Mr. President, I now move to proceed to Calendar No. 400. Mr. President, we are now on the motion to proceed to FDA user-fees legislation. I ask unanimous consent that following my remarks and those of the Republican leader, the time until…
Mr. President, I now move to proceed to Calendar No. 400.
Mr. President, we are now on the motion to proceed to FDA user-fees legislation.
I ask unanimous consent that following my remarks and those of the Republican leader, the time until 10:30 a.m. be equally divided and controlled between the two leaders or their designees, with the Republicans controlling the first half and the majority controlling the final half.
Mr. President, at 10:30 a.m. today the Senate will proceed to executive session to consider the Stein and Powell nominations, both nominees to the Board of Governors at the Federal Reserve system. At noon, there will be two votes on the confirmation of their nominations. At this stage, there likely will be no more votes after that, but we will keep everyone advised as to what is going to happen.
Mr. President, when someone we love gets sick, the only thing on your mind is how to help them get well, how to get them the care they need.
But before every miracle drug or innovative new device comes to market, there is a rigorous approval process to make sure that device or that medicine is going to be safe. To get lifesaving drugs and devices to the patients who need them as quickly and efficiently as possible, Congress must give the Food and Drug Administration the tools it needs to review and approve these products. Today the Senate will begin consideration of legislation which gives FDA the resources to ensure medical devices, drugs, and treatments are safe and effective.
I applaud the work of my colleagues Senator Harkin and Senator Enzi to bring this legislation to the floor. These two fine Senators have different political philosophies on things generally, but they work well on this committee and I am very proud of each of them. I consider them both friends. And bringing this bill to the floor in the manner they did is indicative of the work that needs to be done around here more often. So I hope to see the strong bipartisan effort these two Senators began continue as the Senate considers this important legislation.
The Food and Drug Administration Safety and Innovation Act authorizes the FDA to charge manufacturers of new medical devices user fees. These fees are used to ensure their products are reviewed quickly and thoroughly before they are approved. But this legislation does more than maintain the status quo; it also enacts crucial reforms that will prevent drug shortages
and bring the lifesaving medicines to market more quickly, it will save high-tech jobs in the medical field, make new treatments available to patients quickly, and preserve America's role as a global leader in biomedical innovation.
The legislation will expedite the processes of approving new drugs and medical devices--including many designed for children--while ensuring these products are safe for consumers. It will help spur the innovations that bring the next groundbreaking cancer or Parkinson's drug to market.
The bill will hold foreign manufacturers who sell drugs in the United States to the same high standards met by American companies. This is extremely important because of all the misleading attempts by these manufacturers to sell them on the Internet.
It will help prevent drug shortages by opening the lines of communication between manufacturers and the FDA. The Senator from Minnesota, Senator Klobuchar, and the junior Senator from Pennsylvania, Senator Casey, have been leaders in this drug shortage issue, and I applaud them. They are doing this to safeguard Americans' health. Every day hospitals across the country experience shortages of lifesaving FDA-approved drugs and treatments.
As most Senators know, my wife has been ill with cancer and she had 20 weeks of chemotherapy. Every week, we were worried that the drugs wouldn't be there on that Monday morning at noon when she got those treatments. Fortunately for us, they were. But that isn't the way it is with everyone around the country. People who need these lifesaving medications have found those medicines not available, and we have to do everything we can to stop that.
These shortages threaten public health and prevent patients from getting the care they need. The shortage of one drug used to treat a rare form of childhood leukemia--a drug that is an effective cure in 90 percent of those cases--has literally put young lives at risk by not having those drugs. And when I say a 90-percent cure rate, it is amazing. One of my high school buddies had a son who was playing Little League baseball. Running around the bases, he couldn't do it. This was a macho family with all these tough boys in the family, and they were concerned that he was not being as aggressive as he should be. He had leukemia, and this boy died. There was nothing they could do for him. He died. Now 90 percent of these cases are cured.
I have spoken on the floor before--others have--there is one form of leukemia that has been almost stopped in its tracks by the scientists discovering a bush called periwinkle, and they use the products from that little weed to cure cancer.
We need to do everything we can to make sure these lifesaving drugs are available. No mother or father should have to watch a child suffer as he waits for a lifesaving medicine. But as the number of drug shortages increases each year, more parents wait and worry; more husbands and wives and daughters and sons wait and worry.
In 2005, the FDA reported shortages of 55 medications. Last year, the number jumped to 231, including the leukemia drug I mentioned and some chemotherapy medicines. These shortages are caused by a variety of factors: problems with factories, limited manufacturing capacity, or lack of raw materials.
Another thing we have learned is the manufacturers of these products want to be able to sell everything. They don't want to waste valuable money on storing medicines. One of the big businesses that used to be in America is warehouses storing things. In Reno, NV, we were a big warehouse storage area because we had no tax on storage. But anymore, there is not as much being stored because manufacturers determined that is a waste of money. That is one of the things that happened with these pharmaceuticals.
Some, though, are caused by a lack of financial incentive--or profit motive is what it is. There is nothing wrong with that, but companies simply don't manufacture enough because they don't make enough money.
Public awareness and pressure have prompted drugmakers to voluntarily notify the FDA of any impending shortages, preventing almost 200 more shortages last year than I just talked about. But Congress can, and must, do more to improve communication with drugmakers, the FDA, and hospitals providing this crucial care.
Passing this legislation without delay will be a leap forward in that process. That is why last night I said--and I say today--I hope we don't have to file cloture on a motion to proceed to this lifesaving legislation. Let's get on this legislation. If we have to vote on cloture on this Monday, then we can't get on this until Wednesday and start legislating. How foolish.
We will have amendments. I have had a number of Republican Senators come to me and say, We want to be able to offer amendments, relevant amendments. Good. Let's do it. If someone has a problem with this bill, don't stop us from going to it; offer an amendment. If it is a worthy cause, we will vote with him or her and get rid of what is in that legislation. But don't hold up the legislation.
I would hope my Republican colleagues talk to one of the Senators who is holding us up and say, Don't do that; it is making us, the Republicans, look bad. And it does.
I hope we can get on this legislation and work to make the health care delivery system in America more effective and efficient.
Would the Chair announce the business of the day.