Tom Harkin

Mr. HARKIN

Mr. HARKIN. I think the Senator is making a lot of common sense. The only question I would ask is--and I don't know a lot about this. I haven't read the GAO report. But if, in fact, every employee says, I know they are going to get me on this timeliness. So it is the balance of safety and quickness, safety and expediency. In other words, we try to get a balance. We want devices and drugs approved as quickly as possible, but we don't want to jeopardize safety. Those are the two things we always try to balance here, safety being the foremost. We want things to be safe. My question is, by enshrining this into law rather than in the administration, would this somehow put more undue pressure on reviewers and others to do something quickly and jeopardize the safety aspect?

Mr. HARKIN. Madam President, an inquiry: Is the Senator bringing up-- --no, the Senator does not have an amendment pending.

Mr. HARKIN. Madam President, I join Senator Enzi in thanking Senator Burr for being not only a very valuable member of our committee but I would say the Senator's fingerprints are a lot on this bill we have before us. He has worked very hard on this bill and I think helped to improve it every step of the way over the last year. I was looking through the list of different things here. Senator Burr was one of the leaders in our working group on the supply chain, which we have in this bill to make sure those things coming from other countries have good manufacturing practices on them and we can keep track of them. The provision of clarifying the ``least burdensome'' standard on clinical data for device approval was also the result of the Senator's hard work. The Senator was also in the working group on the GAIN bill regarding antibiotic incentives for getting more incentives for new antibiotics. And there was a Burr-Coburn bill regarding enhanced reporting requirements for FDA, and that basically is also included in the bill we have in front of us. So in every respect, the Senator from North Carolina is a great member of our committee, a very valuable member of our committee. As I said, we are looking at the amendment he has now brought up, and I am sure, as Senator Enzi said, we will be talking about this in the next few hours and going into tomorrow. But I again want to pay my respect to the Senator from North Carolina and thank him for all the hard work he has done on this bill. I yield the floor.

Mr. HARKIN. Mr. President, how much time remains on the two amendments offered by the Senator from Maryland?

Mr. HARKIN. Mr. President, I ask the Senator from Colorado, how much time does the Senator seek?

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

Mr. HARKIN. Mr. President, I will speak on the time available for the amendments. Amendment No. 2125 First of all, amendment No. 2125 will help ensure that health care providers, patients, and payers better understand the benefits and risks associated with drugs, especially with respect to those drugs by underrepresented subpopulations. I believe this is an important and noncontroversial amendment. I hope we can support this amendment. Amendment No. 2141 On the other amendment, No. 2141, which is the small business report, I think it is important FDA give small businesses a helping hand. I understand each FDA center has a small business office and that each of FDA's five regional offices has a small business representative. This report the FDA would have to submit on the basis of the amendment offered by Senator Cardin would provide Congress with more information about how FDA uses its resources for small businesses to help encourage small companies. Again, I think this is another valuable addition to our bill and, hopefully, we can support that amendment also. So I thank the Senator from Maryland for his offering these two amendments and for what I consider to be improvements to the underlying bill. I thank him very much for that. Mr. President, again, I would say to the Members who may be in their offices that we still have some extra time before we will be adjourning this evening. Again, I would advise Senators that by at least 2 p.m. tomorrow, when the bell rings, we will be moving to voting, if not before then. So any Senator who has an amendment to bring up and who wishes to talk about it, I wish they would come to the floor and do that now. Mr. President, I yield the floor.

Mr. HARKIN. Mr. President, I ask unanimous consent that the time during the quorum call be divided equally.

