The Generic Pharmaceutical Association (GPhA) is against "authorized generics" because they devalue the 180-day exclusivity requirements of the Hatch/Waxman Act that provide the incentive for generic pharmaceutical companies to challenge weak and questionable pharmaceutical patents. Successful patent challenges dramatically accelerate consumer access to affordable pharmaceuticals, according to the association.
"We urge the agency to maintain the spirit and intent of the 180-day exclusivity period which was strengthened in last year's Medicare reform bill," said Kathleen Jaeger, GPhA president and chief executive officer. "Authorized generics devalue the 180-day exclusivity period by destroying the incentive for generic companies to challenge patents, which, when the generic company is successful, creates competition and lowers drug costs. Preservation of the 180-day exclusivity incentive remains GPhA's top priority. We will continue to oppose efforts that undermine the economic incentive to challenge weak patents."