FDA Budget Offers Extra Funds for Postmarket Rx Monitoring

Pharmacy Times, Volume 0, 0

While other federal agencies arebracing for painful funding cuts underthe Bush Administration's new budgetplan, drug regulators at the FDA arecounting on a significant increase duringthe government's 2006 fiscal year.

Under the President's new budget,the FDA will receive a record $1.5 billionin federal funds plus another $382million in industry user fees—anincrease of 4.5% over this year's funding,and 50% more than the agency'sfiscal year (FY) 2001 appropriation.

Of the funds earmarked for the FDAnext year, a record $6.5 million will goto the Center for Drug Evaluation'sOffice of Drug Safety in an effort to"increase the agency's ability to morerapidly survey, identify, and respond topotential safety concerns regardingmarketed drugs."

Officials at the agency said that"despite FDA's extraordinary success inapproving life-saving and life-enhancingdrugs, their use by large anddiverse populations may reveal problemsnot shown even in lengthy premarketdrug trials."

The additional funding also will beused to strengthen the FDA's scientificand medical staff, and to "supportgreater FDA access to data on healthcare and drug usage"in 2006, they said.

For their part, Administration officialslinked the budget increase forFDA to homeland security concerns."More than ever, Americans expectFDA to protect them from risky productsand potential terrorist threats, andthe FY 2006 budget request will equipFDA to do that,"they said.

The additional money will providethe expanded resources that "FDAmust have for patients to enjoy thefruits of medical innovation, whilemaintaining FDA as a gold standard forconsumer protection,"they said.

Mr. Rankin is a freelance medical writer.