'ACCELERATED LABEL REVISION' PROCESS PROPOSED
PhRMA wants to shorten the time it takes a pharmaceutical firm to revise a drug label with the FDA -- a proposal that comes as lawmakers are pushing legislation that would give the FDA authority to mandate labeling changes.
Complex emerging data may require careful review, analysis and interpretation before an appropriate labeling statement can be developed, noted PhRMA. The group said it would like to explore with the FDA the possibility of using the agency's proposed Drug Watch program as part of an "accelerated label revision process." A key element of the Drug Watch program, announced in February, is to post emerging drug-safety concerns before they have been fully vetted. PhRMA strongly opposes this initiative, claiming that releasing unsubstantiated safety information raises public policy and legal concerns.
Instead, PhRMA is seeking something of a compromise. "Where the complexity of the data and its interpretation indicate that a lengthy review process can be anticipated, a timeline could be established for continuing discussions," PhRMA said. But if a label change is not finalized at the end of this timeline, the FDA "would be free to use the Drug Watch website to disseminate the safety information while labeling discussions continue," the trade group added.
The FDA currently has to negotiate labeling changes with manufacturers. Both Democratic and Republican lawmakers have slammed the FDA on this point, noting it took the agency 14 months to negotiate FDA-recommended labeling changes for Merck's arthritis pain drug Vioxx (rofecoxib), which was withdrawn last fall after it was linked to increased risk of heart attacks and strokes.
PhRMA said its proposal would ensure not only that important new safety information is communicated in a timely manner, but that such information is robust, valid and useful. It also would give sponsors a meaningful opportunity for input, and ensures that approved labeling remains the primary means of disseminating safety information.