FDA Publishes Draft Guidance on Financial Disclosures by Clinical Investigators
FDA has released for public comment a draft guidance document entitled “Financial Disclosures by Clinical Investigators.” The guidance, which will supersede March 2001 guidance on this issue, seeks to respond to a January 2009 HHS Office of the Inspector General (OIG) report that concluded that clinical investigators may not be disclosing all financial interests (). It also addresses questions FDA has received from industry and the public. The draft guidance describes: (1) the sponsor’s responsibility to collect the financial disclosure information prior to an investigator participating in a study and ensure that all required forms and attachments are submitted in marketing applications; (2) what is meant by ‘‘due diligence’’ in obtaining financial disclosures from investigators; and (3) how FDA will review financial disclosure information. The guidance also solicits comment on the circumstances under which FDA should consider public release of financial disclosure information related to an approved marketing application. FDA is accepting comments on the draft guidance until July 25, 2011.
