Prescription Drug User Fee Amendments Of 2007
I ask unanimous consent that the order for the quorum call be rescinded. As a member of the HELP Committee and someone who was an active participant in shaping this legislation, I rise to let everyone know it is very important that we pass…
I ask unanimous consent that the order for the quorum call be rescinded.
As a member of the HELP Committee and someone who was an active participant in shaping this legislation, I rise to let everyone know it is very important that we pass this bill. This legislation is perhaps one of the most important bills in more than a decade to improve drug safety. I am very distressed that for a variety of ideological reasons, this bill is being impeded. Yet drug safety should not be impeded. Drug safety is one of the most important issues we face. The recent testimony of two former FDA commissioners--one appointed by a Republican, Dr. Mark McClellan, and the other appointed by a Democrat, Dr. David Kessler--discussed the need for this legislation as one of the most important items to come before the Senate.
Congress has a unique opportunity to change the way we monitor the safety of drugs. We can't afford to miss this chance. We owe it to consumers, physicians, and patients, who rely on FDA to be the gold standard, to pass this legislation. This is about protecting the American people. There are countries all over the world that can't afford an FDA so they look to us to see what drugs are approved.
I have long been a supporter of the Food and Drug Administration. It is in my State, and I am very proud of it. I have fought hard for the employees at the FDA; for the resources to maintain the mission of the FDA. Through the years we have done a variety of things to improve FDA but nothing as important as this bill.
When we began to work on this legislation, I wanted to know what impact I could make. I was concerned about the fact that FDA seemed to have lost its way. It seemed not to have the right leadership, and it certainly didn't have the right monitoring for drug safety-- particularly post-market surveillance. So we ended up with the Vioxx situation. We ended up with drugs to treat young adolescents triggering suicidal thoughts and worse. The issue of drug safety is paramount in America. When I looked at this legislation before the HELP Committee, I wanted to find a way to strengthen the FDA but not create a whole set of regulations that were bureaucratic and technocratic but without efficacy. So where did I turn? I turned to the Institute of Medicine. The Institute of Medicine is the premier agency that often gives advice and direction to the larger community.
They published a report called ``The Future of Drug Safety.'' It had been commissioned by the FDA itself. As I read this report, I was struck by its commonsense provisions. I was also struck by the fact that we have endless reports. We have lots of commissions that Congress asks to be created, but we never act upon them. Just yesterday, the Journal of the American Medical Association ran an editorial about how the Institute of Medicine developed the right prescription for FDA, but no one is going to act on it.
Well, I acted on it. I took the prescription to help the ailing FDA. While our leadership, through Senators Kennedy and Enzi, was working a comprehensive bill, I brought to their attention these recommendations. By working in a civilized, collegial way, my amendments were adopted. It is not about my amendments. It is about the Institute of Medicine recommendations. Isn't it great when we can take the best thinking, work on a bipartisan basis, and put it into action to protect the American people. To me, that is what it is all about.
Today when I look at this bill, I am so proud of the provisions we included. It strengthens science. It increases transparency. It improves drug safety. Yet it doesn't shackle the FDA.
Let me share the recommendations of the Institute of Medicine. In terms of strengthening science, they were very clear and said that science must be strong to protect the public and to keep the best and brightest scientists at FDA. What did we do? No. 1, we created the Office of Chief Scientist at the
FDA. A single scientist will now oversee all of the offices to be sure they have strong scientific guidance from the very top of the agency. This Chief Scientist will work with a strengthened Scientific Advisory Board who will make sure the Commissioner and the Center Directors are getting the best scientific advice. Imagine, the FDA didn't have a chief scientist. We have a chief scientist at the National Space Agency. We should certainly have a chief scientist at the Nation's drug safety agency.
Then we made sure that all new drugs would be reviewed by an Advisory Committee. That means all new drugs will receive a comprehensive review. You might ask: Don't they now? No. Most got an advisory committee review, but under this legislation, there will be an advisory committee review of ALL new drugs to help assure that as a drug moves into clinical practice, it will be as safe as it can be. Remember, the FDA has a job to make sure drugs do two things: are safe and effective. These Advisory Committees will help make sure the drugs do no harm but also make sure they do good.
We also reinforced the ability of scientists at the FDA to publish their scientific papers. One might ask: Can't they now? No. If you work at the FDA, you often can't publish articles unless your boss says it is OK. Imagine that. We are talking about allowing scientists to publish in peer-reviewed scientific journals. This might sound kind of wonky, but it is important to morale. Its important for Scientists who now work at the FDA and important for recruiting new scientists that the FDA desperately needs.
The other actions we took were to improve transparency. Transparency at the FDA is critical, especially throughout the drug approval process where all scientific views, even dissenting ones, should be made public. I added provisions to make sure this will happen. Through language I had incorporated in the bill, we will make summaries of the drug approval process available to the public on the Internet. A summary will be available 48 hours after the drug is approved and the whole drug review package will be publically available within 30 days. If there are dissenting scientific views, they will also be made available as well. If you are a scientist, a researcher, even if you are a consumer, you will be able to know the history of a particular drug and review its approval process. You can learn if there were there flashing lights raised during the approval process about which you can talk to your doctor.
This is big. I know the distinguished presiding Senator was the attorney general for the great State of Colorado. I know he would also be very concerned about protecting proprietary information. This is not going to be about that. It is about safety issues, and they will be made public. We are also going to make sure patients and consumers help to make sure the FDA is communicating well with the public by creating an Advisory Committee on Risk Communication. This is modeled after two committees at the NIH and will facilitate getting FDA's message out to the public.
We also made additional changes that will directly improve drug safety. Throughout the approval process, it is important to include scientists who know how to follow drugs after they are approved. This takes me to one of my most important considerations. This legislation will strengthen the Office of Surveillance and Epidemiology to make sure it is part of the drug process from the beginning and all the way through.
This legislation will also generate additional money for drug safety. Provisions in this bill would add $29 million in PDUFA fees and up to an additional $65 million specifically for monitoring drug safety.
In sum, there are about 15 IOM drug safety recommendations we added to this bill. By working together, we have improved safety, we have improved transparency, we have improved morale, and we have improved resources. This is a good bill.
I say to my colleagues on the other side of the aisle: I don't know what you are cranky about. I don't know why you are holding up this bill. I will tell you what I am cranky about. I am real cranky when a drug goes out into clinical practice, and all of a sudden kids have problems. Kids have problems because they are trying to be like other kids. They are taking medication and it triggers something biomedical in their brain and gives them very dark thoughts. We don't want them to do dark things to each other. I am cranky when we have a doctor working in a rural part of my State, who doesn't have the time to read every medical journal but is relying on the fact that the drug he is prescribing to a patient for a heart condition has been approved by the FDA. He relies on the FDA to make sure that drug is as safe and as reliable as that doctor is in his own clinical practice.
I get cranky, real cranky, when we cannot improve drug safety. If we want to talk about that, we have to get back to mission and to purpose. It is the mission of the FDA to stand sentry over our food and drug supply to ensure safety and efficacy. It is incumbent upon us to give them the right policy framework and the right resources. I think we ought to get into action and pass this bill. Let's work together to make sure that when we talk about defending America, we defend Americans by passing this bill.
I yield the floor and suggest the absence of a quorum.