Wednesday, May 21, 2008

The U.S. Supreme Court, the FDA and Reality

While the U.S. Supreme Court traces the history of how a device gets approved, the reality of the FDA is to me much different.

From the Denver Post:

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.

It's long past time to fix the FDA.