Researchers led by Duke University professor emeritus of economics Henry Grabowski are urging Congress, in a PhRMA-sponsored study, to extend the exclusivity period for branded drugs by seven years and remove the initial 180-day marketing exclusivity granted to first-to-file generics by the 1984 Waxman-Hatch Amendments.
In a Health Affairs article. they propose that the legislation be re-evaluated in light of its intended purpose: balancing incentives for generics with innovation.
Their report analyzes data from 1995 to 2008 and finds that the average period of “market exclusivity” has dropped. In addition, Paragraph 4 certification challenges have increased and are occurring sooner after reference-listed drug launch.
A sharply negative response from the Generic Pharmaceutical Association (GPhA) claimed that implementing such “reckless recommendations” would gut the Waxman-Hatch Act, costing consumers and the U.S. health system as much as $1 trillion over the next decade. “Indeed,” the release said, the proposals “would put at risk not only the sustainability of the American healthcare system, but also the national economy.”