Prescription Drug User Fee Amendments of 2007
Floor Speech
PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 08, 2007)
BREAK IN TRANSCRIPT
Mr. DURBIN. Mr. President, I have an amendment which I filed last week with Senator Bingaman on conflict-of-interest issues before the advisory committees of the Food and Drug Administration. I understand there may be an objection--I hope there is not--to setting aside the pending amendment and calling this one up for consideration. I don't want to catch anyone off guard with my request. I hope the Senator from Wyoming will note what I am about to request. If it is not consistent with his current wishes, I am asking unanimous consent that the pending amendment be set aside and that we move to amendment No. 1034 which I have filed at the desk.
The PRESIDING OFFICER. Is there objection?
Mr. ENZI. Reserving the right to object, there are several other people in that same position of wanting to call up amendments. We are trying to come up with a logical order, so I do object.
The PRESIDING OFFICER. Objection is heard.
Mr. DURBIN. I thank the Senator. I wouldn't take it personally. The issue I am raising here needs to be dispelled.
What is the Food and Drug Administration? It is a relatively small Federal agency with a huge responsibility. We spend about $1.7 billion a year on the Food and Drug Administration in a huge Federal budget. This tiny agency is responsible for the safety of about 25 percent of all that we purchase as Americans. They have responsibility when it comes to drugs, devices, biologics, food, veterinary medicines, all sorts of things, equipment. This small agency has a huge responsibility. We give them more and more things to do, and we trust the integrity of the Food and Drug Administration. We believe the Food and Drug Administration giving its approval means something. We can trust it. They have reached a decision that something we are about to buy is safe and effective. For most Americans, that is the seal of approval.
How do they reach that level of integrity? They set up advisory committees. These are the wisest men and women they can find who take a close look at each one of the things they review and inspect to determine whether they truly are safe and effective. It is kind of a jury. The jury may be 10, 20, 30 different people who sit and make a decision.
These decisions are critically important. I don't think I overstate it when I say these decisions are life-and-death decisions. They will decide that a certain pill which a pharmaceutical company says will help you with your heart condition, in fact, is safe to take and is effective, it will do what it is supposed to do. If they make a bad decision and the pill is not safe, a person's health can be jeopardized. So truly these are life-and-death decisions the advisory committees make at the Food and Drug Administration.
In addition, these are very important economic decisions. Giving the seal of approval for a new drug means for that drug company the potential of making millions, if not billions, of dollars. So the stakes are high. Each time the advisory committee makes a decision, they know lives are on the line, and they also know a thumbs-up and a decision of approval can mean the stock of this company is going to rise, their profits will rise, they will make more money for shareholders, and they will have more money for research. It is a big undertaking.
So it is not unfair for us to ask: Who are the people who sit on these advisory committees? Who are the people who are the jurors who try to impartially look at these issues and decide what is best for the American people?
Well, it turns out we have had some problems--some significant problems--in the past. One would think it would be obvious to us that we don't want to appoint people to sit on the juries, on the advisory committees, who have a conflict of interest. What about someone who is on the payroll of the pharmaceutical company that wants a drug approved; would you want that person sitting on the advisory committee? What about someone who has earned $50,000 coincidentally speaking to this company's annual retreat in some Caribbean island; would you want that person on the advisory committee? What about someone who is on the payroll receiving money from a company that can stand to make millions of dollars if the decision goes the right way? The natural human reaction is: Well, shouldn't those people sit somewhere else? They shouldn't really be in the room if we are talking about their employer, if we are talking about someone who has paid them money. They shouldn't be part of this, should they? We want people sitting in that room who don't have any conflict of interest or any vested interest in the decision. We want people who are truly objective, dispassionate, and truthful. I think most Americans would agree. That is pretty obvious.
