GPhA challenges authorized generics study

August 21, 2006

GPhA has announced the results of an independent study that disputes a recent PhRMA report endorsing the use of authorized generics. The new study, An Assessment of Authorized Generics: Consumer Effects and Policy Issues, by Aidan Hollis, M.D., and Bryan A. Liang, M.D., concluded that the practice of authorizing generics significantly reduces incentives for independent generic firms to challenge invalid brand-name patents and develop non-infringing processes.

GPhA challenges authorized generics study

GPhA has announced the results of an independent study that disputes a recent PhRMA report endorsing the use of authorized generics. The new study, An Assessment of Authorized Generics: Consumer Effects and Policy Issues, by Aidan Hollis, M.D., and Bryan A. Liang, M.D., concluded that the practice of authorizing generics significantly reduces incentives for independent generic firms to challenge invalid brand-name patents and develop non-infringing processes. The authors raised several concerns about the methodology used in the PhRMA study. Hollis and Liang contend that factors such as an inconsistent choice of data, inadequate data points, and the use of wholesale, instead of retail, prices resulted in significant problems with the PhRMA study. "We used retail prices because we wanted to look at consumer benefits," said Liang at a press conference. Kathleen Jaeger, president/CEO of GPhA, said the association would aggressively pursue a legislative "fix" in order to address the issue of authorized generics.

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