INTERNATIONAL DRUG LABELING STUDY's SCOPE BEING NEGOTIATED

Executive Summary

INTERNATIONAL DRUG LABELING STUDY's SCOPE BEING NEGOTIATED by Rep. Waxman (D-Calif.) and other principal cosponsors of the omnibus health care bill. Waxman drafted a letter to the Office of Technology Assessment (OTA) shortly after the omnibus legislation was signed into law. Certain legislatores who agreed to sign the request reportedly are now concerned that the letter as drafted asks for too vast and impractical a study. Rep. Waxman (D-Calif.) wanted to include a provision in drug export legislation to require an OTA study comparing drug labeling in developed v. Third World countries. During eleventh-hour negotiations on the omnibus health care bill, the proposal was dropped from the legislation, but it was agreed that Waxman would draft a letter requesting OTA to conduct the study and that it would be signed by Waxman, Rep. Madigan (R-III.), Rep. Wyden (D-Ore.), Sen. Hatch (R-Utah), and Sen. Kennedy (D-Mass.). The draft asks OTA to examine all human drugs, antibiotics and biologicals marketed by U.S. companies in eight nations -- including Brazil, Indonesia, Mexico, Nigeria and the Philippines. OTA should examine the claims, contraindications, warnings and adverse effects, the draft states, to determine whether information is based on sound, objective data, including clinical trials, and, for drugs also sold in the U.S., whether differences from U.S. labeling are based on such data. The letter also urges OTA to ask the foreign governments the medical basis for labeling approval. The letter suggests that OTA appoint an advisory committee of experts in drug labeling. It asks OTA to begin collecting foreign labels within three months and to complete the study within two years.