FDA Seeks $4.5B in 2013 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.

The US FDA 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.

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