James M. Jeffords: “I think I would like to talk a little bit about where we are right now in the process. We had an agreement this last…”

“I think I would like to talk a little bit about where we are right now in the process. We had an agreement this last weekend which would have allowed us to dispose of this bill without the necessity of going through the cloture process. But then fen/phen happened. All of a sudden the Nation is alarmed and concerned, and reasonably so. But to bring the pharmaceutical fen/phen issue into the device issue is disingenuous. The situation with fen/phen is that two different, approved drugs were used in combination on the basis that doctors found out that when used in combination they were more effective in achieving their purpose of reducing weight. It was determined by some astute doctors who noted that there were some problems being caused with respect to heart valves that there was a relationship between those problems and the drug combination. This was brought by the doctors to the attention of FDA, and the FDA immediately alerted the marketplace and called for a prompt in-depth evaluation. On the basis of further data the companies voluntarily removed them from the market. Now we are talking about a very, very different issue when it comes to the device issue discussed by the Senator. For instance, let's go back to fen/phen. If a drug company had to test its drug in combination with every other drug that is on the market with which it might reasonably be expected to be used in combination, it would take decades before anything would be approved.”