February 16, 2011


Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton & Oxford: Princeton U. Press, 2010) ("No new drug can be legally marketed in the United States unless the [Food and Drug] Administration has explicitly declared it 'safe and effective' for its intended uses. This authority renders the FDA the gatekeeper of the American pharmaceutical marketplace, and it sustains a battery of vast powers. . . . Among the thousands of people who daily give painstaking attention to the agency's every utterance and movement, there is considerable disagreement about the Food and Drug Administration--it is venerated in one corner and bemoaned in another; it is targeted for expansion by one voice, for evisceration by a second--but there is no serious doubt about its reach or significance." "The Administration's formal powers engender a broader and more opaque set of informal forces. From one vantage, the agency's formal authority is limited to the jurisdictions and territories of the United States. It legally tends the boundaries of only one nation. From another vantage, however, the FDA rules the entire global pharmaceutical market. The United States is among the world's wealthiest nations and its pharmaceutical market is, at this time, by the far the world's largest. And it has exploded in recent decades; the American market accounted for $216 billion in spending on prescription drugs in 2006, more than five times the $40.3 billion spent in 1990. At this writing, furthermore, the United States is the only major world economy without explicit pharmaceutical price controls through national health insurance. Because admission to the U.S. market is the preeminent site of profit for the world's drug companies, the FDA's veto power over entry into the American health-care system translates into global economic and scientific reach. Beyond this, the Administration carries a stature that other agencies in foreign nations consciously emulate or resist. Pharmaceutical regulators in Australia, Brazil, Egypt, France, Germany, Great Britain, India, Israel, Japan, South Korea, Switzerland, and dozen of other countries and regions model themselves upon the FDA, and in some cases contrast themselves against it." Id. at 1-2. This book should be high on the recommended reading list, if not a required reading, for all law students. The typical law student graduates with little knowledge of the structure, power and politics of any administrative agency let alone this very broad, very powerful FDA. This history of the FDA would begin to fill a deep gap in the student's understanding of how regulation actually works. It will also underline the little secret that lawyers qua lawyers are not at the center of regulation.).