ABSTRACT
<b>Objective: </b>If product information provided by pharmaceutical manufactures is not consistent with a product assessment made by the Pharmaceuticals and Medical Devices Agency (PMDA), users may gain false perceptions about the product, which may be detrimental to patients. An investigation was conducted to compare the contents of product information provided by pharmaceutical manufacturers and product evaluation reports prepared by PMDA to identify any discrepancies between data assessment in the two documents.<br><b>Methods: </b>Descriptions in “Product Characteristics” and “Clinical Studies” of product information summaries were compared with product evaluation reports prepared by PMDA. Inquiries were addressed to manufacturers if any questions arose.<br><b>Results: </b>The investigation was conducted on 66 new active ingredients approved in 2009 to 2010. As 14 questions arose with 12 ingredients, inquiries were addressed to manufacturers, all of whom offered a response. As a result, four questions were resolved for two ingredients. However, for the remaining products, it was revealed that the manufacturers described in the product information summaries what they claimed at the time of submission even though their claims were not accepted by PMDA.<br><b>Conclusion: </b>It was considered that the pharmaceutical manufacturers possibly did not comprehend the contents of the PMDA’s evaluation reports. It was suggested that the industry as a whole should examine the issue. As discrepancies were observed even in product information summaries, which are viewed by a relatively large number of people, it was assumed that more issues may be found in promotional materials provided exclusively to healthcare professionals.
