Without resources, FDA can't protect consumers

By The Denver PostArticle Last Updated: 05/20/2008 08:25:17 PM MDT

The Food and Drug Administration has finally acknowledged that it needs more resources to protect consumers from tainted food and drugs.

Unfortunately, it took the deaths of 81 people, a browbeating by members of Congress and a report detailing the FDA's woeful inability to expand overseas inspections before top agency officials would ask for more money.

It was a puzzling situation and one that has to make you wonder whether the Bush administration was putting the bottom line ahead of the health and safety of the American public.

Last week, FDA Commissioner Andrew C. von Eschenbach finally wrote Congress to say the agency needs an extra $275 million to make sure that food, drugs and medical devices from overseas are safe. The Senate appropriations committee quickly approved the request.

Given the high-profile instances of tainted products in recent years, it has become abundantly clear that the FDA does not have the resources to adequately inspect rising numbers of imports.

Last year, there was a string of pet deaths from melamine-contaminated wheat gluten imported from China. This year, the deaths of 81 people have been linked to tainted batches of the blood-thinning drug Heparin, also imported from China.

A recent Government Accountability Office report said the FDA would need $70 million to do a proper job of inspecting foreign facilities. However, the agency now gets only $11 million for that task.

Over the last few months, there has been a growing bipartisan consensus over the need for the FDA to do a better job of ensuring the safety of imported food, medicines and medical products.

Last year, the agency was able to inspect just 30 of the more than 3,200 foreign drug companies. This year, it planned to do 50 such inspections.

The Bush administration had proposed increasing the FDA budget by $50.7 million. And while that would raise the agency budget to $1.77 billion, the increase was not going to be enough to even cover routine salary increases at the agency.

The $275 million approved by the Senate committee would be used this way: an additional $125 million for food safety, $100 million for medical product and drug safety, $40 million to modernize FDA's science and $10 million for upgraded laboratories and facilities.

Public advocates for consumer safety are praising the potential for additional resources.

Protecting consumers from contaminated products is a basic and important government function. It's clear that the FDA has not had the resources to keep up with the globalization of the industries that the agency is charged with regulating.

The proposed infusion will set the FDA on the right course, and we hope Congress approves the additional funding.

http://www.denverpost.com/opinion/ci_9325000