The Case for Less, Not More, US FDA Regulation

Excerpt

The article by Neumann et al.[1] in this issue is an important contribution to the literature; one that sheds much light on a heretofore largely overlooked aspect of Section 114 of the 1997 Food and Drug Modernization Act (FDMA). The article describes how Section 114 has been interpreted and used by major US pharmaceutical firms with respect to the dissemination and communication of a pharmaceutical product’s economic value to health plans, formulary decision makers and similar organizations. The authors’ argument for greater clarity on the topic by the US FDA deserves to be echoed loudly, as does their appeal for flexibility with respect to its interpretation. The article,[1] which fills a long-standing lacuna in the literature, is particularly timely, as the authors of the article emphasize, because new and evolving comparative effectiveness research (CER) legislation will potentially affect many Section 114 claims. …