The FDA has an established protocol for approving an NRT as pharma product. It also has a history here and a constituency of companies (Big Pharma) that it has guided ("forced") down this path for years. The FDA and these constituents have a lot at stake. Yesterday's Wall Street Journal highlighted the fact that Glaxo and other manufacturers of NRT are looking to take the labeling off these products that recommend discontinuance after 12 weeks, acknowledging that many ex-smokers will use gum, lozenges and patches for the rest of their lives. The article highlighted the fact that a one to two week supply of Nicorette gum will cost a consumer $50 to $70. Compare that to what most of us are using and what that costs. This is about the money, it always has been. To say it shouldn't matter to the FDA and its constituents is profoundly naive.
