medical backgrounds, and social pressure to make any effective treatment available. Use of depot medications, such as naltrexone, for treating alcoholism are likely to be well informed by the FDA approval process, but other uses of depot naltrexone, such as treatment of heroin dependence, may not have been carefully studied.

Recommendation 2 Recognizing that immunotherapy medications will be used in off-label situations that have not been specifically approved by the Federal Drug Administration, the National Institute of Drug Abuse should support preclinical studies addressing the potential safety and efficacy of these medications when given to vulnerable populations (e.g., pregnant women and their fetus, adolescents, etc.). Long-term studies should be done with laboratory animals of different ages, as well as their offspring, before trials with vulnerable human populations are undertaken.

Recommendation 3 The National Institute on Drug Abuse should support studies of the likely extent and nature of off-label drug use, including factors and incentives that would promote or retard such use, and the opportunities for policy makers to intervene should the patterns of off-label use depart from what is in the best interest of the society.



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