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.
Most of the important elements in the PDUFA package were finalized last summer, including the creation of a new system to use health system databases to monitor real-world safety and efficacy of drugs and medical devices, granting FDA new authorities to mandate label changes and postmarket studies, and increased transparency of agency approvals as well as clinical research (see "The New Mandates," A2).
As expected, industry agreed to give the agency boatloads of money. The law, which President Bush is expected to sign this week, includes $225 million in user fees over five years above the amount agreed between FDA and industry last year. The additional fees, which will be used to fund drug safety programs, could bring the proportion of FDA drug oversight paid by industry to 80% by 2012, assuming minimal increases in taxpayer funding.
In addition to diluting FDA preemption over state law, which pharmaceutical industry lobbyists were unable to excise, FDAAA will generate large amounts of safety data that will certainly provide more grist for the tort lawyers' mills. Nevertheless,