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

Mr. HARKIN. Mr. President, I rise in opposition to the amendment offered by the Senator from Kentucky, and I oppose it for several reasons. I believe I am in the court of equity now: I come with clean hands because I am one of the authors of the Dietary Supplement and Health Education Act, along with Senator Hatch, in 1994. We worked in tandem over a period of a couple of years to get the legislation through. A lot of compromises were made at that time, not only here in the Senate but also with the House when we went to conference. I believe the right balance was struck, and I think it has proven its worth over the years. We have done some minor modifications to it over the years. As I have often said, when we write laws around here they are not chiseled in stone for all eternity. These aren't the Ten Commandments, they are laws, and sometimes they need to be modified and changed a little bit, usually tweaking. But this amendment basically turns the whole law that we had since 1994 on its head. We have a process now where the FDA regulates the supplements as foods. These are foods, not drugs. So as we hammered out this agreement, supplements can make nutrient, structure, function claims without any FDA preapproval. If they want to make a health claim, then it has to be approved by FDA, and FDA has to find that it is supported by appropriate scientific evidence. Under this amendment, substances that today are considered drugs and used to treat diseases as serious as cancer or HIV could be marketed without any rigorous FDA review that we have heard from many speakers here today is the gold standard of drug regulation throughout the world. It would turn our current system of drug regulation on its head. It would be a huge setback for health. It would foster a system rife with potential for health fraud. The big losers would be patients. Frankly, as someone who is a strong supporter of the Dietary Supplement Health and Education Act, and I would say along with Senator Hatch one of its protectors for all these years, I daresay the amendment offered by the Senator from Kentucky would destroy DSHEA. It would destroy it and I don't want to see it destroyed because I think it is doing a lot of good for a lot of people in this country. It is working well. Consumers have access to a wide range of safe products. There is no reason to upset its success, because this amendment would do that. To think that somehow you could go out and make any health claim you want? Back to the days of snake oil salesmen: ``This elixir will do everything, it will cure every ailment you have and turn the clock back 20 years on your age.'' People would buy it, and what was it? It was 80-percent alcohol and 20-percent water or something like that. They made all these crazy claims. We are going to move to that kind of system now? And the only recourse would be to take them to Federal court and then have a trial and go through all that and then, OK, then they appeal it and finally you find out, OK, the court says no, there is not enough scientific evidence to warrant it so you have to take that product off the market. We are going to do that for every one of the thousands and thousands of different products that are out there? What a mess this would be. First of all, the Federal courts would not have the wherewithal to do every one of those. Second, who has the money to take all that to court? And it would literally destroy--bring down an industry that has done well in this country. The dietary supplement industry, the vitamins and minerals industry in this country, has done a great job and I do not want to see it ruined. This would ruin it. Last, the Senator from Kentucky talked about increasing the mens rea, the mind; you know, in law school, what your mental condition, what your thought processes were--what was your intent. It would increase it. It would need to be shown to enjoin or prosecute serious violations of the Food, Drug, and Cosmetic Act. I find this amazing. This idea that we need to make it harder to enforce a public health protection statute, not easier, is deeply troubling. I see no legitimate reason to do this. The goal of this amendment is clearly to render the FDA virtually incapable of addressing industry abuses. I think this amendment would have deleterious effects on the Dietary and Supplement Education Act, and the industry, and also on the FDA's ability to regulate prescription drugs. You can say just about anything about what your health claims would be on any kind of product and the only recourse, as I said, would be to go to Federal court. Again, this is a consensus measure. We have built a very broad bipartisan support for this FDA user fee bill. It is must-pass legislation. We cannot jeopardize that consensus. For those reasons, I oppose the amendment offered by the Senator from Kentucky. Mr. President, I suggest the absence of a quorum.

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

Mr. HARKIN. Mr. President, how much time remains on the amendments offered by the Senator from Maryland, Senator Cardin?

Mr. HARKIN. Mr. President, I join Senator Enzi in thanking Senator Bennet for being a very valuable member of our committee and for all of the great work the Senator did on this bill. His fingerprints are all over this bill, and, as he pointed out, it is a great bill. There was great bipartisan support. I thank the Senator for all of his work in our working groups, especially the drug supply chain. This is a key part of this bill. The FDA will have the authority and the wherewithal to go back up the chain to where these drugs come from. The Senator was the first one to point out to me at the committee hearing that I think about 80 percent of all of the ingredients that go into our drugs in this country come from outside this country, but we had no real idea on where and how, and now we can insist on good manufacturing practices. So I would say this singular addition to this bill can be traced right back to the Senator from Colorado, and I thank him very much for his leadership on this issue and in helping us to get this bill to where we are today. I thank the Senator. I would like to yield 10 minutes off of the opposition of the Grassley amendment 2121 to the Senator from Minnesota.

