James M. Jeffords: “first of all, Senator Mikulski will be here shortly. I would like to make a few comments before I turn the floor over to…”

“first of all, Senator Mikulski will be here shortly. I would like to make a few comments before I turn the floor over to her. With respect to the devices, as I pointed out earlier and I just want to refresh everybody's recollection, the bill that we are dealing with is 152 pages long. The matters on devices are two pages. The matters on cosmetics are four. I thank the Senator from Illinois for bringing attention to some possible problems with respect to ensuring, as we all want to ensure, that there is no conflict of interest involved with any of the companies that they will be dealing with. I point out, first of all, that the FDA has total control over the third parties that will be allowed for the purposes of reviewing. They have total control over that. There are already regulations which propose to correct most of the problems, although a couple others have been raised, and we certainly are going to seriously consider amendments that will take care of those problems. Let me go through the provisions right now on the existing regulations for FDA: Can't own a device company; Can't have any ownership or financial interest in any medical device company; Can't participate in the development of medical products; Can't be a consultant; Can't prepare advice for companies; and Fees cannot be contingent on third-party recommendation.”