Many observers have believed the U.S. Congress would approve a regulatory process this year for generic biologic medicines… But proposals to address the weak U.S. economy are consuming the legislative agenda and pushing down other issues on the priority list, [Bruce] Downey, [former CEO of Barr] said.
"I think it's probably unlikely given the agenda that the Congress has that you'll see generic biologic legislation this year," Downey said. "It's possible, but I think the probability is declining. I think it's very high that you'll see it in 2010."
I must concur with Downey. First, Downey is the leading authority anywhere on the subject and, second, it’s plain to see that Congress is consumed with matters pertaining to the credit crisis and the transition to a new administration.
Notably, Teva’s head of US operations, Bill Marth, predicts FoB legislation in 2009. However, Marth has an axe to grind and Downey doesn’t.