Prevor v. Food and Drug Administration
- Case Date: 1/19/2012
- Project Name: Health Care Project
On September 25, 2012, a federal district court issued a decision that effectively prevents the Food and Administration (FDA) from implementing new product classification rules that could cause numerous medical products previously classified as devices to be reclassified as drugs. The decision was a victory for WLF, which filed a brief urging the court to block FDA efforts to classify a new product as a “drug,” apparently on the basis of FDA’s new classification rules. WLF argued that the new rules conflict with the federal statute that defines what constitutes a “device.” The court agreed with WLF that the decision to classify the product as a “drug” was “arbitrary and capricious,” and it remanded the case back to the agency. In light of its decision, the court did not need to reach an additional argument raised by WLF: that the new rules violate the Administrative Procedure Act because all major changes in FDA policy require use of formal notice-and-comment rulemaking procedures.
|Victory. Monitor for appeal.|
More Information and Downloads:
1/19/2012: Download the Brief
Litigation Update: Court Overturns FDA Efforts To Modify Drug/Device Classifications