Conformity Magazine

In this month’s NewsBreak section, we report on an internal study released by the U.S. Food and Drug Administration (FDA) that paints a grave picture of the state of that federal agency, which serves as America’s front line against unsafe foods and drugs.

The study, entitled FDA Science and Mission at Risk, was prepared at the request of FDA Commissioner Andrew von Eschenbach by a subcommittee of the FDA’s own Science Board (which presumably operates above political agendas that might otherwise cloud such an assessment). The study’s findings will send a chill down the spine of anyone who believes that our government is taking every possible step to ensure the safety of the American public.

Among the study’s fifteen findings are the following shockers (taken right from the report’s Table of Contents):

The FDA does not have the capacity to ensure the safety of food for the nation;
The development of medical products based on “new science” cannot be adequately regulated by the FDA;
The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate;
The FDA has substantial recruitment and retention challenges;
The FDA has experience decreasing resources in the face of increasing responsibilities.

These findings would be scary enough if they were unique to the FDA. Unfortunately, as we’ve seen during the past year, the FDA isn’t the only federal agency whose greatly expanded mission has been severely compromised by lack of resources. As we’ve written previously in this column (see Conformity, October 2007), the U.S. Consumer Product Safety Commission (CPSC), which is responsible for overseeing the safety of an industry that annually sells more than $1.4 trillion worth of consumer goods, works with a budget of just $62 million and a staff of just over 400 employees!

The flap over the FDA report is just gaining traction in Congress, where the chairs of several Congressional committees have formally asked the FDA’s Science Board to comment on whether the FDA budget proposal for fiscal year 2009 is adequate to address these deficiencies. But, as with last year’s furor over the CPSC in the wake of the massive recall of unsafe toys from China, we fear that the very real challenges facing the FDA will quickly fade from view, that is, until the next major food or drug safety issue grips the attention of the American public. And that’s not a matter of “if,” but “when.”