Pharmaceutical Executive: What do you think is the biggest misconception inside the pharma industry about the FDA?
PE: The title of your book—"Reputation and Power"—highlights two themes at the heart of your approach to understanding the FDA. The reference to "reputation" may surprise many readers. As you explain in the book, reputation offers an alternative to the two most common (and opposing) ideological views—"regulatory capture" (the FDA as a servant to industry and its interests) and "regulatory overreach" (the FDA as an obstacle to industry and its innovations). Why this emphasis on reputation?
A reputation-based perspective succeeds where "capture" and "overreach" hypotheses fail. The "capture" explanation fails to account for most of the FDA's history, as many of the FDA's growing powers were strongly opposed by the pharmaceutical industry and the American Medical Association. An "overreach" hypothesis ignores the FDA's record of flexibility on a host of drugs, from HIV to cancer and even alternative medicine.
I'm not saying that a reputation-based account gets everything right, but it suggests that under some conditions the agency's approach to pharmaceutical innovation will be stringent and cautious; under other conditions, the FDA will be facilitative of drug development and will emphasize safety less (postmarket regulation is an example, until recently).
PE: What is the relationship between the political context of "power" and regulation as it plays out at the FDA?
DC: I understand power in three ways: directive, gate-keeping, and conceptual. Directive power is the ability of the FDA to order companies to do things such as inspections and manufacturing requirements. Gate-keeping power is the power that results from the FDA's ability to veto a new drug. When companies abandon what may appear to be an apparently promising and profitable compound in Phase II because they think that it will not meet the FDA's approval criteria, we rarely see that reported in the news. Yet the FDA's power has been exercised nonetheless, because companies and medical researchers are anticipating the FDA's behavior to inform their decisions.
Conceptual power is the ability of the FDA to shape the vocabulary, methods, and tools of medicine and drug development. The three-phase system of clinical trials and the architecture of bioequivalence are examples where the FDA officials established processes that have been replicated throughout the world, affecting the very nature of science.