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Executive Summary

FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS UNDER FDA REVIEW and will be the subject of an FDA-sponsored open public hearing in 1993. Through the hearing, the agency expects to gather information from the drug and device industries and the scientific community on what the requirements should be for disclosure of investigators' financial interests in drug products and companies, FDA Deputy Commissioner for External Affairs Carol Scheman told a Dec. 9 session of the Food and Drug Law Institute's annual meeting in Washington, D.C. Scheman said she hopes to "hold some sort of formal open hearing to get information; we need to find out what's actually happening [and] how companies feel about this issue." She noted that "one of the questions that I so far have not found an answer to is: do companies...ask questions of that investigator about that investigator's financial interest in a competitor?" Other issues the agency would like hear about are whether investigators own stock in a firm they are working for and whether start-up firms have equity relationships with investigators. The deputy commissioner is chairing an FDA task force that plans to develop a series of recommendations for the agency to deal with financial disclosure requirements for clinical investigators. The task force, which has been meeting for several months, was put together in response to an Office of the Inspector General's report that said FDA's lack of a policy in this area was a material weakness. The group consists of representatives from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the general counsel's office and the ombudsman's office. The task force is in the process of finalizing a statement of issues and a series of questions that FDA needs to understand to formulate its policy. These documents will be presented to Commissioner Kessler at the end of December and may be published as an advanced notice of rulemaking. Scheman told FDLI that FDA is "looking rather seriously to find out what other actors there are...that can also take responsibility for" financial disclosure by clinical trial investigators. She noted that the National Institutes of Health and the National Science Foundation have proposals dealing with financial disclosure in circulation. NIH has an unpublished proposed rule that will probably require investigators and other key personnel involved in NIH- funded research to disclose certain outside interests before a grant award is made and annually thereafter. NIH also may prohibit investigators of drug trials from having any financial relationship with a business whose product is being tested. NSF's proposed regulation, issued in July, says that grant applications must submit full disclosure reports to NSF detailing financial ties that either the investigator or his immediate family and close associates have that could potentially affect the proposed research. Scheman noted that FDA's role in financial disclosure requirements is different from NIH and NSF, because FDA, unlike those institutions, does not issue grants to investigators. However, FDA is concerned about and does monitor the integrity of clinical data submitted to the agency. FDA wants to clarify what its role is in disclosure requirements, Scheman said.

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