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Public Statements

The Presiding Officer. The Senator from Louisiana.

Floor Speech

Location: Washington, DC


Mr. COATS. Mr. President, I rise today to talk about the Food and Drug Administration Safety and Innovation Act. I believe we are going to have a cloture vote on this bill tonight, and I am pleased that all early indications are it will pass tonight and we will move forward on this bill.

There has been considerable time spent drafting this legislation. It gained bipartisan support both in House and Senate committees, and it is moving through what I would call a regular process. We haven't seen too much of that in the last year and a half or so. This is the regular process. For those who say Congress can't get anything done, hopefully, with passage of this bill we will take a very significant step forward in terms of being able to provide and bring to patients, doctors, administrators, and others across the Nation new drugs, new treatments, and new medical devices that can ensure better health, prevent potential terminal situations, and provide better drug availability and device availability. So I think it is very important that this legislation goes forward.

I am pleased we have gotten to this point on a bipartisan basis. I think Senators Harkin and Enzi deserve commendation for their work in the Senate, and those in the House as well for bringing the bill along on a parallel track.

The whole idea of this legislation is to continue to provide the safest, most effective and most efficient drugs and devices for American citizens and people around the world. These are two very important industries in which the United States has had the leading edge as providers and we don't want to lose that. It has meant a lot for our

economy, and it has meant a lot of jobs for Americans. I think the passage of this bill will continue what has been a remarkable nearly three decades' worth of innovation that has taken place both in the biopharmaceutical industry as well as the medical device industry.

Part of this bill deals with drug shortages. I have talked to a number of doctors--my staff has been traveling the State talking to medical providers--and there is an alarming number of drug shortages in critical drugs, particularly those designed to deal with more rare instances of health problems and yet, obviously, important to those people who are suffering from those incidences of disease or health threats.

It was reported to me that last year FDA received a record number of drug shortage reports--more than 250--including critical drugs used in surgery, emergency care, and oncology. The problem continues today, but the this bill addresses that and, hopefully, will move us forward significantly in terms of dealing with this current problem.

In Fort Wayne--my hometown in Indiana--Parkview Health's pharmacy director said nearly 80 percent of hospitals consistently face shortages in drugs needed for emergencies, including cardiac and diabetic prescriptions. This bill incorporates significant reporting requirements to the FDA that I hope will help mitigate this critical problem. I think we are going to need to figure out ways to further address this, but this can be an important first step.

The whole concept has been somewhat unique in the Federal Government; that is, the makers of the products essentially pay a fee to a regulatory agency for the regulatory agency to conduct the work necessary to gain approval to sell their drugs on the market. We have had a situation which is sort of a cornucopia of new innovations in drugs and medical devices. Yet they have been delayed by the bureaucracy or the inability of the FDA to move in an efficient, effective way to run this through the process.

The biopharmaceutical industry has basically said: Look, we are willing to put up between $3.5 billion and $4 billion in new user fees--I believe it is over a 5-year period of time--which will account for nearly 60 percent of the funding designated by the Center for Drug Evaluation and Research. In exchange for putting up those fees, the FDA has agreed to new performance goals and process improvements that will reduce the time it takes drugs to reach the market.

So the key is to provide the funds necessary to hire the right people and put the right procedures in place to expedite the study and approval of safe, effective, efficient drugs that have been sent to the FDA for approval so we can get them into the market. Of course, the ultimate goal is to get them not only into the market but use them to provide health and safety benefits for the American people.

The Medical Device User Fee Act is also part of this. In Indiana, we have not only a very large biopharmaceutical company and a number of affiliated companies, we also have a vibrant and dynamic medical device industry. That industry employs over 20,000 Hoosiers directly and many more indirectly with good-paying jobs. Many of these companies are right on the leading edge of new innovation and new developments. So included in the legislation that we will be voting on is a 5-year agreement known as the Medical Device User Fee Act that improves the regulatory pathway for medical devices.

This is the medical device equivalent of the pharmaceutical user fee. Device companies have worked with the FDA, again in an agreement where each side contributes. The medical device manufacturers will contribute user fees to go to the FDA that can be used to streamline--without compromising safety in any way--the regulatory process so the approvals can be made.

Why is this important? Well, it is important not only to getting these products into the marketplace so they can be used to safely improve the health of American citizens, but this is a dynamic export industry where America has been the leading exporter of medical devices. I have heard from so many medical device manufacturers throughout Indiana that they are faced with the dilemma of having to potentially think about moving overseas simply because of the delays and the time lapse that exists for approval. They can manufacture these products overseas and get approval overseas and sell them on a worldwide basis much more quickly, but they do not want to do that. The United States is their home and they want to produce here, but they have to compete with their competitors across the waters that are subjected to fewer delays in implementing approvals.

To counter that, we simply want to use this medical device user fee in a way that will help the FDA's review process and eliminate these unnecessary delays, unpredictability, and inconsistency of past practices.

I do want to thank the FDA for paying significant attention to our device users by coming to Indiana and listening to them--a forum that I convened. There has been interaction back and forth, whether it is FDA traveling to Indiana or device manufacturers traveling here to Washington. I am pleased that this bill contains some items that are the result of all those negotiations and all those exchanges between the two.

Let me mention one last thing before closing, and that is the medical device tax, which is not part of this bill. To pay for the so-called affordable health care law, the administration included a 2.3-percent tax on medical devices, which will begin in 2013. That tax essentially was imposed on an industry that is paying its full share of taxes, contributing to the user fee, and yet it was slapped on as a way to pay for the costly health care bill. That has an enormous impact over a period of time on these device manufacturers and jeopardizes manufacturers' ability to remain based here in the United States rather than looking overseas.

There are a number of States in addition to Indiana--and my colleague from Minnesota is waiting to speak, and her State is also a major manufacturer and innovator of medical devices. California, Florida, Illinois, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, Texas, and Wisconsin will all suffer potential job losses if this medical device tax is imposed.

We are not taking it up in this bill so as not to try to derail the bill. I understand an agreement has been made that it would be set aside. I know Senator Hatch, on our side, is looking for an opportunity to bring that up in another vehicle, and I want to support that. I encourage my colleagues to take a look at the impact of that fee on our ability as a nation to be the leader in innovation and export of medical devices.

I thank Senators Harkin and Enzi for shepherding the Food and Drug Administration Safety and Innovation Act through the committee. I believe this legislation will help improve patients' access to new medical technology, and it will protect American jobs and improve the FDA so that America can remain a global leader in biomedical innovation. I encourage my colleagues in the Senate to support this important legislation.


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