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USP TRAVEL SUPPORT FOR FDA EMPLOYEES IS EXEMPT FROM RESTRICTION

Executive Summary

USP TRAVEL SUPPORT FOR FDA EMPLOYEES IS EXEMPT FROM RESTRICTION set forth by the agency last month to limit "in kind" travel contributions from outside groups, FDA Associate Commissioner for Management Operations Sharon Smith Holston told the organization in a July 31 letter. "If USP (United States Pharmacopeial Convention) offers to pay the costs of employee travel to participate in the Committee of Revisions or USP advisory panels," Holston said, "we would not generally find any impropriety in accepting such an offer." The agency's travel policy, outlined in a July 6 memo, was created after an investigation into the generic drugs division revealed that travel expenses for FDA employees attending National Association of Pharmaceutical Manufacturers' annual meetings had been subsidized by the association. The guidelines forbid agency employees from accepting "in kind" contributions, such as travel expenses, lodging, or meals, from outside organizations ("The Pink Sheet" July 17, p. 16). Holston wrote the letter in response to USP Executive Director William Heller's July 7 letter to Commissioner Young, in which he said USP is "fearful that adoption of a broad policy without sufficient consideration or exemption of USPC activities may have unintended deleterious effects," including strict limitations on FDA's ability to participate in USP committees and activities. Explaining the decision not to hold USP to the travel regulations, Holston stated that FDA employee participation in USP's Committee of Review Decisions is not viewed as "an outside activity for our employees -- we regard such activitesas a part of the employees' official duties, to the extent their participation furthers work that is important to FDA's mission." Accordingly, she continued, "when FDA employees participate on this committee, they do so in their offical capacity, and not in their personal capacity." Holston acknowledged that HHS conflict-of-interest regulations prohibit travel support from organizations in which the employee is "an officer, board member, trustee or employee"; however, Holston added, "we do not believe that an employee's service on your Committee of Revisions meets this description."
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