Modern government offers few if any agencies more powerful, more watched, or more pressured than the U.S. Food and Drug Administration (FDA). Rough estimates suggest that the FDA regulates more than one quarter of U.S. gross domestic product, with primary responsibilities for food, pharmaceuticals and medical devices, cosmetics, and, since 2009, tobacco products. Over a wide range of these products – drugs, medical devices, food additives, and certain tobacco products – the FDA has expansive gatekeeping power: the congressionally mandated task of deciding whether the products in question can be marketed at all. Gatekeeping power has many facets. Gatekeeping can be used to protect the public or provide it with false confidence; create market-wide confidence in new products; enhance or stifle innovation (often both); snow and guile consumers into thinking that poor, unsafe products are safer and better than they are; and hone the production, dosage, and information about drugs to help doctors and patients optimize their use.

If ever there were a plausible prima facie case for capture, a gatekeeping regulator like the FDA would seem to provide it. In its governance of pharmaceuticals, the FDA regulates a vast industry, one that supplies a global market approaching $1 trillion in size. Given its size and its historical connections to science and technology, this industry possesses broad economic, political, and cultural power. When Samuel Huntington and Marver Bernstein wrote about the potential capture of regulatory agencies in the 1950s and 1960s, it was with just such an agency-industry relationship in mind (although neither wrote about the FDA). Large industries like these would seem to be primed to limit entry and preserve market access for themselves. And when George Stigler looked for examples of when “regulation is acquired by the industry,” he found his examples among entry-limiting regulation: weight limits for trucks (shaped by the lobbying of railroads and farmers) and occupational licensing (in which those with market power limit the entry of their potential competitors, restraining supply and inflating equilibrium price).