- Resource Centers
Branded drug makers fired back at critics of their use of "authorized generics," citing new research findings that show no evidence that this strategy delays the onset of generic competition. The study, conducted by researchers at the Massachusetts Institute of Technology's (MIT) School of Management, suggest that, if anything, the introduction of authorized generics during the 180-day exclusivity period awarded to the first generic company that challenges a brand drug's patent actually benefits patients by lowering the cost of medication.
The MIT research was backed by the Pharmaceutical Research and Manufacturers of America (PhRMA). The association's members have been accused of using authorized generics as a ploy to discourage generic manufacturers from introducing low-cost alternatives to drugs as they lose patent protection. "This study and others show that authorized generics are increasing competition and helping lower prescription drug prices for patients, not harming competition,"a PhRMA spokesperson said. "As a result, proposals to restrict authorized generics would reduce consumer savings."
Officials at the Generic Pharmaceutical Association (GPhA), however, called the study "a disingenuous attempt to devalue the 180-day exclusivity period, which is an important incentive for generic pharmaceutical companies to challenge questionable patents and bring affordable medicines to market."According to GPhA, the branded drug industry "is simply focused on abusing every loophole it can find in search of greater profits and to maintain a brand name drug monopoly."