FDA's response to clarion calls in Congress for drug safety legislation and the Institute of Medicine's laundry list of drug safety reforms has been muted, but the agency plans to take the bull by the horns next month. In December, it will announce the findings of an intensive internal review of the IOM report and release a PDUFA IV proposal that incorporates lifecycle safety management principles. Taken together, the two initiatives are intended to convince Congress to allow FDA to put its house in order.
As in previous iterations of PDUFA, the regulators will ask industry for more money and in return regulated industry hopes to inject more accountability, predictability and transparency in the oversight process.
But in a major departure from precedent, industry has largely abandoned the requirement that its money be narrowly focused on approvals, consenting to the allocation of user fees for a broad range of activities. These include reviewing the safety of approved drugs, regardless of how long they have been on the market,boosting FDA's information technology infrastructure, and funding research on social science topics that are not linked to specific reviews.
The agreement is intended to lay the groundwork for FDA to shift from a passive to an active post-market surveillance posture.
It also reinforces FDA's pre-approval authorities. The agency is committing to adhere to timetables for pre-approval risk management and labeling discussions so sponsors are not presented with last-minute take-it-or-leave-it choices on issues of great importance to