Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. DEA Regulation


DEA regulation was not generally cited by pharmaceutical company representatives as a market barrier. One interviewee mentioned the potential risk of exposing an existing successful product used for other indications to cocaine treatment. The company indicated that the increase in development costs of the drug and the potential for rescheduling of the drug could restrict the market opportunities for its original indication and market.

The case study of LAAM, which is regulated by the DEA as a Schedule II drug, demonstrates how DEA regulation can be a hurdle for drug development. This regulation places severe restrictions on distribution channels, primarily in order to prevent the drug from being diverted to the black market. DEA scheduling prevents a drug from being marketed in a state until that state has rescheduled the drug, and state rescheduling could delay product marketing by years.

It is highly unlikely that an existing product would meet the criteria for being rescheduled by the DEA. In order for a currently marketed product to be rescheduled because of its use in cocaine dependent persons, it would have to meet two criteria: 1) the drug must have abuse liability, and 2) the drug must be classified as a narcotic. While methadone and LAAM meet these criteria, naltrexone is not scheduled. In addition, products with abuse potential are scheduled at the time of their NDA approval, and if an existing product showed higher or lower than expected abuse liability after marketing, it could be rescheduled upwards or downwards, regardless of whether it ever was used in a cocaine dependent population (Cummings, 1997).