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Authorized generics reg coming soon

Executive Summary

CMS plans to issue a proposed reg in the near future on the inclusion of authorized generics in Medicaid "best price" as required by the Deficit Reduction Act, Administrator Mark McClellan tells the Generic Pharmaceutical Association's Annual Policy Conference Sept. 20. However, considering FTC's study on the economic impacts of authorized generic is due out in 2007, McClellan says that CMS would "still value [FTC's] opinion before putting out a final rule." The outgoing Administrator also says CMS will release its revised definition of average manufacturer price this fall. CMS expressed dissatisfaction with HHS IG's lack of detailed guidance in its recommendations for the calculation of the benchmark (1"The Pink Sheet" June 5, 2006, p. 23)...

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