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FDA gets lift in Bush budget.

WASHINGTON -- A 24% increase in funding for the office of the Food and Drug Administration that monitors the safety of medications once they have arrived on the market has been proposed by the Bush administration. The plan comes at a time in which the agency has found itself under a barrage of charges that it fails to provide sufficient attention to the serious side effects of drugs.

The budget for 2006 seeks an increased of $6.5 million for the office of drug safety, money intended to hire 25 workers to bring the staff to a total of 134. Funds would also give the agency wider access to databases of pharmacies and health insurers to help the FDA monitor adverse events and medication errors.

Overall, President Bush is seeking $1.88 billion for the FDA, a 4.4% increase ($81 million) over this year.

The White House has sent the plan to Congress, members of which will determine final spending levels over the next several months. The proposed increase is for fiscal year 2006, which begins October 1.

The office of drug safety came under acute criticism late last year when a veteran scientist in that office complained that his supervisors ignored or downplayed his warnings concerning risks of Merck & Co.'s Vioxx. The company subsequently voluntarily recalled the arthritis medication from the market after a study linked it to a higher risk of heart attack and stroke.

Overall, the FDA has issued budget requests totaling $1.9 billion, including $382 million in industry user fees. The total is 50% higher than the appropriations in fiscal year 2001 and a 4.5% increase over fiscal year 2005.

Still, the total number of drug manufacturing inspections would fall to 1,355 next Year from 1,430 this year, and the review of foreign drug plans would fall from 515 to 485.

"More than ever Americans expect FDA to protect them from risky products and potential terrorist threats, and the fiscal year 2006 budget request will equip FDA to do that," says an agency statement. "At the same time Americans increasingly rely on FDA's innovation and expertise to make significant new medical products available as soon as possible.

"This budget provides resources FDA must have for patients to enjoy the fruits of medical innovation while maintaining FDA as a gold standard for consumer protection."

FDA acting Commissioner Lester Crawford concedes that the additional monies are being sought in a climate of budgetary constraints.

"The administration is under great pressure from Congress and the public to maintain fiscal discipline and reduce the deficit," says Crawford. "However, the White House recognizes the critical nature of the FDA's work and our agency's need for adequate resources.

"Despite that vote of confidence, FDA clearly understands that the current budget situation requires innovation and creativity. FDA must leverage its resources through increased cooperation and collaboration with stakeholders, and this we pledge to do."

In addition to significant requests for food defense and counterterrorism, the FDA's budget proposal includes increases for premarket reviews of medical devices, enhanced surveillance and response, and additional resources to manage the agency's infrastructure--including restoration and consolidation of various facilities.

The FDA is seeking nearly $6 billion in additional budget authority to advance its medical device review process. The funds would supplement user fees from the medical device industry.

The agency is also pointing out that it hopes to reap over $1.5 billion in budgetary savings through its multiyear search for additional administrative efficiencies. Furthermore, the FDA is consolidating and/or postponing a number of major expenditures in the information technology arena.

"Full funding of FDA's fiscal year 2006 budget will provide the agency with the necessary resources to address the agency's public health priorities and support regulatory decisions ensuring the safety and quality of products representing almost 25% of all consumer spending by Americans," asserts the statement.
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Title Annotation:George W. Bush
Publication:Chain Drug Review
Geographic Code:1USA
Date:Feb 28, 2005
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