FDAnews Drug Daily Bulletin

GPhA: House Held No Joint Stakeholder Meeting Before Nixing REMS Provision
Generic-drug makers are raising concerns with their access to House user fee bill negotiations because unlike the Senate, House lawmakers didn’t hold a joint meeting with the FDA, PhRMA and the Generic Pharmaceutical Association (GPhA) on certain cost-saving provisions of its FDA user fee bill. GPhA did not have a chance to voice its concerns to House leaders before they decided to exclude a cost-saving measure that would have helped generic makers develop follow-ons for certain restricted-access drugs.
Drug Industry Daily