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The FDA Sometimes Speaks for Itself

September 10, 2010


by Wayne Pines, President of the Alliance

The Alliance has a new ally in its efforts to increase the FDA’s budget — the FDA itself.

Until very recently, no one at the FDA was allowed to mention the unmentionable: that the agency has been chronically underfunded.  The reason is that senior officials at the Department of Health and Human Services, the Office of Management and Budget and the White House did not want the media and external audiences bringing pressure on them for the budget they proposed for the FDA.

The standard FDA response to the question, “Does the FDA need more funding?” was “We could always use more money, but we can do the job with the budget proposed.”

A few years back, with the encouragement of the Alliance and others, former Commissioner Andrew von Eschenbach broke this tradition of silence and discussed publicly the need for FDA to be funded beyond the amount requested by the Bush Administration.

This summer, we have seen a surge in resource statements from the FDA. The Commissioner, Margaret Hamburg, has done occasional interviews with the media in which she has linking the salmonella in eggs illnesses to a lack of FDA inspection resources.

The latest example was an interview that Tom Abrams, director of the Division of Drug Marketing, Advertising and Communications, gave to Reuters.  Mr. Abrams and Dr. Hamburg are both quoted as saying that the agency can barely keep up with the surge of advertising submitted for review by biopharmaceutical companies.

“Insufficient staff isn’t the agency’s only problem. It is also hampered by antiquated technology systems,” the Reuters story said.

This is the first time in several years that the advertising regulators at FDA have expressed publicly the need for more staff and more modern technology.

Such pronouncements by FDA leaders provide additional ammunition for those of us who are advocating for more funding for FDA.  When the agency itself identifies the specific areas — food safety, advertising regulation — where it believes it needs to be better funded, it must inevitably cause the senior Administration officials and the Congress to take notice.

I think the Alliance deserves some measure of credit for helping to break the FDA silence.  The Alliance put the FDA’s underfunding on the national agenda and eased the way for the FDA to speak up for itself.

Good for us! Good for the FDA!



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