European Fine Chemicals Group ratifies US FDA's proposed Generic Drug User Fees Act

The board of the European Fine Chemicals Group (EFCG) says that it has agreed to ratify the proposal of the US Food and Drug Administration to put forward a legislative package, designed with the help of EFCG and US industry representatives, to deliver into US law a new Generic Drug User Fees Act (GDUFA).

GDUFA requires the FDA to commit to significantly improve and enhance its regulatory activities for the benefit of global generic drug providers and US generic drug users, in exchange for the global generics industry providing FDA with $299 million in user fees each year over the next five years, which was agreed last month. The research-based pharmaceutical industry recently agreed to a 6% increase in user fees as part of moves to reauthorize the Prescription Drug User Fee Act (The Pharma Letter September 5).

Some of the points for further negotiation between the relevant parties included: