The CIOMS III Criteria for Labeling Changes: A Survey at Schering-Plough

Abstract

The Council for International Organizations of Medical Sciences (CIOMS) III working group has published a report attempting to harmonize and set criteria for drug labeling. The group identified and ranked 39 criteria to determine the threshold for adding adverse events to the labeling of marketed drugs. A survey was taken in several departments of the Schering Corporation to determine whether these criteria would be ranked in a similar manner. The results showed that there was a high degree of correlation in the rankings (0.79) with the greatest correlation being seen in the drug safety groups both in the United States-based home office (0.88) and in the non-United States subsidiaries (0.74). It is concluded that there is a large degree of agreement between the criteria for addition of adverse events to product labeling proposed by the CIOMS group and at least one major pharmaceutical company.