Spring Break
EPA And FDA Need Sweeping Reforms
Dan Cunningham
Issue date: 2/19/08 Section: Commentary
There are some days when people wonder why Americans pay federal taxes when the government is so clearly incapable of using them properly. Recently, The New York Times reported that the Food and Drug Administration broke its own rules by approving the sale of heparin from Baxter International without first inspecting the plants producing it. This glitch would not have been so bad if not for the fact that four patients died and 350 more suffered serious complications. Given that the FDA is the most important governing body in ensuring the safety of consumable goods in the U.S., it is especially disconcerting to know that its own rules can be ignored.
This incident is not alone. The Government Accountability Office has noted that the FDA has provided terrible oversight on plants in foreign countries. The FDA is supposed to inspect domestic plants every two years, while foreign producers might be inspected once every 13 years. In the face of a growing and changing economy, it is clear that the FDA is completely failing to adapt. The organization has received an increase of about 6 percent in funding a year which, in raw numbers, adds $129 million to a $2.4 billion budget. Relative to a government spending budget of $3.1 trillion, a wholesome 0.08 percent of it is spent on maintaining the safety and integrity of the products our families will consume each year.
Going just a little further with the numbers, $2.4 billion is a measly 0.02 percent of an economy $13 trillion in size. So, the question is now posed, could this department be underfunded? Is it possible that this department, whose function is to protect the people from contaminated or poisonous products, be stretched too thin? It is not as if the government does not have the money to increase the budget of one of the most important regulatory bodies in country. The government has experienced numerous events that demonstrated the FDA's clear need for more funding. From the incidents of contaminated fish, lead-painted toys from China, and now uninspected heparin plants, the government has time and time again witnessed regulatory failure and not acted.
This incident is not alone. The Government Accountability Office has noted that the FDA has provided terrible oversight on plants in foreign countries. The FDA is supposed to inspect domestic plants every two years, while foreign producers might be inspected once every 13 years. In the face of a growing and changing economy, it is clear that the FDA is completely failing to adapt. The organization has received an increase of about 6 percent in funding a year which, in raw numbers, adds $129 million to a $2.4 billion budget. Relative to a government spending budget of $3.1 trillion, a wholesome 0.08 percent of it is spent on maintaining the safety and integrity of the products our families will consume each year.
Going just a little further with the numbers, $2.4 billion is a measly 0.02 percent of an economy $13 trillion in size. So, the question is now posed, could this department be underfunded? Is it possible that this department, whose function is to protect the people from contaminated or poisonous products, be stretched too thin? It is not as if the government does not have the money to increase the budget of one of the most important regulatory bodies in country. The government has experienced numerous events that demonstrated the FDA's clear need for more funding. From the incidents of contaminated fish, lead-painted toys from China, and now uninspected heparin plants, the government has time and time again witnessed regulatory failure and not acted.
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Carl Nielsen
posted 2/20/08 @ 10:28 PM EST
Mr. Cunningham; you're right on the mark but it is not just a matter of more resources. It is also a matter of how existing resources are being used and acknowledging current organizational and IT capabilities and limitations. (Continued…)
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