New Financial Disclosure Guidelines From FDA

If you own shares in a mutual fund that includes a company for whom you are a clinical investigator for an FDA-sponsored investigation, do you have to disclose that? Can a literature report be considered a covered clinical study?

The FDA’s got the answers for you in a new guidance.

The “Guidance for Clinical Investigators, Industry, and FDA Staff – Financial Disclosure by Clinical Investigators, ” was issued in February and is a revision of 2001 guidance.

Applicants who submit a marketing application for a drug, biological product or device are required to submit certain information concerning the compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies. This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. They must certify the absence of certain financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to FDA, or to disclose those financial interests and arrangements to the agency and identify steps taken to minimize the potential for bias

The FDA issued a revised guidance in draft form in May 2011 for public comment. Comments were received from 13 individuals and entities, which were considered in preparing this final guidance.

Financial disclosure requirements go back to June 1991, when the Inspector General of the Department of Health and Human Services submitted a management advisory report to the FDA stating that FDA’s failure to have a mechanism for collecting information on “financial conflicts of interest” of clinical investigators who study products that undergo FDA review could constitute a material weakness under the Federal Managers’ Financial Integrity Act.

To get your copy of the 35 page guidance document, click here.