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Executive Summary

DRUG ABUSE TREATMENT R&D LEGISLATION BY SEN. BIDEN will be introduced after the Senate reconvenes in January. The legislation will implement a series of recommendations made in a Dec. 13 staff report by the Senate Judiciary Committee, which Biden (D-Del.) chairs. The recommendations include the establishment of a renewed "Medications Development Program" within the National Institute on Drug Abuse (NIDA) to accelerate research and development of drug addiction treatments or "pharmacotherapies." The new program would be funded at approximately $ 1 bil. over the next 10 years. The Medications Development Program was established by the Anti-Drug Abuse Act of 1988, which authorized $ 10 mil. for NIDA to set up a program to develop treatment drugs. The committee "recommends that the Medications Development Program be renewed, codified, and made permanent." Among the primary goals expressed by the committee are: "bringing a pharmacotherapy for cocaine dependency to the marketplace by 1996, and providing pharmacotherapeutic treatment on demand for both heroin and cocaine dependencies by 2000." The report lists eight of the "most promising" drug addiction therapies. The drugs are divided into three categories: treatments for opiate addiction; treatments for cocaine addiction; and treatments for "poly-drug" (cocaine/heroin) addiction. Only two of the drugs are approved for drug abuse treatment, methadone (Lilly's Dolophine) and naltrexone (DuPont's Trexan). One other, naloxone (DuPont's Narcan) is approved as an antidote to opiate overdose but is widely used as a detoxifier. Other drugs, approved for unrelated indications but being studied for drug addiction treatment, include: Marion's Cardizem (diltiazem); Ciba-Geigy's Tegretol (carbamazepine) and Tofranil (imipramine); and Norwich Eaton's Buprenex (buprenorphine). The committee recommends that incentives like those available under the Orphan Drug Act be applied to treatments of drug abuse. The report refers to a provision of the Senate-passed drug reform bill, S 1711, which set up an incentive program modeled on the Orphan Drug Act to encourage the development of drug abuse therapies. The provision was sponsored by Biden and Sen. Kennedy (D-Mass.) ("The Pink Sheet" Oct. 9, T&G-10). The committee also advises that the Orphan Drug Act be modified to provide "patent-like" protection to the "manufacturing rights of companies whose drug patents have expired prior to their discovering new indications, or uses, for those drugs." The committee recommends that two innovative FDA procedures that have been used to speed drug approvals in the AIDS area -- Treatment INDs and parallel track trials -- be used for pharmacotherapeutics. The committee further recommends that FDA forego its "mechanism of action" requirement for approval. In addition, the committee directs that a Surgeon General's report on pharmacotherapy be issued by March 1, 1991.

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