FDA, Supreme Court, and Pharmaceuticals
While reading a article about the upcoming supreme court case Wyeth v Levine at the health beat I ran across this quote:
"...The FDA is one of the most impotent federal regulatory agencies we have. Earlier this year, a former legal counsel to the FDA estimated that the agency needed to double its budget and expand its staff by 50 percent in order to effectively regulate the $1.5 trillion worth of goods that falls under its purview. Strapped for resources, in recent years the FDA has instituted a “user fees” program through which drug companies pay extra to speed up approval of their products. Every year the agency hauls in close to $400 million—or almost 20 percent of its total budget—from this program. That’s right: about one-fifth of the FDA is directly bankrolled by the prescription drug industry."
Simultaneously the drug industries conduct all of their own research on their medications and skew or manipulate (statistically) their results to hide 'adverse' effects-ie in the case of Vioxx a 3X greater risk of death from heart conditions (and yes Merck new about this and had hidden it for about 3 years while it was on the market-but don't fear they were able to buy their way out of it with $30 billion dollars in settlements). And then they submit the research they conducted to the FDA with a nice little check, which the FDA then stamps the product with their approval and out to the market!
"...The FDA is one of the most impotent federal regulatory agencies we have. Earlier this year, a former legal counsel to the FDA estimated that the agency needed to double its budget and expand its staff by 50 percent in order to effectively regulate the $1.5 trillion worth of goods that falls under its purview. Strapped for resources, in recent years the FDA has instituted a “user fees” program through which drug companies pay extra to speed up approval of their products. Every year the agency hauls in close to $400 million—or almost 20 percent of its total budget—from this program. That’s right: about one-fifth of the FDA is directly bankrolled by the prescription drug industry."
Simultaneously the drug industries conduct all of their own research on their medications and skew or manipulate (statistically) their results to hide 'adverse' effects-ie in the case of Vioxx a 3X greater risk of death from heart conditions (and yes Merck new about this and had hidden it for about 3 years while it was on the market-but don't fear they were able to buy their way out of it with $30 billion dollars in settlements). And then they submit the research they conducted to the FDA with a nice little check, which the FDA then stamps the product with their approval and out to the market!

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