Bart Stupak: “this does not require any new duties, none whatsoever. If the chairman would point that out to me, maybe we could have a…”

“this does not require any new duties, none whatsoever. If the chairman would point that out to me, maybe we could have a discussion about it; but there are no new duties being required here. It does not require the drug companies to do anything different than they were required to do in 1997. They do not have to report the results of the studies. They just have to report it. In addition, it does not mandate posting trials for anything else, because we have limited it more to the serious and life-threatening, exactly what the law said in 1997. We did not expand the scope of it. The FDA simply has to enforce what they are supposed to enforce by law. The FDA has already published several guidelines to drug companies about which drug trials have to be listed, when they have to be listed, and what has to be listed. If they can get them listed, it can be approved. The amendment simply instructs the Secretary of HHS, not FDA but HHS, to ensure compliance. It makes sure one hand of the HHS talks to the other. When we drafted this amendment, it should be made germane because it concerns the use of funds for carrying out the Federal Food, Drug and Cosmetic Act and funds for that purpose provided in the bill. As to whether there are those duties, I referred to the Secretary here. I did not refer to anyone else, the same as the 1997 law.…”