A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States. Issue 5 (18th February 2021)

• Record Type: Journal Article
• Authors: Hoshino, Yuko; Narukawa, Mamoru
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 30:Issue 5(2021)
• Page Start: 561
• Page End: 572
• Publication Date: 2021-02-18
• Subjects: adverse drug reaction -- FDA -- labeling -- pharmacoepidemiology -- pharmacovigilance -- PMDA -- safety‐related regulatory action; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.5203
• Languages: English
• ISSNs: 1053-8569

Abstract

Abstract: Purpose: It is important to make the most up‐to‐date drug safety information available to the public in a timely manner so that health care professionals and patients can consider the information. The aim of the present study was to investigate the consistency and simultaneity of safety related updates in product labeling in Japan and the United States. Methods: New safety label changes that were made for new drugs approved concurrently both in Japan and the United States in the recent 5 years were identified and reviewed for concordance and time lag analysis. Factors associated with the time lag were also investigated. Results: Despite similar medical practices, population health and regulation in the countries, a low level of concordance (40/115, 34.8%) in the decision of labeling change was found in 31 new active substances. Only 3/40 (7.5%) of the concordant changes were made simultaneously. Labeling change orders issued by regulators and domestic postmarketing adverse event reports were associated with a significant difference in the timing of labeling change between the countries. Conclusions: We found a low level of concordance between regulators in the decision of labeling changes and the timeliness of the changes. The low concordance and time lag highlighted the need for further international collaboration between regulators and industry and greater transparency in the decision‐making process for the label change.