FDA Looks to Sell Drugmakers on Benefits of Generic User Fees

As the FDA begins its long-awaited attempt to create a system of user fees for generic drugs, the agency is looking to sell drugmakers on the program while, at the same time, warning of the consequences if it is not established. “An effective program negotiated between FDA and industry would reduce review times and make funding more flexible,” FDA Commissioner Margaret Hamburg said. “The fact is that no one benefits from a pending application queue of 2,000-plus products.”
Washington Drug Letter