Tom Harkin

Mr. HARKIN

Mr. HARKIN. Madam President, how much time remains on the McCain opposition?

Mr. HARKIN. Madam President, I yield myself that time and a couple of minutes off the bill.

Mr. HARKIN. Madam President, I wish Senators to know that we will start voting here in 9 or 10 minutes, and these will be 10-minute votes. The first vote will be on the amendment offered by the Senator from Kentucky, Mr. Paul, followed by Senator McCain's amendment, Senator Sanders' amendment, Senator Durbin's amendment, and then final passage. By an earlier consent, all of those votes will be 10-minute votes. I wanted to make sure that people knew what the lay of the land was here. We are rapidly approaching the final passage of this bill. We have had great cooperation from all Senators on both sides in moving this legislation forward here on the floor. We have had good debates. They have not been drawn out endlessly, but we have had good debates and a good airing of the amendments on the bill. I thank all Senators for that, and hopefully we can move rapidly to wrap up this bill and move on. This bill is the product of 18 months of very hard work by Senator Enzi and all of the Senators on our committee on both sides of the aisle. It is a true compromise and bipartisan bill. As I mentioned earlier, it has the support of a broad spectrum of stakeholders, from the pharmaceutical companies to pharmacists to consumer organizations, across the broad spectrum who support this bill, and it is necessary that we get it done. That is why we have urged everyone to expeditiously get this done before the break period coming up for Memorial Day so the Food and Drug Administration won't have to start sending pink slips out to people this summer, and so there will not be any disruptions. It will allow them to get on with the business of making sure we get drugs and devices to patients expeditiously but safely, making sure our drugs and our devices are safe. It is a good bill, and it is the result of a lot of hard work by a lot of people, so I hope we can move these amendments rapidly and move to final passage this afternoon. I yield the floor.

Mr. HARKIN. Madam President, I yield myself as much time as I may consume off the bill.

Mr. HARKIN. Madam President, we are rapidly approaching a vote on the Paul amendment, and I know the Senator wants to have a couple of minutes to speak on that. I rise in opposition to the Paul amendment. I oppose it for several reasons. Perhaps the most important reason is that this is a drug bill. This bill deals with drugs and devices. It does not deal with food. We dealt with dietary supplements and vitamins and things such as that in the food safety bill that we passed 2 years ago and that bill, again, was a consensus bill that has been through the committee structure. We brought it to the floor and had a lot of debate on it. We made modifications at that time to the whole area of vitamins, minerals, and supplements, and that is the proper place to address it, not on a bill such as this. This bill is a bill on drugs, not on supplements and food, so that is the most important reason. I will make that same argument on the Durbin amendment. That should not be here because this is a drug bill. On substance, I would say this bill kind of turns food law on its head. It would allow supplements to be sold with claims to cure any disease, such as AIDS or cancer, without any kind of FDA review whatsoever. I take a backseat to no one in terms of my support for the vitamin, mineral, and supplement industry and their products. Senator Hatch and I were the two people who put through the DSHEA bill, the Dietary Supplementary Health and Education Act in 1994. If I might say, we have sort of been protectors of it in working to make sure it has been implemented correctly since that time. But the Paul amendment would go way too far. It is not consensus policy. In fact, it is strongly opposed by even the dietary supplement industry. I would note that the Natural Products Association, United Natural Products Alliance, and the Council on Responsible Nutrition, all three are big umbrella groups that oppose the Paul amendment. This would open this industry to snake oil salesmen. Again, those of us who want to make sure people have unfettered access to safe products and to good, nutritious vitamins, minerals, and supplements, the last thing we want to see is people in their garages mixing it up and selling it as snake oil. This is not good for America, it is not good for people who want to take vitamins and supplements and minerals for their own health. It would throw this thing open and turn the clock back 50 years or more where anybody could make any claim they want and the FDA would have no way of reviewing it whatsoever. I will move to table the amendment at the appropriate time, but I urge all Senators to oppose the Paul amendment. I yield the floor.

Mr. HARKIN. Madam President, I move to table the amendment by the Senator from Kentucky and ask for the yeas and nays.

Mr. HARKIN. I ask for the yeas and nays.

Mr. HARKIN. Mr. President, first of all, this is a drug and device bill, not a food bill. We addressed food issues in the food safety bill 2 years ago. That doesn't solve the problem Senator Durbin talked about. This bill is a very delicate balance. We have worked on this for 18 months. Stakeholders all over the country, consumers, the pharmaceutical industry, and pharmacists all support this bill. This would upset that delicate balance. I say to the Senator that every supplement has a label, the ingredients, and the potency, by law, on every single item sold as a supplement. This is a drug bill, not a food bill.

Mr. HARKIN. Madam President, I move to reconsider the vote and to lay that motion on the table. The motion to lay on the table was agreed to. Prescription Drug Information

Mr. HARKIN. I applaud the work of the Senator from New York on this legislation and share her commitment to ensuring patients receive standardized and accurate information about their prescription drugs. While verbal counseling by a pharmacist is still critical, the patient medication information is also an important resource to help patients use medications safely.

