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dronabinol (tetrahydrocannabinol, or THC, in sesame oil), the only approved cannabinoid in the United States. These sections serve as a road map to determine whether the therapeutic potential of cannabinoids is likely to be exploited commercially to meet patient needs. Finally, the chapter describes what would be needed to bring marijuana to market as a medicinal plant.

The term cannabinoids is used in this chapter to refer to a group of substances that are structurally related to THC—by virtue of a tricyclic chemical structure—or that bind to cannabinoid receptors, such as the natural ligand anandamide. From a chemist's point of view, this definition encompasses a variety of distinct chemical classes. But because the purpose of this chapter is to explore prospects for drug development, both chemical structure and pharmacological activity are important; therefore, the broader definition of cannabinoids is used.

Federal Drug Development Policy

Like controlled substances, cannabinoids developed for medical use encounter a gauntlet of public health regulatory controls administered by two federal agencies: the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (DHHS) and the Drug Enforcement Administration (DEA) of the U.S. Department of Justice. The FDA regulates human testing and the introduction of new drugs into the marketplace, whereas the DEA determines the schedule of and establishes production quotas for drugs with potential for abuse to prevent their diversion to illicit channels. The DEA also authorizes registered physicians to prescribe controlled substances. Some drugs, such as marijuana, are labeled Schedule I in the Controlled Substance Act, and this adds considerable complexity and expense to their clinical evaluation. It is important to point out that Schedule I status does not necessarily apply to all cannabinoids.

Food and Drug Administration

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA approves new drugs for entry into the marketplace after their safety and efficacy are established through controlled clinical trials conducted by the drugs' sponsors.23 FDA approval of a drug is the culmination of a long, research intensive process of drug development, which often takes well over a decade.19,44 Drug development is performed largely by pharmaceutical companies, but some targeted drug development programs are sponsored by the National Institutes of Health (NIH) to stimulate further development and marketing by the private sector. The NIH's drug devel-

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