Bad news for authorized generics on two fronts.
First, a Generic Pharmaceutical Association (GPhA) study showed that authorized generics yield consumers few cost savings, and that any such savings come from higher brand product prices, not lower generic prices.
And second, three Democratic senators announced a bill to ban them outright.
The GPhA study concluded that when authorized generics are marketed during a 180-day exclusivity period for an independent generic company, they significantly reduce the incentives for independent generic firms to challenge brand-name patents and develop non-infringing processes.
The findings challenged the methodology, analysis and conclusions of a recent study by the Pharmaceutical Research and Manufacturers of America that reported discounts off brand prices up to 15.8% greater in markets with authorized generics than in those without them.
Meanwhile, Senate bill S. 3695 was introduced to ban “authorized generics” from launching during the first approved generic applicant’s 180-day marketing exclusivity period. Backed by Senators John D. Rockefeller IV (D-WV), Charles Schumer (D-NY) and Patrick Leahy (D-VT), the measure is intended to prevent brand drug makers from re-packaging previously approved drugs as generics in an attempt to undermine generic competition.
“Authorized generics are a sham,” said Rockefeller. “They are nothing more than repackaged prescription drugs without true generic’s lower cost,” and eliminate billions in prescription drug savings.