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Executive Summary

DRUG DIVERSION BILL EMERGENCY SCHEDULING EXEMPTION should be specifically granted to investigational drugs, PMA urged in recent comments submitted to House Health Subcmte. Chairman Waxman (D-Calif.). Commenting on the proposed provision giving the Justice Dept.'s Drug Enforcement Administration emergency drug scheduling authority, PMA said that an amendment should be added to "explicitly prohibit the emergency scheduling of pharmaceutical products having accepted medical use in the U.S. or which are being investigated to establish that use." The bill was introduced by House Judiciary Courts Subcmte. Chairman Hughes (D-NJ). Although the bill was amended by the House Judiciary's Courts Subcmte. in April to limit emergency scheduling authority to only those substances with "no currently acceptable medical use," PMA contended that the provision could be interpreted to allow emergency scheduling of investigational drugs. The assn. asserted that the bill "could permit the attorney general to temporarily schedule a compound which is the subject of an investigational new drug exemption (IND) because, technically, many IND drugs have no currently accepted medical value since they have not yet been approved by FDA for marketing." PMA submitted the comments following a July 31 hearing by the House Health & Environment Subcmte.

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