Mr. HARKIN. Mr. President, as the Senator said, his amendment would amend the Controlled Substances Act to make any substance containing hydrocodone--Vicodin--a schedule II drug. As he said, this is presently a schedule III drug. The most significant difference is, for patients, schedule II drugs are not allowed to be refilled. That is the key to the amendment. I applaud the Senator. I have great concerns regarding the increased abuse of prescription drugs. According to the Centers for Disease Control and Prevention: Overdoses involving prescription painkillers are at epidemic levels-- Epidemic levels-- and now kill more Americans than heroin and cocaine combined. That is a quote from the Centers for Disease Control and Prevention. According to CDC, more than 40 people die in America every day from overdoses involving narcotic pain relievers such as hydrocodone. For this reason, I applaud Senator Manchin for his amendment and the efforts he has undertaken to reschedule this drug. It is the most frequently abused narcotic and that is a strong reason to reschedule it into section II. Again, I thank the Senator for this amendment. At the appropriate time I will ask for its adoption. Again, I thank the Senator from West Virginia. This is a great amendment. It improves the bill. It is widely accepted, and the Senator has been on the right track on this issue for a long time. I applaud him for doing this and, believe me, a lot of people in America are going to thank the Senator for getting this drug rescheduled to cut down on the terrible overuse of this drug in America. I thank the Senator very much.

Mr. HARKIN. If the Senator would withhold the unanimous consent request.

Mr. HARKIN. We have a number of amendments we are putting together, and at the appropriate time I will make sure that happens.

Mr. HARKIN. I suggest the absence of a quorum.

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

Mr. HARKIN. Mr. President, I ask unanimous consent to set aside all pending amendments in order to call up Reed amendment No. 2126, and I ask that the clerk report the amendment by number.

Mr. HARKIN. Mr. President, I further ask unanimous consent that the following amendments be agreed to en bloc: Cardin No. 2125; Cardin No. 2141; Grassley No. 2121; Grassley No. 2129; Manchin No. 2151, as modified; and Reed No. 2126.

Mr. HARKIN. Mr. President, we are finished with business for today. We do have some more amendments to be called up and voted on tomorrow. I understand we are coming in--I do not know exactly what time has been set for the morning, but after the leaders' time has been used, we will be back on this bill. Again, I remind Senators and their staffs that we have until 2 p.m. for their amendments to be brought up and to be debated. The sooner we get to those in the morning, the better off we will be. So as soon as the leader time is exhausted tomorrow morning, we will be back on our bill. So, Mr. President, I suggest the absence of a quorum and ask unanimous consent that the time in the quorum call not be taken off our bill.

