US FDA Plans Financial Disclosure For Researchers

The US Food and Drug Administration has published proposals to require financial disclosure to be made for clinical investigators involved in studies leading to approvals for pharmaceuticals (including over-the-counter monograph submissions), devices and biological products.

Under the proposed rule on Financial Disclosure by Clinical Investigators, published recently in the Federal Register, the sponsor of the marketing application would be required to provide information about financial arrangements with investigators that could bias clinical studies to be included in an application. At present, says the agency, it "has no mechanism to learn of the presence of such financial arrangements."

The arrangements which particularly concern the FDA are those that give the investigator a stake in the study's outcome, such as a payment that would be larger in the event of a favorable result, an equity interest in the product, payment in the form of shares or stock options in the company, or payment in the form of royalties. Other interests of concern include substantial grants made for equipment, retainers or honoraria.