Tom Harkin

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Homeland Security and Governmental Affairs' Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security be authorized to meet during the session of the Senate on May 24, 2012, at 10 a.m., to conduct a hearing entitled, ``Innovating with Less: Examining Efforts to Reform Information Technology Spending.''

Mr. HARKIN

Mr. HARKIN. The Senator wishes to speak on which amendment?

Mr. HARKIN. Madam President, how much time is remaining on the Grassley amendments, the amendments offered by the Senator from Iowa?

Mr. HARKIN. How much time does the Senator wish to take?

Mr. HARKIN. I would ask that 10 minutes of the time in opposition to the Grassley amendment be allocated to the Senator from Minnesota.

Mr. HARKIN. I ask 10 minutes of the time from amendment No. 2141 be yielded to the Senator from Colorado.

Mr. HARKIN. Mr. President, how much time is remaining on the Sanders amendment?

Mr. HARKIN. Mr. President, I thank the Senator from Utah for his concluding remarks regarding the amendment that I assume will be offered by the Senator from Illinois, as it is cleared to be offered. I thank Senator Hatch for his great leadership on the issue of making sure the American people can have access to healthy, life-supporting vitamins, minerals and supplements, without having it go through untold processes and reviews and approvals by the FDA, and all that kind of regulation. Senator Hatch was the leader on the DSHEA bill when we passed it in 1994. I was happy to work in tandem with him on that. It has proven, through the years, to be a great success for the American people. The American people all over this country take vitamins and other supplements, and they are living healthier because of this. I say to my friend that I heard the Senator from Illinois on the floor yesterday give an impassioned speech about a very sad case about a young woman who evidently consumed some energy drinks with a lot of caffeine in them and had heart arrest and died. It is a very sad story. But as sad as that is, you can't keep people from abusing things. People also die every year from aspirin poisoning, where they took too many aspirin. Reasonableness has to enter into this. We have worked together to make sure the labels are good on all of these things, so that people know what is in them. The FDA has the authority--as the Senator said, every Commissioner has said they have the authority to keep dangerous products off the shelf and to remove them from the shelf. They have all that authority. These cases, as I said, that Senator Durbin brought up are very sad, and you wish it were not so. I don't think it lends itself, though, to overturning what has been working now for 17, going on 18, years and working well for the American people. I join the Senator from Utah, and I hope the amendment might not come up. But if it does, it does. I am sure there will be some debate on it. I join with the Senator from Utah in urging all Members of the Senate to vote that amendment down. If it comes up, I will move to table that amendment. Hopefully, we can approach this in a much more judicious, responsible, thinking manner. I say to my friend from Utah--and I know he agrees--we are not taking the position that nothing has ever been changed. We have changed DSHEA in the past to make it work better. We did it after due deliberation, committee hearings, and going through the process to see what it means in terms of access to these products by the American people, to make sure we keep the intent of DSHEA there. Again, I am more than willing, as chairman of the committee--and the Senator used to be chairman of the committee at one time, and then ranking member--we are always willing to look at these things and have a hearing on them and get more information. Again, I thank the Senator from Utah, who has been a great leader on this issue.

Mr. HARKIN. Mr. President, how much time does this side have on the bill?

Mr. HARKIN. I reserve the remainder of my time on the bill. If the Senator from Illinois wishes to bring up his amendment, we can bring it up. Mr. President, again, I understand I have 24 minutes left.

Mr. HARKIN. I will make a short general statement about the bill. I talked about it in the past. I want every Senator to know that we are now on the FDA reauthorization bill. This is reauthorizing the prescription drug user fee, the medical device user fees, and then we are authorizing a new program, the generic drug user fee, biosimilar user fee, and so we are on the bill now. There is 30 minutes for debate on each amendment that has been listed. Senators know who they are and what the amendments are. I want to make it clear that the unanimous consent we just adopted says that all debate time will expire at 2 p.m. tomorrow. So I say to Senators, if you want to take your 30 minutes and debate your amendment, now is the time to do it. If you wait too long, 2 o'clock will come tomorrow, you won't have the time, and you will be limited to 1 minute. There will be 2 minutes on each amendment after that. Those who have amendments and wish to discuss them, you are guaranteed at least 30 minutes, but all time runs out at 2 p.m. tomorrow. If you want to talk on your amendment and make your point, now is the time to do it this afternoon. I yield the floor.

Mr. HARKIN. Mr. President, how much time remains on this amendment?

