FDA wants $15.7 in generic user fees

March 5, 2007

The FDA has asked Congress to allow the agency to collect user fees for each new generic drug application (ANDA) and annual fees for all approved generics. The user fees are intended to generate additional resources?money and manpower?to allow the FDA to reduce the time it takes to review and respond to the growing number of generic applications. The estimated user-fee collections for generics would total more than $15 million. Current law prohibits the FDA from collecting user fees for generics approved under the ANDA process. GPhA president/CEO Kathleen Jaeger said that the decision to include user fees in the 2008 budget would not bring generics to consumers faster. "If the Administration's goal is to get safe, effective, and affordable generics to consumers faster, then it must work with Congress to remove existing barriers that are delaying access to generics and increasing healthcare costs." In contrast, the Academy of Managed Care Pharmacy supports the expansion of the FDA's authority and funding through user fees. AMCP officials cited problems associated with drugs that are identified after a drug has been in use by a broader population. The organization endorses postmarket surveillance studies, claiming they are essential to protect the public health. To see more Hot off the Press news articles, click here. To go to the Drug Topics homepage, click here.

The FDA has asked Congress to allow the agency to collect user fees for each new generic drug application (ANDA) and annual fees for all approved generics. The user fees are intended to generate additional resources?money and manpower?to allow the FDA to reduce the time it takes to review and respond to the growing number of generic applications. The estimated user-fee collections for generics would total more than $15 million. Current law prohibits the FDA from collecting user fees for generics approved under the ANDA process. GPhA president/CEO Kathleen Jaeger said that the decision to include user fees in the 2008 budget would not bring generics to consumers faster. "If the Administration's goal is to get safe, effective, and affordable generics to consumers faster, then it must work with Congress to remove existing barriers that are delaying access to generics and increasing healthcare costs." In contrast, the Academy of Managed Care Pharmacy supports the expansion of the FDA's authority and funding through user fees. AMCP officials cited problems associated with drugs that are identified after a drug has been in use by a broader population. The organization endorses postmarket surveillance studies, claiming they are essential to protect the public health. To see more Hot off the Press news articles, click here. To go to the Drug Topics homepage, click here.