New FDA Draft Guidance Regarding Financial Disclosures by Clinical Investigators


New recommendations recently released by the FDA demonstrate the changing environment for conflicts of interest management and emphasize the need for pharmaceutical companies, medical device manufacturers and health care providers to ensure they have internal processes that adequately anticipate and meet the baseline requirements.

On May 25, 2011, the U.S. Food and Drug Administration (FDA) released a new draft guidance entitled Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (Draft Guidance). Comments regarding this Draft Guidance are due to the FDA no later than July 25, 2011.

Though the Draft Guidance is not the final statement of the FDA’s position on this topic, it provides an opportunity for the pharmaceutical and device industry, health care providers and institutions to evaluate their current conflict of interest programs and consider modifications to align their programs with these new anticipated standards. The Draft Guidance would revise and replace the FDA’s 2001 publication, Guidance for Industry: Financial Disclosure by Clinical Investigators (the 2001 Guidance). The issuance of the Draft Guidance by the FDA suggests that the agency will be scrutinizing more closely investigator and institutional compliance in the management of conflicts of interest. In addition, the Draft Guidance clearly anticipates that investigators, institutions and industry will take meaningful and coordinated steps to implement the FDA’s regulations, and such compliance may require a substantive, thorough and deliberative process that exceeds the simple administrative exercise of collecting forms.

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