Zero-Credit Politics

This chapter examines how the politics surrounding efforts to address the medical evidence problem have been “unhealthy.” It shows that while the pragmatic case for bringing standardized evidence more systematically to bear on decisions in health care is compelling, federal politicians took only modest actions to support steps to identify and eliminate wasteful, unnecessary services between the 1970s and late 2000s. Moreover, politicians (responding to their electoral incentives) were quick to abandon even these incremental reforms when they sparked opposition from providers and the medical products industry. In sum, the government's performance as a problem-solving institution with respect to health care quality and efficiency was doubly disappointing. First, the medical guesswork problem was a low-priority concern, barely registering on the policy agenda; it was an “inside initiative” in which the conversation excluded both politicians and the general public. Later, when the medical evidence problem began to generate the broad attention it deserved, proposed solutions became the object of partisan manipulation and political distortion.

Transparency at the U.S. Food and Drug Administration

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.