REP. WAXMAN's SYNTHETIC HUMAN GROWTH HORMONE BILL

Executive Summary

REP. WAXMAN's SYNTHETIC HUMAN GROWTH HORMONE BILL was moved to the House on Oct. 17, after it had been placed on the House floor calendar. Introduced on Oct. 6 & 10, the measure would require Schedule II controls of somatrem (Genetech's Protropin) and all other synthetic growth hormone products under the Controlled Substances Act. The California Democrat told the House his legislation would "provide appropriate safeguards against the deliberate and potentially life-threatening abuse of this product . . . while scientific research continues." The bill is not expected to clear the House. The bill would not "limit the proper use of this drug, nor would it inhibit necessary research," he added. The legislation is aimed at use of the drug to enhance size and strength by athletes. The potential harm from such use has not been documented with somatrem, as it has with anabolic steroids. The drug is therapeutically indicated for dwarfism in children. Waxman's legislation was expected to meet with opposition in the Senate. Protropinmanufacturer Genentech opposed the bill. The company told "The Pink Sheet" that the bill would increase costs for consumers by requiring repeated physician visits because Schedule II Rx drugs are not refillable. In addition, the company maintained, the recordkeeping requirements of the Drug Enforcement Administration (DEA) controls would place an unnecessary burden on physicians and manufacturers of synthetic growth hormones. Finally, Genentech said, decisions on Rx drug controls are properly made by FDA and DEA rather than the Congress. The company contended that there are no similarities between Protropin and Schedule II drugs.