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Overwhelmed at the FDA

Another report highlights the risk to public safety

Anyone paying attention to reviews of the Food and Drug Administration is aware by now that the regulatory agency is so overburdened, it poses a national health risk. In another round of warnings last week, Congress was told ''the agency is barely hanging on by its finger tips.''

The agency is responsible for ensuring the safety of the nation's drug and food supplies. As domestic and foreign production soars, the FDA has been stretched to the point of collapse. The agency is unable to keep up with its schedule of inspections of the domestic and foreign plants.

An analysis by the New York Times of a report released Tuesday by the Government Accountability Office indicates just how bad the situation is. The Times reported that at its current pace of inspections, the agency would need 1,900 years to cover all the food manufacturing plants that export to this country, 27 years for all the foreign medical device plants and 13 years for the drug manufacturing plants. Last year, a mere 30 of 3,000 drug plants and 100 of 190,000 food plants were inspected. The nation courts trouble with timelines such as these when the demand for imported foods, medical devices and pharmaceutical products is rising.

In November, a science review panel noted the FDA is unable to keep up with advances in science and technology, the critical knowledge base necessary to monitor new drugs before and after they are approved for market. Current and past reviews have said repeatedly that the FDA is severely underfunded and understaffed. Its responsibilities, meanwhile, have expanded such that the agency function effectively without substantial increases in funds and incentives to reverse the high turnover in staff.

A string of contaminated foods and recalls of flawed devices and drugs can quickly undermine confidence in the safety of products that reach every American home. What will it take for Congress and the White House to address the neglect and provide the Food and Drug Administration with the resources to ensure the necessary level of safety?

Anyone paying attention to reviews of the Food and Drug Administration is aware by now that the regulatory agency is so overburdened, it poses a national health risk. In another round of warnings last week, Congress was told ''the agency is barely hanging on by its finger tips.''

Get the full article here.


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