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.”
From the January 01, 2012 Issue of MM+M - Medical Marketing and Media
