Quality & Compliance: FDA’s Financial Disclosure Regulations: Careful compliance in a Changing Landscape—Part II
Posted 01 December 2010 | By
This two part series reviews US Food and Drug Administration (FDA) financial disclosure regulations set forth in 21 CFR Part 54. Part I, published in the November issue of Regulatory Focus, presented the general requirements of the FDA financial disclosure regulations and actions the agency may take. It also discussed the challenges many sponsors face in interpreting the regulatory requirements relating to "significant payments of other sorts", or SPOOS. This article delves further into SPOOS to investigators' institutions using the scenario of a knee study sponsor with an investigator who is a knee surgeon in a large institution's orthopedics department. It then reviews the three other types of financial arrangements covered by the regulations: outcome-dependent compensation, proprietary interests in the product and equity interests in the sponsor. The article also discusses the changing landscape within and outside FDA regarding transparency of financial interests, and concludes with proactive steps companies can take to help stay under the radar.