FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

FDA in the 21st Century is an excellent edited volume based on the Petrie–Flom Center’s1 2013 Annual Conference.2 The conference sought to gather thought leaders in academia, government, and private industry to evaluate the Agency and to make recommendations for Food andDrug Administration’s (FDA’s) future functioning. Peter Barton Hutt referred to it as, ‘unquestionably the largest, comprehensive symposia on food and drug law literally that has ever been held’.3 Conference presenters (together with a few follow-on submitters) subsequently contributed essays to FDA in the 21st Century. The book’s editors argue that their efforts are timely, given that the Agency is being faced with new challenges in the form of big data, personalized medicine, and increased globalization, together with longstanding problems related to funding, industry relations, and consumer access. Although, as a food and drug law aficionado myself, I do not think there is ever a bad time to have a book about FDA. Of the book’s 27 chapters, only one appears to have online open-access: the book’s introduction by editors Holly Fernandez Lynch and I. Glenn Cohen (at SSRN).4 The introduction describes each chapter’s substance, so I will not attempt to reduplicate that content here. The book’s essays are on a diverse range of topics, although the editors have sorted them into broad themes. After the introduction, the volume starts with an engaging