Some PDUFA firsts
Be afraid. Be very afraid. The PDUFA Reauthorization Bill gives the FDA authority never before enjoyed.
At Wednesday's session "Drug Safety and PDUFA IV: Overview of Critical Issues in Congress", BIO's VP for government relations, Brent Del Monte, outlined a few "concerns" (his word) with the legislation (Senate Bill S.1082). Consider: this is the first time that economics is entering an equation (Historically the FDA has been concerned with safety and efficacy). A provision of PDUFA IV limits the period of market exclusivity of certain drugs to three months when sales exceed $1 billion. This is also the first time, according to Del Monte, that Congress is going in and making changes to the agreement. And the first time that user fees have been increased by Congress, which, by the way, under the new legislation will account for 70% of the FDA budget for drug approvals -- up from 50%.
But on the plus side, an amendment allowing the sale of baby turtles treated with proven methods for Salmonell has been introduced. Don't ask me why.