Mr. HARKIN

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

Mr. HARKIN. Mr. President, we are now on the motion to proceed, as you know, to the Food and Drug Administration Safety and Innovation Act of 2012, which is basically the reauthorization of FDA for the prescription drug user fees and the medical device user fees. There are a couple of new provisions in this bill dealing with the generic drug user fees and the biosimilar drug user fees as well. So this bill is extremely important. We have been working in our committee for over a year on it, working with colleagues on both sides of the aisle. As both Senator Enzi, my ranking member, and I pointed out yesterday, this has been a true bipartisan effort. We did not divide up in terms of party--Democrat or Republican--we divided up in terms of interest areas, and we had working groups within our committee so that Senators who had a particular interest in one area or another were on that working group. We also had Senators who were not on the committee but who had interest areas in it involved in our working groups. So they and their staffs had full working knowledge of what was going on all the time and it was a true collegial effort. Those working groups completed their work earlier this year. We also called in all the stakeholders--the prescription drug manufacturers, the pharmacists, the drugstores, consumer groups, and practitioners. So we had all the stakeholders involved in this too. And now we have come up with a bill that has very broad support. I put in the Record yesterday a list of over 100 different organizations, everything from the drug manufacturers to consumer protection groups and consumer groups that are supporting this bill. It has very broad- based support. And, again, I believe that is due to the fact we proceeded on the reauthorization of this bill in the time-honored tradition of the Senate, which is for the committee to take the reauthorization prospect, to do its due diligence--and we did that for over a year, as I mentioned--and to make sure people were involved at every step of the process on both sides of the aisle. We brought in the stakeholders and continued this effort, as I said, for over a year to the point where we now have a bill that is broadly supported. As I said, everyone has a common interest in ensuring our products don't hurt patients. I have said in our hearings, and I continue to believe, safety is the paramount consideration. We cannot sacrifice patient safety on the altar of other considerations. Patient safety is still the highest standard, the highest mark at which we aim our sights. But getting the products to patients quickly is also important. I have heard heartwrenching stories of patients desperately waiting for treatments, and of inspiring accounts of small startup companies seeking to fill the needs of these patients with innovative medical products. Patient groups and industry alike have stressed the need for efficient FDA processes to get products to patients quickly. Again--and I will be pointing out later also--FDA does a very good job of getting products, both drugs and devices, to market quickly. In fact, of the 154 drugs approved in both the United States and Canada, in a study done by the New England Journal of Medicine, 132 were approved here first. So we have not been dragging our heels and FDA hasn't been dragging its heels in terms of getting the job done. Some say, well, sometimes products get approved more rapidly in Europe than they do here. That is true, but it is important to note that foreign approval standards are different. So it is kind of an apples-and-oranges kind of comparison. The FDA here approves drugs and devices based on their safety and effectiveness--safety and effectiveness. Are they safe and do they actually do what they say they are supposed to do? Other countries--basically in Europe--only consider safety and not whether the device is effective. So as long as it is safe, they approve it. So, yes, they have a shorter approval time, but they don't take into consideration effectiveness. I strongly believe the United States should keep this high standard of both safety and effectiveness. It is important to know if a device is effective because that affects a patient's decision whether to accept the device's risks and whether to forego maybe alternative treatments. FDA officials testified before our committee this year. They submitted documentation showing that 95 percent of medical device applications were reviewed within the deadlines set in the past user fee agreement. Now, despite all this good work FDA is doing, patients were sick or dying. Promising therapies can't be approved quickly enough. So the bill we have before us will continue to support the agency and its good work, but it will allow for some very big improvements. The medical device industry has agreed to double its user fees, to pay twice as much, and in return the FDA has agreed to speed review times, increase transparency, enhance communications--all of which will get devices to patients more quickly but still keep safety in mind. So anything we can do to both streamline the process, get drugs and devices to patients sooner, and make sure we keep our high standard of safety and effectiveness is not only good for business but critical for the patients who need them. I expect the FDA Safety and Innovation Act will have significant impact on FDA's ability to approve medical products in an efficient and transparent way. As I said, that benefits everyone. Investors will feel better about putting their money into medical technologies, companies will translate their research and development work into sales more quickly, support for innovation will allow the United States to maintain its leadership position in the biotech industry, and this will preserve and create jobs all over America. In this sector, as long as we preserve safety standards--which is, what is good for business is good for patients--then, again, if companies and their investors believe the climate is right to commit resources to new medical therapies, this means patients who did not previously have options will have treatments to turn to. So I say this bill is a win-win for everyone. Inspiring innovation and improving patient access to medical therapies are two of the many ways this bill modernizes our regulatory and oversight system to benefit both patients and the biomedical industry. The FDA Safety and Innovation Act is a truly bipartisan consensus bill that reflects the input and shared goals of a wide range of stakeholders. I hope we will be on the bill shortly after our noon caucuses and conferences for the two parties this afternoon. I trust that we will have only relevant amendments to the bill. I hope that has been accepted on both sides, and that we can discuss the bill and have the relevant amendments and have them disposed of sometime this week. So I am hopeful we can get this bill done before we go home for the Memorial Day recess. But we will be back on the bill this afternoon. I urge all my colleagues to give this bill their support. We will have some amendments, I am sure, that will be relevant to the bill. They will be debated and voted upon. But, nonetheless, I hope we can expeditiously move this bill and get it done. The clock is ticking. The FDA authorization runs out at the end of this summer. You might say, well, we have until then to get it done. We are out of here the month of August. We are out of here for the Fourth of July break. We have a Memorial Day break. We have appropriations bills to do. We have all kinds of things we have to do this summer. Plus, it is not waiting until the last minute. FDA needs to know very soon whether they are going to have these resources. The drug companies need to know whether FDA will have the resources to continue to do its work. So sometime midsummer FDA will probably have to start sending out pink slips to people they will not be able to keep past the end of the summer because they will not have the funds. It has been estimated that up to 2,000 people could lose their jobs at the end of this summer if we don't do our work and get this bill reauthorized. So time is of the essence. We need to get it done so we can go to conference with the House, work out whatever little disagreements we may have, and get the final bill to the President, hopefully sometime in June so the FDA then will not have to go through any processes of seeing who they are going to lay off and how they are going to close things down at the end of the summer. So, again, time is of the essence. I urge all my colleagues to support this well-thought-out bill that has taken over a year to put together. All of the stakeholders support it with broad support across America. So I hope we can get on the bill this afternoon and bring it to a close as soon as possible. Mr. President, I yield the floor, and I suggest the absence of a quorum.

Mr. HARKIN

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

Mr. HARKIN. Mr. President, I ask unanimous consent that the statement I am about to give appear as in morning business and not connected to the motion at hand.