Feeling Better: What is the FDA doing, and how is it doing it? image

The Weekly Standard, March 21, 2016
Devorah Goldman, reviewing FDA in the 21st Century by Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

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Excerpt from the article:

[...] In his last State of the Union address, Barack Obama asked, “How do we make technology work for us and not against us?" This was one of Obama's four "big questions" during his speech, and the audience cheered as he asked it—for good reason. It echoes the fears of regulators everywhere.

These fears are thoroughly and mostly honestly addressed inFDA in the 21st Century. As the title suggests, the emergence of new drugs and technologies has been disconcerting for the U.S. Food and Drug Administration. The rapid-fire pace of medical progress in the 21st century, particularly the remarkable strides made in personalized medicine, has called into question the FDA's purpose in the regulatory universe.

The list of contributors here is telling: It is written mainly by lawyers, with a smattering of Ph.D.s and just four M.D.s (two of whom are also a lawyer and a Ph.D., respectively). This book is the result of a 2013 symposium at Harvard Law School, and it shows: It is primarily written for, and about, the interests of regulators. Physicians, patients, and drug developers are rarely heard from in the 500-plus pages spent discussing medical policies. [...]

fda health care reform holly fernandez lynch i. glenn cohen regulation