FDA requests 17% increase in 2013 budget

Published: 14-Feb-2012

Aims to enhance drug safety, advance medical countermeasures and improve trade with China


The US Food and Drug Administration has requested a $4.5bn budget, an increase of 17% over 2012, in President Obama’s US$3.8 trillion 2013 federal budget.

In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA budget also contains increased funding ($1.7bn) to improve the safety of drugs and other medical products, advance medical countermeasures and facilitate greater trade with China by improving the safety of imports to the US.

‘These are austere budget times, and the FDA budget request reflects this reality,’ said Margaret Hamburg, the FDA’s commissioner of food and drugs.

‘Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalisation and allow the FDA to fulfill its public health duties more efficiently.’

The Protecting Patients Initiative (+$364m) recommends new user fees to support FDA generic drug activities ($299m) and to support development and review of biosimilar biological products ($20m).

The initiative also includes resources ($62m) to equip the state-of-the-art Life Sciences Biodefense Laboratory at the FDA’s White Oak, Maryland campus.

The Transforming Food Safety and Protecting Patients Initiatives include $10m in new resources for the FDA to enhance collaboration with its Chinese counterparts and increase its presence in and expertise on China. This investment will strengthen the safety of the food and drugs produced in China for export to the US.

The Medical Countermeasures (MCM) Initiative (+$3.5m) will help meet America’s national security and public health requirements for MCM readiness.

Congress provided new resources in FY 2012 of US$20m to support the FDA’s role in protecting the US from chemical, biological, radiological and nuclear threats, and from emerging infectious diseases such as pandemic influenza. An additional $4m in FY 2013 will support science and partnerships to improve MCM development timelines and the success rates for MCMs.

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