El FDA quisiera que $4 mil millones reacondicionaran el dispositivo médico, supervisión de la seguridad del alimento
por
Brendon Nafziger, DOTmed News Associate Editor | February 05, 2010
Proposed budget expansion
The U.S. Food and Drug Administration sought to increase its operating budget by nearly a quarter, to $4.03 billion, to renovate its medical device, food safety and tobacco use prevention programs, the agency announced this week.
As set out in President Obama's 2011 budget proposal, the new plan calls for a 23 percent increase of the agency's current budget of $3.28 billion.
The request, which covers the 2011 federal fiscal year beginning October 1st, 2010, will help pay the salaries of more than 1,000 new workers, raising the number of employees at the agency to 13,586.
"The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day," FDA Commissioner Dr. Margaret A. Hamburg said in a statement. "This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences."
The bulk of the new money, $318 million, would go to the agency's largest and most ambitious plan, a dramatic re-working of the FDA's food safety division, with expanded powers for enforcement.
But a significant chunk of the budget request, $100.8 million, would be earmarked for its devices, drugs and vaccines division, bringing the FDA's medical product budget total to $1.4 billion. Of this, the agency hopes to devote $4 million to establishing a medical device registry.
ALMOST THERE
Over half of the new budget would come from federal funds, which would increase to about $2.5 billion, according to President Obama's 2011 budget proposal. The rest of the money would be supplied by user fees the FDA collects.
Currently, the FDA swells its budget with nearly a billion dollars in fees it levies from drug and tobacco companies.
But under proposed laws, the FDA would also get close to $289 million dollars from fees collected from food companies and firms making specialized generic biotech products.
However, it's not clear how much of this money the FDA will ever see. The Washington Post reports that the law authorizing the FDA to go after food companies for fees, passed by the House last year, has hit a roadblock in the Senate.