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Commissioner McClellan’s First FDA Appropriations Hearing, In Brief

Executive Summary

Generic drug rule: FDA expects to finalize proposed changes to Waxman/Hatch patent challenge procedures by spring, Commissioner McClellan tells House Appropriations/Agriculture Subcommittee hearing March 6. President Bush announced the rule in October (1"The Pink Sheet" Oct. 28, 2002, p. 3)....Generic drug education: "Let me ask you about the issue of doctors not really knowing the costs of prescription medications and what a patient might have to pay out of pocket for that drug," Rep. Jo Ann Emerson (R-Mo.) said. "If we were to make necessary funds available would you all consider expanding the current generic drug education program to target medical schools or teaching hospitals?" McClellan responded: "That would be something we could do with additional funds." Last year, FDA launched an educational campaign to encourage the use of generics (2"The Pink Sheet" July 29, 2002, p. 21)...

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