Some Remarks about “Approval”

The government extensively controls the system of drug development, production, and usage. In exercising control, the government apparatus develops and institutionalizes a vocabulary. Terms within the “official” vocabulary often mean something more than, or different from, what they mean in ordinary language. Being aware of the complexity of meaning helps us to grasp the workings of the apparatus.

The term approval calls for special scrutiny. In ordinary society, if someone approves a product, he or she regards it with favor, affirms its value, and perhaps endorses the product. Once upon a time, adult Americans were free to produce, trade, and use drugs according to the ordinary constraints of property and consent. At that time, if a doctor, pharmacist, or medical association approved a drug, it meant that they affirmed its value. In the case of an organization that rates or certifies quality and safety, approval means to endorse or grant certification to a product. Today, Good Housekeeping approves the products to which it grants the Good Housekeeping Seal of Approval, and Underwriters’ Laboratories approves the products to which it grants the UL mark of safety.

All those forms of approval are voluntary. When it comes to FDA approval, however, the FDA grants not only its own seal of approval but also permission for citizens to use the drug. Until the FDA approves the drug, citizens are forbidden by federal law from producing, selling, or using the drug. Anyone who refuses to obey the FDA will eventually face armed federal agents, confiscation, and imprisonment. (The FDA has its own armed inspectors, many trained as DEA or Secret Service agents, and it has conducted SWAT-like raids.) FDA “approval” therefore means, above all else, federal officials withdrawing certain coercive threats and refraining from certain coercive actions. The language of “approval” connotes the useful work of evaluating products and granting a seal of approval. Thus, the newspapers report that “The FDA today approved a drug that will save thousands of lives.” It would be more accurate, however, to report that “The FDA today lifted the ban on a drug that will save thousands of lives.”

It should be noted that, although the FDA might, within the framework of existing legislation, be much more oriented toward letting manufacturers, doctors, and patients engage in consensual transactions and might recommend liberalizing amendments, it cannot rightly ignore the restrictions that legislation places on Americans. The fundamental flaw of federal drug policy lies, therefore, not within the FDA itself but within the enabling legislation.