Understanding the FDA’s Opposition to Liberalization

By granting people more freedom while maintaining the option of FDA seals of approval and certifications, many of the foregoing reform proposals expand options without taking away anything beneficial. These proposals might strike the reader as remarkably simple and sensible, so why does the FDA resist them? The answer is provided by basic economics. Government enterprise, lacking the fusion of motivation and decisive authority in private ownership, simply cannot compete in a field of open competition. To survive, government enterprise needs to receive either tax dollars (e.g., government schools) or privileges against competition (e.g., the U.S. Postal Service). The FDA currently receives both, but especially the latter. If privileges against competition (in permitting new drugs or in granting seals of approval) were removed, the FDA would probably sink like a stone, and FDA officials know it. Liberalizations such as allowing Not FDA Approved claims, international reciprocity, or voluntary certification would probably be tantamount to killing the FDA altogether because people would simply say, “No, thank you” to its services.

Our point is captured by the description in Miller (2000) of the FDA’s attitude toward reciprocity: “the FDA has been consistently recalcitrant on the pivotal issue of reciprocity of approvals. . . . [W]hen asked by the author how negotiations were progressing, a high-ranking European regulator . . . quipped, ’Discussing reciprocity with FDA is like discussing the Thanksgiving menu with the turkeys’” (57).

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