Pharmacy Times, Volume 0, 0

Branded drug makers fired back atcritics of their use of "authorized generics,"citing new research findings thatshow no evidence that this strategydelays the onset of generic competition.The study, conducted by researchers atthe Massachusetts Institute of Technology's(MIT) School of Management,suggest that, if anything, the introductionof authorized generics during the180-day exclusivity period awarded tothe first generic company that challengesa brand drug's patent actuallybenefits patients by lowering the cost ofmedication.

The MIT research was backed by thePharmaceutical Research and Manufacturersof America (PhRMA). The association'smembers have been accusedof using authorized generics as a ploy todiscourage generic manufacturers fromintroducing low-cost alternatives todrugs as they lose patent protection."This study and others show thatauthorized generics are increasing competitionand helping lower prescriptiondrug prices for patients, not harmingcompetition,"a PhRMA spokespersonsaid. "As a result, proposals to restrictauthorized generics would reduce consumersavings."

Officials at the Generic PharmaceuticalAssociation (GPhA), however,called the study "a disingenuousattempt to devalue the 180-day exclusivityperiod, which is an importantincentive for generic pharmaceuticalcompanies to challenge questionablepatents and bring affordable medicinesto market."According to GPhA, thebranded drug industry "is simply focusedon abusing every loophole it can find insearch of greater profits and to maintaina brand name drug monopoly."