The FDA and the Drug Approval Process
Monday, September 13, 2010 at 11:28PM The FDA and the Drug Approval Process
If you were the Food and Drug Administration (FDA), you might look around and ask why one crisis is never enough? Just when the sting from tainted lettuce, poisonous peanuts and adulterated Chinese milk was starting to subside, you are slapped with a good ol’ helping of tainted eggs in the heartland. And that is before we even start talking about the ‘Drug’ portion of the Agency’s mandate. At the same moment that the FDA is fighting off criticism regarding Avandia and Meridia, new companies with drugs to address the obesity epidemic are waiting on the stoop, hoping to step through what might turn out to be a revolving door into and out of market approval. And this month when the FDA finally thought it was acting ahead of the curve by removing the drug midodrine from the market over possible safety concerns, the outcry from patients was so vocal that the Agency immediately reversed itself.
The FDA is appointed the very difficult task of deciding what is and what is not safe for us regular folk to put into our bodies. The agency’s goal is to maintain the proper balance between protecting the public and allowing drugs on the market that will benefit patients. The very nature of this mammoth undertaking means that the FDA’s failures will always shine more brightly than its successes. On the bright side, at least the FDA doesn’t have to worry about mining or off-shore drilling. In this issue, we take another look at the most powerful wild card in biotechnology investing – the FDA’s drug approval process.
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