Pharmaceutical Company Payments to Japanese Government Drug Regulation Committee Members.

Abstract

Little is known about the characteristics and distribution of financial conflicts of interest (FCOIs) in the drug regulation process, both in Japan and globally. This study aimed to identify the characteristics and distribution of pharmaceutical payments to members of Japanese government drug regulation committees, and to assess the accuracy of their FCOI statements. Among members who worked for either of the five committees of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), which is the advisory committee for pharmaceutical affairs in Japan, from April 1, 2017 to March 31, 2019, the extent of payments in 2016 from 78 major pharmaceutical companies in Japan and the accuracy of the self-reported FCOI disclosures were assessed. Of 108 members, 54 (50%) were medical doctors. The payments to the PAFSC members totaled ¥115,765,006 ($1,064,017), and the mean (SD) payment was ¥1,071,898 ($9,852) (¥2,272,520 ($20,887)). Fifty-one members (47%) received at least one payment from a pharmaceutical company in 2016; 32 members (30%) received more than ¥500,000 ($4,600). Of 8,530 declarations from five councils, 409 (4.8%) of the FCOIs self-reported by the committee members were inaccurate. Of those inaccurate disclosures, 112 of 409 inaccurate disclosures (27.4%) would have prevented the recipients from participating in the drug-approval decision-making processes had they been correctly disclosed. Almost half of drug regulation committee members in Japan received at least one payment from pharmaceutical companies in 2016. Moreover, several FCOIs they reported were inaccurate.