Mr. HARKIN. I agree we need to take steps to improve the information patients receive and look forward to working with the Senator on this issue.

Mr. HARKIN. The managers' amendment to 3187 revises section 506(b), removing the explicit language in current law requiring postapproval validation of surrogate endpoints. However, this is not intended to restrict the Secretary's current ability to require such validation postapproval, if appropriate. Equally important, the change likewise is not intended to suggest that any such validation should now occur prior to approval under section 506(b). Rather, in keeping with current practice, the bill's new language continues to permit the Secretary to require postapproval studies to verify the effect on the surrogate endpoint or predicted clinical outcome, i.e., verification of the predicted clinical benefit. In addition, it continues to allow the Secretary to withdraw an accelerated approval if the required studies fail to verify and describe the predicted effect.

Mr. HARKIN. Madam President, we have all put in a lot of work and benefited greatly by the constructive ideas and efforts of all the Members of this body. I sincerely thank all my colleagues, especially Senator Enzi, for their hard work on this must-pass legislation. This excellent bill is a shining example of what we can achieve when we all work together. Now we must keep our promise to patients and the biomedical industry and pass this critical bill. Today, with one vote, we can reauthorize the essential FDA's user fee agreements, systematically modernize FDA's medical product authority, and help to boost American innovation and ensure that patients have access to the therapies they need. So I urge my colleagues to join in this bipartisan spirit of cooperation and pass this important legislation, the FDA Safety and Innovation Act.

Mr. HARKIN. Madam President, I ask for the yeas and nays.

Mr. HARKIN. Madam President, today, with passage of the FDA Safety and Innovation Act and the reauthorization of the FDA user fee agreements, we have helped both the FDA and the biomedical industry ensure that they can get needed medical products to patients quickly and safely. This legislation will ensure that the FDA can swiftly approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America's global leadership in biomedical innovation. It will keep patients safer by modernizing FDA's inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices. It will reduce drug costs for consumers by speeding the approval of lower cost generic drugs and help prevent and address drug shortages. Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete in the global marketplace. By passing the FDA Safety and Innovation Act, we have taken an important step to improve American families' access to lifesaving drugs and medical devices. As I have said throughout this debate, the bipartisan process that produced this excellent bill has been quite remarkable. I have worked closely with my colleagues on both sides of the aisle, as well as industry stakeholders, patient groups, and consumer groups to solicit ideas and improvements on the critical provisions in this bill. We have a better product thanks to everyone's input. I extend a special thank-you to my colleague, Ranking Member Enzi. I have been working with Senator Enzi for over a year on this bill. It has been a wonderful and cooperative partnership and a trusting friendship. I can honestly say we would not have gotten this done without his excellent leadership and wise counsel. I thank him for that. I also thank all of the HELP Committee members, as well as members off the committee, who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups we established. Each of them has contributed significantly to this legislation, and I am sincerely grateful for all their contributions. Madam President, I will submit for the Record a list of all staff members who were part of our bipartisan working groups throughout the past year. We all know we could not have achieved this without the tireless and diligent work of our loyal staffs. I extend my deep appreciation for their hard work and extraordinary efforts. I ask unanimous consent that the list of staff members be printed in the Record.

Mr. HARKIN

Mr. HARKIN. On that note, I specifically thank the staff of Ranking Member Enzi's office. I thank Frank Macchiarola, Chuck Clapton, Keith Flanagan, Melissa Pfaff, Grace Stuntz, Katy Spangler, and Riley Swinehart. I know they have developed a close working relationship with my staff throughout the year, and I am sincerely grateful for their dedicated efforts. I thank my own staff on the HELP Committee, who have spent many a night, long days, and weekends with Senator Enzi's staff and other Members' offices working to come to consensus on the critical policy issues in this legislation. I thank our staff director, Dan Smith; his assistant, Pam Smith, who, by the way, will be very shortly taking over as our new staff director. Dan Smith is leaving our staff and going into the private sector. Pam Smith will be taking over as our new staff director. I also thank Jenelle Krishnamoorthy, who heads our health division, for all of the tireless work she has put in. I can't thank her enough for all her hard work. I also thank Elizabeth Jungman, Bill McConagha, Kathleen Laird, Kathleen Wise, Dan Goldberg, Justine Sessions, Kate Frischmann, Elizabeth Donovan, Lory Yudin, Frank Zhang, and Evan Griffis. Each of them has done a remarkable job. I thank them from the bottom of my heart for getting this legislation through. We would be remiss if we didn't also thank the Congressional Budget Office for their knowledgeable and capable team that was willing to work around the clock to estimate the budgetary effects of this legislation. Finally, we owe an enormous debt of gratitude to the staff members in the Legislative Counsel's Office. They too worked long hours, nights and weekends, to assist my staff in drafting this critical legislation and working out technical issues. This bill's passage is a victory for the millions of Americans who need medicines or medical devices--a victory that would not have been possible without the dedicated work of our Senate family. I thank all of you for your extraordinary public service.

