Proposed Fiscal 2006 Budget to Focus on FDA Drug Safety

President Bush's proposed fiscal 2006 budget would boost the FDA's drug safety efforts by an additional $6.5 million, giving the agency a total of $747 million for human drugs and biologics programs -- an overall increase of $26 million from fiscal 2005 levels.

Under the White House budget request, the FDA's Office of Drug Safety (ODS) would receive a total of $33 million in the next fiscal year, which starts Oct. 1. Of the additional $6.5 million in proposed funding, $1.5 million would come from industry under the Prescription Drug User Fee Act. The overall budget request for the FDA is $1.88 billion for fiscal 2006, an increase of $81 million over fiscal 2005.

The proposed increase for the ODS would be used to hire 25 new full-time equivalent employees, bringing total staffing in the ODS to 134 employees. The funds also would support greater FDA access to data on drug use, according to the agency. The FDA plans to increase spending to improve access to a range of clinical, pharmacy and administrative databases, according to the budget blueprint. "As each drug has its own indication(s) that may result in its differential use in different populations, it is essential that the Center for Drug Evaluation and Research have access to a wide range of databases to adequately assess drug safety," the FDA said.

The HHS budget request also calls for $600 million to ensure the effectiveness of the strategic national stockpile of medicines in the event of a major health emergency, including the detonation of a weapon of mass destruction. The $600 million would be used to buy additional drugs to replace old ones, as well as provide specialized storage and facilitate the delivery of needed medicines to any U.S. location within 12 hours.

The 605-page FDA budget is online at http://www.fda.gov/bbs/topics/news/2005/NEW01155.html (http://www.fda.gov/bbs/topics/news/2005/NEW01155.html). Details of the HHS budget are online at http://www.hhs.gov/budget/docbudget.htm (http://www.hhs.gov/budget/docbudget.htm).