the U.S. Food and Drug Administration’s growing - and in some respects peculiar - reliance on guidance documents. Although only offered as a case study, it poses (without necessarily answering) a number of broader questions that may interest administrative law scholars. For instance, when Congress demanded that the FDA use an abbreviated notice-and-comment process to formulate major guidance documents, did this reflect a throwback to informal legislative rulemaking as originally conceived (and will this new variant also become ossified over time)? Along those lines, if a final nonbinding guidance is no more authoritative than a draft version of that same guidance, then what motivates agencies to abide by this hybridized procedure? Separately, when OMB treats a guidance document as likely to have a significant impact on the economy, might such a finding influence courts when agencies interpose ripeness objections in response to challenges to these purportedly nonlegislative rules? In addition, when Congress specifically has required (sometimes with strict deadlines) or invited an agency to issue guidance, should courts accord interpretations of that statutory provision greater deference than normally granted announcements lacking the force of law? Conversely, in areas where Congress has not specifically called for guidance-making, what does one make of the fact that large and important swaths of the FDA’s activities (e.g., genetically modified foods and prescription drug advertising) depend almost entirely on technically nonbinding announcements, or the fact that a number of the agency’s legislative rules governing other subjects incorporate by reference guidance that it has (or will in the future) issue? Finally, in what respect do threats and offers (in enforcement and licensing contexts) allow agencies to secure “voluntary” adherence to nonbinding guidance (and is this at least preferable to tolerating the use of such informal means of leverage to pursue entirely unannounced policies)?
23 September 2013
'Governance by the Backdoor: Administrative Law(lessness?) at the FDA' by Lars Noah in (2014) 93(1) Nebraska Law Review discusses