FDA and the Adaptation of Regulatory Models

Abstract:     
This article considers lessons from the history of the agency's adaptation of the regulatory statute to new developments. Some of these developments have been led by the agency and some by the courts. Notable measures include the recognition of a de minimis risk level for carcinogens in many products, the regulatory acceptance of accelerated approval for drugs to treat life-threatening conditions, and the policy of regulating genetically-modified foods within the existing regulatory framework. On the other hand the Supreme Court rejected the FDA's effort to extend its regulatory jurisdiction to cover tobacco. In recent years, the constitutional protection for commercial speech protections have made it necessary for the agency to adapt its traditional policies to the approach of permitting disclosures as an alternative to mandatory regulation. Agencies, including FDA, that find themselves involved in implementing the prescription drug benefits to seniors need to consider their role in adapting the law to meet the new challenge.

Number of Pages in PDF File: 10

Keywords: Administrative law, rulemaking, statutory interpretation, Delaney Clause, FDA, Food and Drug Administration

Accepted Paper Series