Mr. HARKIN. Mr. President, I just want to say, first of all, that I have the greatest respect, as he knows, for the Senator from Illinois. He is one of the true consumer champions in the entire Congress and has been for all of his time here. So it is kind of hard to argue against the Senator when he is such a champion of consumers. But on this issue I think we part a little company. I want to make it very clear that under DSHEA, supplement labels must already disclose their ingredients--must disclose their ingredients. Even when a product is reformulated, if the supplement contains new ingredients, then the label must reflect that change. These were all added to the bill. We added that for consumer protection. Now, again, it is not as though FDA doesn't know what is out there. Under current law, supplement manufacturers have to biannually register their products. There is a biannual registration requirement right now. So the concern is that FDA just doesn't have the resources to do anything. I have tried--and the Senator knows because he is on the Appropriations Committee--to get more funds for the FDA to do this, but we haven't been able to get the funds necessary for the FDA to even do what jobs they are supposed to do now. I repeat for emphasis sake that every FDA Commissioner--those appointed both by Democratic or Republican Presidents--have said the DSHEA gives them adequate authority to keep dangerous products off the shelves. So the authority is already there. What the FDA needs is the resources. That is money. That means appropriations. Quite frankly, I don't see that happening this year--that we are going to give them any more. We are just going to give them more of a burden, and I think it will give a false sense of security to people because FDA simply won't be able to do that. Lastly, as the Senator did say, we do have a voluntary program for ingredients and things with the dietary supplements with the National Institutes of Health that is already in place. That is coupled with the biannual reporting requirements plus the fact every dietary supplement has to have the ingredients listed on the label. So there is plenty of consumer protections out there. It is just that we can't protect a consumer who doesn't want to follow directions, who doesn't want to follow the guidelines listed on the labels themselves. I don't know how to protect people from that. Sometimes we just have to continually tell people to follow the directions. If they follow the directions, they will be fine. That is why I think this amendment is ill-timed. I said to the Senator, and I mean this, that the Senator from Utah and our committee would be more than happy to have hearings again to flesh it out a little more and to see just what might be possible. But I come down to this as the bottom line: The FDA needs more money and they need more personnel to do this job. I yield the floor.

Mr. HARKIN. Since it is my time, I yield the Senator from Maryland 5 minutes on the underlying bill.

Mr. HARKIN. Just one minor correction I would make, and that is under the DSHEA law, the FDA must approve any health claims made by any dietary supplement or vitamin. The only health claims they can make are structure function claims, but they have to be approved by the FDA. I just wanted to clear up that point. I would also say further that I honestly don't know of any vitamin or supplement that is out there in the market that is dangerous if taken as directed--if taken as directed. As I said, anybody can abuse things. But if taken as directed, I, quite frankly, don't know of any supplement out there that is dangerous. Quite frankly, if taken as directed, they help maintain people's health and keep them healthy rather than being injurious to their health. I yield the floor.

Mr. HARKIN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. HARKIN. Again, Mr. President, I have to ask, how much time remains on the bill for both sides?

Mr. HARKIN. Mr. President, I object. How much time is left on the Sanders amendment?

Mr. HARKIN. Will the Senator from Oklahoma withhold? We have some people who want to speak. Once the time has run, then we automatically move on to another amendment and could bring up the Senator's amendment at that point.

Mr. HARKIN. There is 10 minutes in opposition to the amendment.

Mr. HARKIN. Senator Mikulski was here earlier. She wants to speak on this amendment. If we just wait 5 minutes?

Mr. HARKIN. I am sorry, I was wrong. I thought the Senator wanted to speak on the Sanders amendment. She wanted to speak on the underlying bill itself?

Mr. HARKIN. The Senator just seeks 5 minutes?

Mr. HARKIN. I will yield myself a couple of minutes. I join with my colleague Senator Enzi in opposition to the Sanders amendment. We are all disturbed by a lot of what we are reading and these big settlements. I know the recent one a couple of weeks ago on Abbott Labs where part of the prosecution case was actually that this was part of their business model. Then they had to settle it. So this is all very disturbing. However, that cries out more for, perhaps, looking at the criminal charges and perhaps strengthening some of those things but not taking away exclusivity. If you do that, a lot of times you could take away exclusivity from someone who just committed a misdemeanor. A lot of these settlements were misdemeanor charges where no intent was shown. A lot of times, if you did this, you might penalize someone who maybe had done something wrong in the past, and now maybe they have new leadership, a new company, and reformed themselves, and now they have to lose their exclusivity? You would not want to do that. Third, if you do this--I think Senator Enzi pointed this out correctly--if there is no reason to settle, then people are going to go to the wall in terms of defending themselves, and DOJ doesn't have all that kind of personnel and the time to do that. I think we would then have an even worse situation of people committing fraud because then they would know they would not have any reason to settle it whatsoever. Settlement is a good tool to be used by prosecutors to get cases to justice, to make sure consumers are made whole, and to let people know they are being watched. That is what they do. I think the Sanders amendment, while maybe well-intentioned--I know it is well-intentioned. I know the Senator has all good intentions of what he wants to do. But I think it goes too far and is not the right solution to that problem. So I would oppose Senator Sanders amendment also. I yield the floor.

Mr. HARKIN. Would the Senator yield for a question?