States' rights trump FDA

Last minute horse-trading over PDUFA reauthorization legislation slashed the size of monetary penalties FDA can impose for violating terms of risk management plans, swept off the table a proposal to reduce the value of incentives for conducting pediatric research on blockbuster drugs, and deleted a plan to place a warning symbol on the labels of all drugs for two years after approval.

But if the drug industry's critics ceded ground on those ideas, they did not budge on keeping the door open to product liability suits, ramming home an 11th hour provision in the FDA Amendments Act of 2007 (H.R. 3580, FDAAA) that is intended to eliminate the federal preemption defense against state liability litigation...