President Recommends FY 2009 FDA Budget
President Bush recommended a fiscal year 2009 budget for the U.S. Food and Drug Administration (FDA) of $2.4 billion. That figure is more than a five percent increase over the current year’s budget, as described in the press release from the Health and Human Services Agency.
Funds that comprise the forthcoming budget include user fees, paid by device and pharmaceutical manufacturers as their products undergo FDA review. The budget amounts to $1.77 billion if those user fees are considered separately. The remaining $628 million is from industry user fees.
Funds included in the budget recommendation are earmarked for improving the safety of products approved by the FDA, including pharmaceuticals and devices, and speeding the approval process for generic therapies, as well as implementation of new programs under the FDA Amendments Act of 2007. Another component of the new budget includes opening a new field office for the FDA in China, part of a plan to improve food safety.
The Alliance for a Stronger FDA says that the funding level is too low and instead has recommended increasing the budget to $2.1 billion for 2009, according to a report on Device Link. The consortium suggests that the Bush recommendation will not keep pace with rising inflation costs.
Others note the increasing onus placed on the federal agency over the past twenty years while funding has not kept pace with these increasing roles. Without the necessary funding, the FDA will face challenges in achieving its primary mission, much less the additional responsibilities under the FDA Amendments passed in 2007.
Some note that the increased budget is a reaction to growing concern over the safety of pharmaceuticals, as well as food safety scares of recent years. As reported by Reuters, the Bush administration promised last winter to improve the safety of food products entering the U.S.
February 11, 2008 Related topics: Legal & legislative, Finance