FDA Budget Offers Extra Funds for Postmarket Rx Monitoring

APRIL 01, 2005
Ken Rankin

While other federal agencies are bracing for painful funding cuts under the Bush Administration's new budget plan, drug regulators at the FDA are counting on a significant increase during the government's 2006 fiscal year.

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

Of the funds earmarked for the FDA next year, a record $6.5 million will go to the Center for Drug Evaluation's Office of Drug Safety in an effort to "increase the agency's ability to more rapidly survey, identify, and respond to potential safety concerns regarding marketed drugs."

Officials at the agency said that "despite FDA's extraordinary success in approving life-saving and life-enhancing drugs, their use by large and diverse populations may reveal problems not shown even in lengthy premarket drug trials."

The additional funding also will be used to strengthen the FDA's scientific and medical staff, and to "support greater FDA access to data on health care and drug usage"in 2006, they said.

For their part, Administration officials linked the budget increase for FDA to homeland security concerns. "More than ever, Americans expect FDA to protect them from risky products and potential terrorist threats, and the FY 2006 budget request will equip FDA to do that,"they said.

The additional money will provide the expanded resources that "FDA must have for patients to enjoy the fruits of medical innovation, while maintaining FDA as a gold standard for consumer protection,"they said.

Mr. Rankin is a freelance medical writer.