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FDA HUMAN GROWTH HORMONE DIVERSION INVESTIGATIONS

Executive Summary

FDA HUMAN GROWTH HORMONE DIVERSION INVESTIGATIONS have not demonstrated that the products are being diverted, FDA indicated at an April 27 meeting with health professionals. The agency said that it had investigated reports of diverted human growth hormone (hGH) -- both the natural form previously available and the recombinant form now marketed -- but was unable to substantiate the reports. The only evidence of hGH diversion, FDA said, are "rumors" that it occurs. FDA was asked to comment on diversion of hGH in light of Rep. Waxman's (D-Calif.) Energy & Commerce Health Subcommittee April 8 hearing on the proposed placement of the products into Schedule II of the Controlled Substances Act. At the health professionals meeting, a representative from the American Medical Association asked whether the agency felt that hGH should be subject to controlled subtances scheduling given that it is not psychoactive. FDA Associate Commissioner for Health Affairs Stuart Nightingale, MD, responded he doesn't believe that hGH or other non-psychoactive substances should be subject to scheduling. FDA Deputy Commissioner Norris told the health profesionals that the agency's Action Plan-Phase II would be publicly released soon. The document "will be out momentarily," Norris said. "It has already been approved by the assistant secretary for health" and may receive final department clearance "sometime this week." He noted that "the highest priority under Phase II" is facilitating the development of AIDS therapies. Other areas that will be highlighted in the plan include postmarketing surveillance and enforcement of imported products. Norris noted that FDA's enforcement activities have typically focused on domestic products. The Action Plan-Phase II will attempt to bring enforcement resources for import products up to the level for domestic products. "We can't inspect [all foreign] plants," Norris said, "but we can look at the docks."
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