Constitutional law is a problem-solving activity. All problems in constitutional law, without exception, can be analyzed in terms of one or more questions, and all constitutional law questions, without exception, fall into one of two distinct categories: Does the Constitution authorize this governmental action? and does the Constitution prohibit this governmental action? This twofold logic of inquiry into authorization and prohibition guides the constitutional lawyer’s analysis of the problem in a constitutional controversy and provides the intellectual skeleton for constitutional law argument and decision. This chapter will first discuss how the logic of inquiry is used, and then will explain how the two questions are the product of the way the written Constitution is worded and of certain background presuppositions about its purposes.

We argue that changing how postmarket studies are conducted and who evaluates them might mitigate some concerns over the agency’s increasing reliance upon RWE. Distributing the responsibility for designing, conducting, and assessing real world studies of medical devices and drugs beyond industry sponsors and the FDA is critical to producing – and acting upon – more clinically useful information. We explore how the DESI program provides a useful model for the governance of RWE today. We explain why the FDA’s Center for Devices and Radiological Health is the most promising site for a new DESI initiative inspired by the challenges of regulating drugs in the past.

In Leviathan, Hobbes uses his new theory of authorization to explain the nature of corporate persons. While On the Citizen lacks the theory of authorization, it includes several accounts of corporate persons. In On the Citizen, Hobbes suggests that a group forms a corporate person when its members accept obligations to support a sovereign, when the members are all compelled to act in concert, or when the members of the group adopt voting rules for making decisions. Hobbes also uses his analysis of the commonwealth as a corporate person to argue for the sovereign’s immunity in On the Citizen much as he does in Leviathan. Generally speaking, the Leviathan account of corporate persons is superior to the ones in On the Citizen. However, Hobbes needs the voting rules account from On the Citizen in order to explain how democratic and aristocratic assemblies can serve as sovereigns. Since he tries to replace the voting rules account with the authorization account in Leviathan, this raises a problem for him that he does not appreciate.