FDA `May Fail' Without More Funds, Agency Chief Says (Update1)

By Justin Blum and Avram Goldstein

March 26 (Bloomberg) -- The U.S. Food and Drug Administration's ability to protect Americans' health is at risk, the agency's commissioner said, citing increasing responsibilities and funding that hasn't kept pace.

The FDA's regulatory role has expanded and its workforce has been overextended, Commissioner Andrew von Eschenbach said in a speech today at a conference in Washington. The FDA ``may fail in its mission to protect and promote the health of every American,'' von Eschenbach said. ``Peril exists.''

A panel of outside advisers to the agency wrote in a report last year that American lives are in danger because the FDA lacks the funding to keep up with scientific advances. The agency's budget is more than $2 billion annually. Democratic lawmakers have criticized von Eschenbach for failing to press publicly for more funding.

``Time and again we have asked Commissioner von Eschenbach to tell us what he needs but he has refused,'' said Representative Bart Stupak, chairman of the House Energy and Commerce investigations subcommittee, in an e-mail today. ``We have asked whether he is satisfied with the administration's most recent budget proposal, but he wouldn't comment.''

Stupak, a Michigan Democrat who has called for von Eschenbach to resign, said that when Congress gave the FDA a $10 million funding increase, ``he doled it out in bonuses to the agency's political appointee top brass.''

`Prognosis Excellent'

The FDA needs to be ``stronger, bigger and better'' to continue to be ``the world's gold standard as a regulatory agency,'' von Eschenbach said in his speech today.

The agency has been focused on ``how to manage and get out of this crisis,'' and ``the prognosis is excellent,'' von Eschenbach said.

President George W. Bush has proposed increasing the FDA's budget by 5.7 percent to $2.4 billion for fiscal 2009, and the agency has said von Eschenbach had sought more without saying how much he recommended.

The panel of outside advisers to the FDA said the agency's budget will need to increase to $3.7 billion by 2013, excluding rent for offices and revenue from the fees drugmakers pay for the FDA to review new product applications. The advisers, known as the Science Board, recommended increasing funding by $375 million to $460 million each year.

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Avram Goldstein in Washington at agoldstein1@bloomberg.net.

Last Updated: March 26, 2008 11:44 EDT

		Email this article Printer friendly format