On Monday FDA released a $4.5 billion budget request for 2013, which represents a 17% (or $654 million) increase over its current budget.  The request, which is part of the White House’s $3.8 trillion federal budget proposal, includes a dramatic increase in industry user fees.  In fact, FDA Commissioner Margaret Hamburg says nearly 40% of the new budget will be derived from both reauthorized and newly-implemented fees to industry users, according to.a DOTmed report.

In October of this year, the two current user fees for medical devices and drugs are expected to be renewed.  In addition, FDA’s proposal calls for the implementation of seven new industry user fees—these include a $20 million fee for biosimilars and a $299 million fee to support generic drugs.  All things considered, the increase in proposed user fees accounts for 98% of the total proposed FDA budget increase, while the $2.5 billion requested from Congress remains virtually the same as last year.

“User fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion,” said Hamburg, who went on to explain, “[these] fees have revolutionized the drug review process in the United States since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards.”  Hamburg explained her thoughts further in a FDA Voice blog.

Pearl Pathways’ clients striving to develop drugs, devices, and other products subject to regulatory approval are sure to be hit by FDA’s renewed push to support the regulatory review process through increased industry user fees.  But an expanded budget promises to enhance the efficiency of an otherwise-sluggish review process for these products.  To read FDA’s budget request news release, click here.