Drug Control And Development

DRUG CONTROL AND DEVELOPMENT

Before the twentieth century, most government controls were concerned not with drugs but with impure and adulterated foods. Medicines were thought to pose problems similar to those presented by foods. Efficacy was questioned in two respects: adulteration of active medicines by addition of inert fillers and false claims made for the so-called patent (secret) medicines or nos-trums. Indeed, much of the development of the science of pharmacy in the nineteenth century was standardiz-ing and improving prescription drugs.

A landmark in the control of drugs was the 1906 Pure Food and Drug Act. Food abuses, however, were the primary target. Less than one quarter of the first thousand decisions dealt with drugs, and of these, the majority were concerned with patent medicines.

The 1906 law defined drug broadly and governed the labeling but not the advertising of any substance used to affect disease. This law gave the Pharmacopoeia and the National Formulary equal recognition as authorities for drug specifications. In the first contested criminal pros-ecution under the law, action was taken against the maker of a headache mixture bearing the beguiling name of Cuforhedake-Brane-Fude. In 1912, Congress passed an amendment to the Pure Food and Drug Act that banned false and fraudulent therapeutic claims for patent medicines.

Prescription drugs also were subject to control un-der the 1906 law. In fact, until 1953 there was no fixed legal boundary between prescription and nonprescrip-tion medications. Prescription medications received a lower priority, since food and patent medicine abuses were judged to be the more urgent problems.

For the next 30 years, drug control was viewed pri-marily as a problem of prohibiting the sale of dangerous drugs and tightening regulations against misbranding. Until the 1930s, new drugs posed little problem because there were few of them.