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FDA CONFLICT OF INTEREST SEMINARS TO BE CONDUCTED FOR ALL DIVISIONS

Executive Summary

FDA CONFLICT OF INTEREST SEMINARS TO BE CONDUCTED FOR ALL DIVISIONS by the Division of Ethics and Program Integrity beginning Nov. 1, according to division Director Delores Willis. The pilot program of Conflict of Interest Awareness Training, scheduled over the next six months, is intended to familiarize the nearly 7,000 FDA employees with government standards of ethical conduct. According to Willis, the seminars will occur three to four times a month for the first six months, lasting two-and-a-half hours each, with groups of 12-15 staffers per seminar. If successful, the program will be extended over a period of two to three years. Eventually the division expects to institutionalize the program, Willis said, to keep FDA staff updated on new regulations. The conflict of interest seminars will begin with the Division of Generic Drugs, where staff will attend sessions on Nov. 1 and Nov. 9. The Generics division is currently the subject of a congressional subcommittee investigation for allegations of favoritism in ANDA approvals. An agenda from the Nov. 1 session includes a viewing of the Ethic's Division video "Public Service-Public Trust", a presentation of the government-wide ethics program, an overview of Department of Health and Human Services standards of conduct, an overview of FDA regulation and case study workshops. One case study from the Nov. 1 session poses the problem: "One night you are having dinner with an old college friend who is the plant manager of an FDA- regulated firm. At dinner he mentions to you that there is a vacancy in the plant's management and he thinks that you would be a good candidate for the job. He says that if you are interested he will set up a meeting with the plant president. What should you do if (1) you are interested? (2) you are not interested? (3) you would like to think about it for a few days?" Previously, employees have attended, as part of their training, courses covering some conflict of interest issues. Employees must also make annual financial disclosures to keep the agency abreast of any investment involving a possible conflict of interest. Upcoming seminars will be held on Nov. 9 at the Parklawn building, and Nov. 8 and 9 at FDA's Center for Food Safety office in Washington. The first FDA district office to receive the training was New Orleans (Nov. 3).
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