Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 09, 2007)

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AMENDMENT NO. 1034

Mr. DURBIN. Madam President, I have an amendment pending and scheduled for a vote this morning on the conflict of interest provision. I believe I have 5 minutes to speak to it.

The PRESIDING OFFICER. The Senator does have 5 minutes.

Mr. DURBIN. I ask the chairman and ranking member if this a convenient time to raise the issue?

Thank you very much.

Yesterday I proposed this amendment with Senator Bingaman. The Food and Drug Administration Advisory Committees make important decisions, life-and-death decisions. They decide whether the drugs and medical devices which are going to be used in America are safe and effective. In other words, if a person in America has a prescription from a doctor and takes this drug, is it going to be good for their health, or bad?

This is a critical situation. If they make the wrong decision, if the advisory committee turns a dangerous drug loose on the market, it can have terrible consequences, so these committees literally have life-and-death decisions in their hands on approving drugs, on deciding what the warning labels say, deciding what you have to say in advertising. There might be a danger in these drugs. These advisory committees are the juries of scientific experts who have to make these calls. That is one of the most important decisions of our Government.

They are not just life-and-death decisions, they are decisions involving millions and millions of dollars. Drug companies spend a fortune over a long period of time trying to bring a drug to market. They would hope this will be a drug very popular and profitable for them and their shareholders. That is a natural inclination of a business. So the advisory committee not only decides the safety and efficacy of the product, it makes a decision which has a direct impact worth millions of dollars to the drug companies involved.

Do you know what we found out? We found out over the last 10 years many people sitting on these advisory committees, those who are actually sitting on the so-called juries and deciding the fate of these drugs, have a conflict of interest. Some of them were already receiving, from the companies that make the drugs, tens of thousands of dollars in consulting fees and speaking fees. It turns out they are on the payroll, some of them, of the very companies on which they are being asked to stand in judgment. That is a conflict of interest which people cannot accept and I cannot accept.

The Food and Drug Administration argues that there are so few experts that we have to sometimes turn to those who have a conflict of interest; there is no place else to go. So occasionally we have to put a waiver in and allow someone to sit on an advisory committee panel who frankly has a financial interest in the company they are making a decision about.

That worries me. Because if you are going to have truly objective jurisdictions, that are right for the consumers of America, that approve drugs or disapprove them on the merits, not because of some inclination or prejudice which you might bring to the table, you don't need these conflicts of interest.

So basically what Senator Bingaman and I have said is: Let's strengthen the conflict-of-interest provisions on advisory committees. Let's make certain that there is confidence in the process. We know what happened with Vioxx. There were 10 people sitting on the advisory committee who had a financial conflict of interest. Had they been removed from the deliberation, the panel would not have recommended they go back on the market, endangering the health of thousands of Americans.

How can you ever justify that kind of conflict of interest? Our language tightens it. What we are trying to do is to make sure the Food and Drug Administration, with this amendment, limits the number of waivers to one per each advisory committee meeting, allows advisory committees to receive information from guest experts who have a financial conflict but prevents those experts from participating in the deliberations.

They can come in and express their point of view and then leave the room before the deliberation and the vote take place. And also strengthen the provisions to increase the outreach for new experts. The Food and Drug Administration has to do a better job of cultivating this new cadre of trustworthy experts who can serve on these advisory committees.

We have 125 medical schools in this country, 90 schools of pharmacy, 40 schools of public health. If the FDA is more aggressive in filling the slots on the advisory committees, we can remove this shadow of doubt which is over this process.

Now, some will argue: Well, the FDA has come forward with draft guidance to improve this. This is draft guidance. They are suggestions. This is law. This tells them they will have to follow the law to avoid these conflicts of interest. This is not an idea that Senator Bingaman and I bring to the table without support.

I ask unanimous consent, Madam President, to have printed in the Record with my remarks letters from the Consumers Union, the Union of Concerned Scientists, and a broader letter from 11 different organization that support this amendment, that would reduce and eliminate the conflicts of interest when it comes to approving new drugs and medical devices. What is at stake is the integrity of the Food and Drug Administration, the integrity of the process, and making certain we can say, with a straight face to American consumers, the products that are coming to the market, the life-and-death decisions that are being made that bring them to the market are being made by people who do not have a financial conflict of interest with these devices. I urge my colleagues to support the Durbin-Bingaman amendment.

I ask unanimous consent these letters be printed in the Record after my remarks.

There being no objection, the material was ordered to be printed in the RECORD, as follows:

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AMENDMENT NO. 1034

The PRESIDING OFFICER. Under the previous order, there will be 2 minutes of debate, equally divided, prior to a vote in relation to amendment No. 1034.

The Senator from Illinois is recognized.

Mr. DURBIN. Mr. President, 2 years ago, an advisory committee of the FDA sat down to judge painkiller drugs and whether they were safe to sell to America. They made the recommendation that selling Vioxx to America was safe. Ten of the members of that advisory committee had a financial conflict of interest when they made the decision. Had those 10 members with the conflict not been there, the panel would not have recommended keeping those drugs on the market.

This amendment Senator Bingaman and I offer will take the conflict of interest out of the advisory committees. We will allow one waiver for someone with a conflict of interest, and we will say that others who participate as guest experts have to leave the room before any deliberation or vote.

We will hear from the other side that the Food and Drug Administration has an idea of how they are going to change this rule at some future time. This is not an idea we are proposing, it is a law--a law to protect the integrity of the advisory committees and the drugs and medical devices which are sold across America.

I urge my colleagues to support this amendment.

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