It is clear to Big Pharma that Obama's biosimilars plan threatens the American Pharma's Way of Life, Liberty and Pursuit of Happiness. The new plan to stop "pay for delay" and cut exclusivity by 5 years will threaten innovation and jobs.
The plan is designed to cut the $1.1 trillion Federal deficit over the next 10 years. Obviously the two provisions mentioned above are intended to make generics/biosimilars more available earlier and result in reduced governement expenditures of medications. The White House says it can save $12 B over the 10 years (by itself not much dent in the $1.1 trillion deficit I might add).
PhRMA's President and chief executive, John Castellani said, "The proposed legislation could jeopardize American competitiveness since the US would then provide less data protectin for new, innovative biologics than is currently being bestowed in Europe [proposed 7 years in US vs. 10 years in Europe]".
Time for PhRMA to bargain reasonably around the exclusivity provisions in exchange for policies to promote growth of private-sector R&D investment in US biotechnology and medical innovation.
Posted by Bruce Lehr Feb 18th 2011.