Family Smoking Prevention and Tobacco Control Act

Floor Speech

FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT -- (Senate - June 10, 2009)

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DRUG REIMPORTATION AND REFORM

Mr. VITTER. Madam President, today I rise to speak on two crucial issues which I had hoped we would not only be debating in the context of this FDA bill currently before the Senate, but actually acting on in that context. So I have to say as I speak about these two issues I am disappointed we are not taking this obvious, major opportunity of acting on a major FDA bill to again not only have me speak, but all of us act together on the crucial issues of, No. 1, the reimportation of prescription drugs; and, No. 2, meaningful generic drug reform so that we get generics to market sooner as a lower cost alternative for American consumers. I wish to touch on each of these in turn.

I was glad to support my friend, the distinguished Senator from North Dakota, and many Democratic and Republican colleagues, in introducing an amendment to the FDA tobacco bill to enact comprehensive reimportation of prescription drugs. This has long been an issue that has truly united, in a sincere bipartisan way, Democrats and Republicans. Many Democrats and many Republicans have agreed. I think at a time when, unfortunately, the partisan divide and sometimes divisive and bitter partisan rhetoric is at an all-time high, it is important to find areas where we can bridge that divide in a meaningful and sincere way.

It is important to work on real issues and real solutions together and bridge that divide. Reimportation is a great example of that.

Now, we have on record a clear majority in the Senate and well over 60 votes for reimportation. We have a clear majority in the U.S. House for reimportation, and we have an administration and a President who are for reimportation, and he is on record in that regard in his service in the U.S. Senate. In addition, we have an important issue that can save all of us and can save our health care system billions of dollars as we go into health care reform. Surely, we need to be talking and acting in ways that can cut costs in health care without endangering the public, without hurting patient care, and this is a great opportunity.

The CBO has estimated that Americans would save about $50 billion--$50 billion with a ``b''--over the next 10 years if reimportation were enacted. So we have a true bipartisan issue which has true consensus support in the Senate, in the House, and in the administration, which can save all of us and our health care system $50 billion. Let's act. Surely, this is a recipe for something we can act strongly on and produce positive results.

So what is going on? Well, I am afraid what is going on is exactly what my colleague, the Senator from Arizona, Mr. McCain, suggested on the Senate floor last week. He stood bravely on the Senate floor and read directly from a lobbyist e-mail, a lobbyist of big PhRMA, the association which represents the biggest pharmaceutical companies, and read a detailed e-mail about how they were going to block and derail this effort of mine and Senator McCain's and Senator Dorgan's and others.

I think seeing that come to pass, seeing this effort successfully blocked from the FDA bill--something that is clearly a major opportunity on which to pass reimportation, a big FDA bill--that has to grow the cynicism of the American public. Americans all across our country have to be out there thinking: OK, what is wrong with this picture? Reimportation unites Democrats and Republicans, a big majority in the Senate, a big majority in the House, the support of the President, saves the system $50 billion, obvious opportunity to pass it on an FDA bill, but, once again, it is cut off. It is blocked from consideration, from moving forward. That has to increase everybody's cynicism, and we have to work beyond that to pass this important legislation for the American people.

I am happy the majority leader has generally said he would find time on the Senate floor for consideration of a reimportation bill. We need to move. We would like a date certain, Mr. Leader, a date certain for that important consideration. After so many years of waiting, after so many years of the big PhRMA lobbyists and others blocking us from that consideration, we would like that debate and that action as soon as possible. It is certainly appropriate as we go into a major debate on health care reform.

I would underscore the same message with regard to the second crucial topic: reform with regard to generic drugs. For many months now, I have been working with several Members, most notably Senator Shaheen of New Hampshire, on bipartisan consensus generic drug reform.

Once again, I was very hopeful that this FDA bill on the floor of the Senate now would be a prime opportunity, an obvious opportunity, to pass that consensus bipartisan reform. Once again, that door was closed to us. We are not going to have that opportunity, and I express real disappointment.

But we need to act in that area. I look forward to continuing to work with Senator Shaheen, Senator Brown, and others in that important area. We have been focused on two things, in particular, that can make a huge difference.

First, we need to clear up certain loopholes, quite frankly, in the law that allowed drug companies to make labeling changes when their patent protection is about to run out, when generic was about to be open to go on the market. They were able to make slight labeling changes to extend that protection longer, in my opinion, in a somewhat artificial way. We need to reform the law and clear up those loopholes so that generic can come to market and provide Americans with a lower cost alternative.

Surely the drug companies need a period of protection so they can recoup their enormous investment in research and development. But what they don't need, and what we should not allow, in my opinion, is tweaking the labels at the eleventh hour and extending that protection in an artificial and, in my opinion, unreasonable way. That is a big area of reform I have been working on with Senator Shaheen and others.

A second area of needed reform is to elevate the Office of Generic Drugs and its importance within the FDA. We need to give it more stature. We need to have the head of that office report directly to the head of the FDA, the Administrator. We need to fund it properly so that, again, we put the proper emphasis on generic drugs. Generics are a good, safe, lower cost alternative to millions of American seniors and other Americans. They provide that today. But they can provide that lower cost alternative to an even greater extent if we take these commonsense, consensus, bipartisan measures--if we do away with these loopholes that allow last-minute labeling changes to artificially and unreasonably extend a company's patent, and if we elevate the stature of the Office of Generic Drugs within the FDA.

Again, it was an obvious opportunity to do just that in a bipartisan consensus way as we debate and act on this major FDA bill on the floor of the Senate now. I am sorry that door has been closed to us. I am sorry we have lost that opportunity. It is a shame. But we need to move on that issue, just as we need to move on reimportation now in the next few months this year in this body and in the House of Representatives.

We desperately need important health care reform. We need savings in the system to make costs of the overall health care system more reasonable, without sacrificing patient care, without telling seniors they cannot get this treatment or they cannot get that operation. These are commonsense, achievable ways to do that, by stabilizing the cost of prescription drugs. That is one of the most significant costs in our health care system with one of the most significant growth patterns. So let's act on reimportation, let's act on generics reform, let's act in a bipartisan way, let's act for the best interests of American seniors and all the American people.

With that, I yield the floor.

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