Mr. HARKIN

Mr. HARKIN. Mr. President, while I appreciate the confidence the Republican leader has in the ability of Mr. Enzi and me to get things done, frankly, we are confronted now with two votes. Which way do we want to go? What they are proposing is that we totally end, totally eliminate all of the prevention and wellness money that we have out there in the wellness fund. What would this do? We have vaccinations for children, immunizations, smoking cessation programs, colorectal screenings, diabetes prevention, breast cancer screening, obesity prevention--all funded by this Prevention and Wellness Fund. Not one of those would be funded from that fund if that amendment passes. The choice is very clear on the two amendments we have coming up. We can either vote to close a tax loophole that allows wealthy tax dodgers not to pay their fair share of taxes--we can close that loophole and keep the interest rates at 3.4 percent--or, as the Republicans want to do, totally eliminate the Wellness and Prevention Fund and end the money that we are putting into diabetes prevention and breast cancer and colorectal screening and all the things I mentioned. I do not think the choice could be more clear to the American people about the direction we ought to go. Close the tax loophole. Keep the prevention fund in there. Keep our people healthy.

Mr. HARKIN. The President has already said if the Republican measure were to pass and sent to him, he would veto it. That is a nonstarter. Surely my friend from Tennessee does not want to cut out all of this funding that we do for hepatitis screening and colorectal screening, diabetes prevention, vaccination for our kids, all of which are funded. All of that would be ended by their amendment. I do not know what my friend is talking about in terms of student money and this and that. Their provision takes all of this money out of the Prevention and Wellness Fund. That is not what we want. We do not want to keep our kids from getting vaccinations or hepatitis screening or diabetes prevention in order to keep the interest rates low. Let's close the tax loophole that has been talked about, that both Senator Reid from Nevada and Senator Reed from Rhode Island talked about. Close that tax loophole and send it to the President. He will sign it. That way we will keep the interest rates down at 3.4 percent and not allow them to double on July 1.

Mr. HARKIN

Mr. HARKIN. Mr. President, I want to thank my friend from Rhode Island for a very eloquent speech--elegant speech too--eloquent and elegant--in portraying what is so frustrating. And that is science knows what is happening. The scientists know what is happening. We have good data points about what is happening to our climate, our atmosphere, our oceans, and yet it seems we cannot do anything about it. I say to my friend from Rhode Island, I think I was reading recently in a Scientific American magazine, which I love to read every month, that in terms of this whole global climate change, what is happening is that by the time we recognize it is happening--that is broadly, not just the scientists and others who do know what is happening--by the time it is broadly accepted, it will be too late, that we will have reached that tipping point. But the evidence is there for all to see. It is a shame that we cannot do something about it. The Senator mentioned the fish catch in Rhode Island. I think also in the recent issue of Scientific American was a story about the fisheries and oceans at large, and there were three pictures. One was a picture taken on a pier in Key West in the 1950s showing the size of the fish that were caught. Big. I think the average weight was like 30-some pounds. Then there was a picture taken in the 1970s--late 1970s, early 1980s--now it is down to maybe 15 pounds. Same pictures, same pier, same dock and everything, and now the catch is down to teeny little fish. Same place, same ocean, same waters. The article went on to point out how, if you look at the first picture, people are very happy. They are happy with this big fish. Then the second page, people are happy with what they caught. And now you have got this little teeny fish and people are still happy, because we kind of tend to accept what it is right now and be happy with what we have got without realizing what we have lost in the past. Again, I thank the Senator for his speech. We need to do more of that around here. We need to focus on this. We seem to be drifting. You are right, our grandkids are going to wonder why we did not do something.

Mr. HARKIN

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Agriculture, Nutrition, and Forestry be authorized to meet during the session of the Senate on May 24, 2012, at 2 p.m.

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Armed Services be authorized to meet during the session of the Senate on May 24, 2012, at 9:30 a.m.

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Banking, Housing, and Urban Affairs be authorized to meet during the session of the Senate on May 24, 2012, at 10 a.m., to conduct a committee hearing entitled ``The Responsible Homeowner Refinancing Act of 2012.''

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Foreign Relations be authorized to meet during the session of the Senate on May 24, 2012, at 10:30 a.m., to hold a hearing entitled, ``Ivory and Insecurity: The Global Implications of Poaching in Africa.''

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on Indian Relations be authorized to meet during the session of the Senate on May 24, 2012, in room SD 628 of the Dirksen Senate Office Building, at 2:15 p.m., to conduct a hearing entitled ``Programs and Services for Native Veterans.''

Mr. HARKIN. Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet during the session of the Senate on May 24, 2012, at 10 a.m., in SD 226 of the Dirksen Senate Office Building, to conduct an executive business meeting.