment for the agency’s and asks whether the agency considered relevant factors and gave a rational explanation connecting facts to its choice.
- Courts generally defer to the FDA’s technical and policy judgments in drug safety and enforcement, so long as the agency’s reasoning is adequately explained.
- An agency need not address every argument in detail; it must provide a sufficient explanation showing the basis for its decision within the governing statutory framework.
- Economic and state policy concerns, without a showing of legal error under the APA, do not justify judicially compelling a different regulatory outcome.

## Conclusion

The court concluded that the FDA permissibly denied Vermont’s citizen petition because the agency reasonably relied on drug-safety risks, enforcement limits, and the federal statutory scheme governing importation, and Vermont failed to show the denial was unlawful under the APA.


Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005)