The “Program” At Half-Time: Report Finds Happy Sponsors, But Tweaks Suggested
This article was originally published in RPM Report
Drug sponsors are enthusiastic about FDA’s new review “Program” for novel drug and biologic applications. But they also want to see some tweaks to make the review process even more efficient – ideas that are sure to be brought to the PDUFA VI negotiating table. One trouble spot FDA says will be addressed right away: manufacturing facility inspections for Program applications.
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FDA completed a major reorganization of the way it regulates manufacturing quality of drugs and biologics with the launch of the Office of Pharmaceutical Quality within the Center for Drugs. OPQ is part of Janet Woodcock’s decade-long effort to ensure a consistent, safe drug supply. The immediate impact on industry will be minimal, but manufacturers that haven’t invested in facility upgrades will face a steep learning curve.
Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.
Industry came to the PDUFA V negotiating table with one big agenda item: improved communication with FDA officials about a product under review. They succeeded, but it came with a price: an extra two months for FDA to review an application. While it may seem like things just went back to 2002, both industry and the agency say it could actually lead to faster approvals.