President Obama's fiscal 2011 budget will add a modest $1.7 billion to the Department of Health and Human Services budget if it's passed, bringing the department's total budget to $81.3 billion. At the National Institutes of Health, the administration wants to support expanded biomedical research by giving the agency $32.1 billion in 2011, up from $30.8 billion in fiscal 2010. Its goal is to get 30 new drug trials initiated in 2011 and double the number of novel compounds in early to late stage clinical trials by 2016.

 

Additionally, the White House would like to support the completion of "a comprehensive catalog of cancer mutations for the 20 most common malignancies, setting the stage for complete genomic characterization of every cancer as part of medical care within 10 years," it says.

 

The budget also includes a proposed six percent bump for the Food and Drug Administration, raising its budget authority to $2.5 billion with $4 billion in total program resources, including user fees. Among other goals, the increase is aimed at helping the agency bring "more safe, effective, and lower cost generic drugs and generic biologics to market," while simultaneously expanding postmarket safety surveillance of medical products and patient access to safety data.

 

New user fees, generally meant to help the FDA defray its expenses, are the talk of the industry following the budget proposal's release. The new charges would support streamlined review for generic drugs, something that companies in the space support.

 

“The generic pharmaceutical industry remains open to a generic user fee program,” says Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association.

 

There would also be new user fees attached to follow-on biologics that would apply once Congress finally hammers out a legal framework for their approval.