Graben, Roger Kowa Pharmaceuticals America, Inc. AL

By defining the "applicable manufacturer" as any entity under common ownership, undue burden is placed upon industry to collect and submit data. Global companies may have numerous companies under common ownership, and coordination and submission is not practical. This is further compounded by adding the requirement to report for "non-covered" drugs as well. Global companies may pay physicians to perform research on numerous drugs which never reach the market or may never be intended for the US market. This and the general concept for reporting for drugs under development only encourages companies to conduct all possible research outside the US, which undermines both the US economy, and reduces the amount of data collected on subjects in the US. The goal should be to make clear payments made to prescribers and teaching hospitals related to drugs prescibed by these practioners and in these hospitals and reimburded by CMS and other payers. Payments related to drugs in development and by all companies under common ownership reach beyond this goal. No doubt the argument can be made that these non-reported expenses could be a way to funnel unseen payments to prescribers. In this scenario, a company would be actively seeking to behave in a fradulent manner. No amount of unduly cumbersome regulation can prevent those seeking to commit fraud from doing so. The regulations should be such that ethical companies can make all relevant payments transparent in a manner that is not unduly cumbersome to collect and report. The reporting for "all entiities under common owner", the reporting for "non-covered drugs" and the reporting of "all developmet expenses" all reach beyond the sciope and purpose and create undue hardship on industry.