Generic drug user fees totaling $38 million are included in US President Barack Obama's proposed budget for fiscal 2011, announced yesterday.

The user fees - for which new legislation would have to be created - plus a $2 million increase in taxpayer funding, would be used to improve review times and reduce the current backlog of applications for generic drug approvals at the Food and Drug Administration (FDA), in order to “bring more safe, effective and lower cost generic drugs and generic biologics to market,” say budget documents.

“Generic drugs play an important role in reducing the cost of and increasing access to pharmaceuticals,” they add. Pres Obama first tried to introduce generic user fees in his fiscal 2010 budget, but that proposal foundered in Congress.

The budget proposal also includes a request for $51.5 million funding for the FDA Office of Generic Drugs (OGD), an increase of $10 million over last year’s budget request. This has been welcomed by Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), who described it as “a meaningful step towards enhancing FDA's Generic Drugs Program."

The FDA’s total requested budget would increase by 23% in fiscal 2010 - which runs October 1 2010 to September 2011 - to $4.03 billion, including user fees, and this would “strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” said FDA Commissioner Margaret Hamburg. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences,” she added.

The budget of the National Institutes of Health (NIH) would rise $1 billion to $32 billion and, according to the budget documents: “to accelerate progress in biomedical research, NIH investments will focus on priority areas including genomics, translational research, science to support health care reform, global health, and reinvigorating the biomedical research community.”

Other health-related budget requests include $286 million the Agency for Healthcare Research and Quality (AHRQ), which will conduct for comparative effectiveness research, and $25.5 billion over six months for states to help them with costs related to Medicaid, the federal-state health insurance programme for the poor.