he regulatory state through the lens of evolving political economy, arguing that a significant reconstruction is now underway. The ongoing shift from an industrial mode of development to an informational one has created existential challenges for regulatory models and constructs developed in the context of the industrial economy. Contemporary contests over the substance of regulatory mandates and the shape of regulatory institutions are most usefully understood as moves within a larger struggle to chart a new direction for the regulatory state in the era of informational capitalism.
A regulatory state optimized for the information economy must develop rubrics for responding to three problems that have confounded existing regulatory regimes:
(1) platform power — the power to link facially separate markets and/or to constrain participation in markets by using technical protocols;
(2) infoglut — unmanageably voluminous, mediated information flows that create information overload; and
(3) systemic threat — nascent, probabilistically-defined harm to be realized at some point in the future.
Additionally, it must develop institutions capable of exercising effective oversight of information-era activities. The information-era regulatory models that have begun to emerge are procedurally informal, mediated by networks of professional and technical expertise that define relevant standards, and financialized. Such models, however, also have tended to be both opaque to external observation and highly prone to capture. New institutional forms that might ensure their legal and political accountability have been slow to develop.'A Trojan Horse? How an Expanding First Amendment Threatens the FDA Pre-Market Approval System and Much of the Modern Regulatory State' by Christopher T. Robertson in (2017) Ohio State Law Journal (Forthcoming) comments
Scholars, advocates, and courts have begun to recognize a First Amendment right for drugmakers to promote their products “off-label”, without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Review of the seven arguments deployed in the off-label domain finds that they cannot be so limited. Instead, if they were valid, they would undermine the FDA’s entire premarket approval regime, reopening the door to a snake oil market where hype replaces science. Even more, if valid, this First Amendment logic would undermine a wide range of statutory regimes that have similar intent-based structures and rely on speech as evidence of intent. Ultimately, with relevance to First Amendment theory, this article reveals a broad and longstanding coherence in the law.