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Executive Summary

SEN. KENNEDY's DRUG ABUSE TREATMENT BILL ADOPTED SEPT. 12 by a unanimous vote of his Senate Labor & Human Resources Committee. The measure (S 2649) was offered by the chairman (D-Mass.) as a substitute version of his original bill. Title III of the bill includes a treatment research initiative program developed by Kennedy and Sen. Biden (D-Del.). However, unlike the original version of the bill ("The Pink Sheet" June 4, T&G-3), the substitute does not offer market exclusivity incentives to developers of drug abuse treatments, or "pharmacotherapies." Other provisions relating to speeding FDA review of INDs have been retained in the bill. The bill would permit IND sponsors to submit applications or protocols in parts. If FDA withholds approval of any part of the application or protocol, the agency may require the resubmission of only that part of the application or protocol. FDA must respond to applications within 30 days, the bill states. The measure further directs FDA to permit parallel track trials for drug abuse medications in order "to permit access to such drugs in a manner similar to that applied to individuals infected with HIV." The FDA may also waive the "mechanism of action" requirement for marketing approval of such drugs. The legislation contains a diluted version of the original bill's provision requiring HHS to conduct a study including the impact of advertising and marketing practices on use of legal drugs. The substitute version requires HHS to conduct a study first on a possible correlation between abuse or consumption of illegal and legal drugs, and then consider the need for a study on the impact of advertising and marketing on prescribing. In its requirement for an HHS study on the relationship between the consumption of legal and illegal drugs, the legislation directs the department to "review and consider all existing relevant data and research concerning whether there is a relationship between an individual's receptivity to use or consume legal drugs and the consumption or abuse by the individual of illegal drugs." If HHS determines additional research is warranted, additional studies will be conducted, the measure states, including a review of "the effect of advertising and marketing campaigns that promote the use of legal drugs on the public and the correlation of legal drug abuse with illegal drug abuse." A report on the first part of the review is to be submitted to the House Energy & Commerce Committee and Senate Labor & Human Resources Committee one year after enactment; additional studies would be due two years after enactment. The bill also calls for an FDA study on private sector development of pharmacotherapeutics, to be submitted one year after enactment. "Such report shall contain legislative proposals designed to encourage private sector development of anti-addiction medications." The legislation defines "pharmacotherapies" as drugs to treat the symptoms and disease of drug addiction. The bill states that it is the "sense of the Congress" that the Medications Development Division of the National Institute on Drug Abuse should devote particular attention to development of: a methadone alternative; a long-acting narcotic antagonist; a cocaine-blocking treatment; a cocaine-blocker/narcotic antagonist treatment; treatments for addictions to drugs such as methamphetamine; medications to safely treat pregnant addicts and their fetuses; and medications to treat the offspring of addicted mothers. The bill also would establish a "Medications Development Program" within the Alcohol Drug Abuse and Mental Health Administration to "encourage and promote...expanded research programs, investigations, experiments, and studies, into the development of medications to treat drug and alcohol addiction and related mental disorders." The measure authorizes $60 mil. in 1991 for the program.



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