Well, it turns out that over time the Food and Drug Administration got a little bit lax, a little bit sloppy. Back 7 or 8 years ago, USA Today published a dramatic expose about these advisory committees. They came to the conclusion that the experts sitting on these advisory committees who were supposed to be independent many times had a direct financial interest in the decision they were about to make. How often did it occur? In 92 percent of the advisory committee meetings--this goes back 7 or 8 years now, but in 92 percent of the meetings, at least one member sitting in that room deliberating had a financial conflict of interest. At more than half of the meetings, half or more of the members of the committee had a conflict of interest. What difference does it make? Does it make any difference if the person deciding the fate of a product that means profit or loss for a major corporation is on the payroll of that corporation? I think it does. It turns out it was a problem then, which the Food and Drug Administration started to address but, unfortunately, has not addressed effectively.
Last week, a study by the New England Journal of Medicine, widely recognized and respected, examined the pharmaceutical industry's financial ties to doctors. Here is what they found:
More than one-third of doctors report being reimbursed by the drug industry for the cost of attending professional meetings and continuing medical education; and almost 30 percent said they had been paid for consulting, giving lectures, or signing up patients for clinical trials.
So when it comes to doctors in general, it turns out that a third of them have a conflict of interest. So any patient walking into a doctor's office and the doctor says: You know, I think you should take XYZ drug, you would like to believe that doctor made that decision because they think that is the best drug for you or a member of your family. It is worrisome that in some instances, these doctors have a conflict of interest.
The New England Journal of Medicine also went on to say, in the words of a prominent Harvard expert, Jerry Avorn, the ``penetration of commerce into the province of science'' causes great concern. It is the same issue here when it comes to these advisory committees.
Now, the argument that comes back from the FDA and from the pharmaceutical industry is there just aren't enough smart people out there. We have to turn our employees and people we have on the payroll and people we have paid money to into these advisory committees because there aren't enough good people out there to sit on these advisory committees.
Well, I think the New York Times made a good observation when it comes to that. Here is what they said:
Unless the Food and Drug Administration makes a more aggressive effort to find unbiased experts or medical researchers to start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels.
Here is what they have found over and over again: These conflicts of interest can cause a problem.
Let's be very specific. In February of 2005, an FDA advisory committee considering the painkillers Vioxx, Bextra, and Celebrex, whether they should be sold to the public. There were 10 scientists sitting on that advisory committee who had conflicts of interest. They had some financial connection with the companies that made the products they were judging. Had the votes of those 10 scientists been excluded because of their conflicts of interest, the panel would have favored withdrawing Bextra from the market and blocking the return of Vioxx. Instead, with the 10 conflicted scientists and experts, they voted that the drugs return to the market. These drugs were very dangerous. People were having heart problems and other medical difficulties. They should never have been brought back to the market.
What impact did the presence of these people with conflicts of interest have on the deliberations? It could not have been positive. It could not have been objective. They came to this with some financial interest, at least in the companies that were affected by the decision.
Here is what my amendment does. The amendment says the Food and Drug Administration would be limited to only one waiver per advisory committee meeting.
Mr. President, I understand under a previous consent order that we are moving at 12:15 to the consideration of a judge who will be voted on in 20 minutes, Judge Kapala of Illinois. I would like to have the time start on that. I ask unanimous consent to close my remarks on my amendment, say a few words about Judge Kapala, and then the remaining 10 minutes for Senator Specter to speak.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
Mr. DURBIN. Mr. President, I will be very brief because I see Senator Specter is on the floor.
So what I am trying to do is make sure we only have one waiver per meeting, one person sitting on that advisory committee per meeting who might have a conflict of interest.
We go on to say that any person with a financial interest could provide information to an Advisory Committee but can't be participating in or voting on the final decision. I think that only makes sense.
The third thing we say is that the Food and Drug Administration has to actively promote more objective scientific experts without conflicts of interest.
I don't think this is a radical proposal. Don't we want peace of mind at the end of the day that the advisory committee has made a decision based on science and medicine and what is good for America as opposed to the bottom-line profit-and-loss statement of the pharmaceutical company?
There is a lot of discussion on this floor about the safety of drugs and the products that the FDA considers. I hope this amendment, which is critical to the integrity of the FDA, is approved by my colleagues on a bipartisan basis. I hope to offer this amendment tomorrow after we have gone through this rough procedural patch.
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