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Executive Summary

FDA DRUG ABUSE TESTING GUIDELINES: EARLY IDENTIFICATION OF ABUSE potential is being sought by the agency through the development of guidelines. FDAs Drug Abuse Advisory Committee's Subcommittee on Guidelines for Animal and Human Abuse Liability Testing met on Jan. 8-9 to discuss preliminary ideas for the development of drug abuse testing guidelines. "What we are seeking in the development of guidelines is, hopefully, the early recognition of the likelihood that a substance will be abused, "something that researchers may necessarily [be] looking a drug," Michael Klein, FDA Drug Abuse Staff, said. When the issue of drug abuse liability comes up in late stages of drug development, he explained, "we have to initiate evaluations of abuse liability, and it can add quite a considerable amount of time onto the studies" and can delay the drug's introduction into the market. Klein noted that once abuse potential is identified, tests should be "performed to further characterize [its] abuse liability and potential to create dependence." The subcommittee plans to submit a report on its guideline recommendations to the full Drug Abuse Advisory Committee, which will meet Jan. 22-23. Only the full committee has the authority to recommend proposed guidelines to FDA. Subcommittee members noted that they would also like to get input from the Committee for Problems of Drug Dependence, which is supposed to meet this summer. From the outset of the meeting, it was emphasized that the guidelines should be flexible. FDA Pilot Drug Evaluation Unit Director John Harter, MD, stated: "I don't believe guidelines should be cookbooks...because if you make them cookbooks...what you do is freeze the recipe and it's very [hard] to keep moving along with the science." Industry participant David Downs, PhD, director of the neurosciences research division at Warner-Lambert, concurred: "I would prefer to see guidelines relatively vague." He noted that "technology and techniques evolve and develop as time goes by and what guidelines we set today, the state-of-the art today, is going to be very different a year from now." Harter stressed the importance of guidelines given the recent movement of the Drug Abuse Staff from the Neuropharmacology Drugs Division to the Pilot Drug Evaluation group. In "taking the Drug Abuse Staff out of the neuropharmacology group, these drugs are no longer screened," Harter said. Guidelines will help determine which drugs need to be referred for screening, he added. Klein noted that guidelines are needed to "guide the different elements within FDA" as to whether the abuse liability of a drug should be evaluated. Meeting participant Donald Jasinski, MD, suggested that the guidelines require "that all NDA submissions have as part of their submission some discussion of potential or lack of potential for abuse." Curtis Wright, MD, Drug Abuse Staff, pointed out that "there is in fact a requirement...that some discussion of drug abuse [potential] be supplied. But, what we're really talking about is what should be in that section." An example, he noted, would be: "What happens with dose-escalation?" FDA would like more abuse liability information to go into drug labeling, Wright noted. The agency would "like to provide an information rich paragraph to the prescribing physician that integrates the animal and human data as best we can, along with what epidemiological evidence is available, that provides the basis for a reasonable judgment of the abuse liability of the drug."

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