Marketing Authorization at the FDA: Paradigms and Alternatives

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first level, the framework divides the FDA’s marketing authorization programs into three components: pathways, designations, and means of access before marketing authorization. At the second level, the framework distinguishes between two types of pathways, three types of designations, and four means of access before marketing authorization. This framework gives a coherent intellectual structure to a sprawling set of regulatory programs that are otherwise difficult to analyze. Based on this framework, the Article makes several analytical contributions specific to food and drug regulation.The Article’s final contribution highlights a newly identified phenomenon, interchangeable-part lawmaking (IPL), that should be of broader interest. IPL takes place when a government entity takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. It is strikingly visible in the statutes administered by the FDA, but IPL likely exists in statutes more generally. IPL has substantial implications for statutory interpretation, as well as for numerous strands of academic literature