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Executive Summary

KENNEDY, BIDEN BILLS WOULD PROVIDE EXCLUSIVITY FOR DRUG ABUSE TREATMENTS; Sen. Kennedy's (D-Mass.) S 2649 and Sen. Biden's (D-Del.) S 2650 were introduced May 17 with identical provisions to encourage the development of "pharmacotherapies," or treatments for drug abuse. The provisions include a section modeled on the Orphan Drug Act that would offer approved drug abuse treatments seven years of marketing exclusivity. Biden's bill is a broad piece of legislation designed to implement a national drug abuse prevention strategy. The measure has been referred to the Judiciary Committee, which Biden chairs. No action on the bill has been scheduled. Kennedy introduced his bill separately because the provisions on drug abuse treatment and prevention fall under the jurisdiction of his Labor & Human Resources Committee, according to staff. The Labor Committee plans to mark up Kennedy's bill in late June or July. Identical in both bills, the provision on market exclusivity states: "the [HHS] Secretary may not approve another application...issue another certification...or issue another license...for such drug for the treatment of such addiction for a person who is not the holder of such approved application, of such certification, or of such license until the expiration of seven years from the date of the [initial] approval." The exclusivity provision is based on a staff report issued by the Judiciary Committee Dec. 13 ("The Pink Sheet" Dec. 18, T&G-10). That report referred to the drug reform bill passed by the Senate last fall, which included a provision sponsored by Kennedy and Biden to set up an incentive program modeled on the Orphan Drug Act. Kennedy's new bill would also require HHS to look at advertising and marketing of legal drugs in the context of a study on the correlation between consumption of legal and illegal drugs. Specifically, the study would look at "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." The Biden bill includes provisions requiring that anabolic steroids be listed as Schedule II substances under the Controlled Substances Act. The bill would also establish stiff penalties under the FD&C Act for illegal use of human growth hormone, adding that such a violation would be considered a felony under the Controlled Substances Act. Both bills encourage use of open protocols for investigational drugs. "The Secretary may encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with such addictions who need the drug...and who cannot be satisfactorily treated by available alternative drugs," the provisions state. The bills allow sponsors of INDs for drug abuse treatments to submit applications in parts, as the information becomes available. If FDA finds problems with parts of the application, the bills allow sponsors to resubmit only those parts of the application that are unacceptable rather than resubmitting the entire application. The bills also propose that the agency allow for "parallel track" (open-label) development of pharmacotherapies. FDA "may permit parallel track trials to be used to permit access to such drugs in a manner similar to that applied in certain medications to treat individuals infected" with HIV. The legislation mandates the establishment within the National Institute on Drug Abuse of a division on "medications development" that would draw up new guidelines for FDA on safety and efficacy trials of medications to treat drug addiction. The bills further require a report by the U.S. Surgeon General by Jan. 1, 1992 on the state of the national strategy for developing such treatment and recommendations for improvement.

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