Madam Chairman, first of all, let me express my appreciation to the leader on our side on this subcommittee, the gentlewoman from Connecticut (Ms. DeLauro). This is her first year as the minority rank on this subcommittee, and she is doing…
Madam Chairman, first of all, let me express my appreciation to the leader on our side on this subcommittee, the gentlewoman from Connecticut (Ms. DeLauro). This is her first year as the minority rank on this subcommittee, and she is doing an outstandingly good job, and we all very much appreciate the work that she is doing.
I also want to express my appreciation to my chairman. He also is doing a very good job, particularly under a very difficult set of circumstances; and those difficult set of circumstances are, particularly, the allocation that this subcommittee has been afforded. But that, of course, is universally true. All of these subcommittees have been afforded very small, ineffective allocations, ineffective to do all the things that need to be done. But, nevertheless, in spite of that, I think the chairman has done a good job.
There is one aspect of this bill, however, to which I would like to draw attention, because it is an aspect of the bill that is entirely deficient and not only deficient but, because of these deficiencies, the result is a potential for serious harm to a large number of American citizens. That is the way in which the Food and Drug Administration is treated in this legislation, and the fact that the Congress has not provided to the FDA the kinds of authority that it needs in order to protect the general public against the marketing of prescription drugs in ways that are causing serious harm to large numbers of the American people.
Now, recently we have had two experiences, that is, the Nation has had two experiences, with drugs that have been very difficult and dangerous. The first is antidepressants and the way that they have been marketed. They have been marketed largely to people who were targeted for marketing off-label. A lot of the people who they were marketed to and who used them were young folks, young people, teenagers. The effect of these antidepressants on young folks, youngsters, teenagers, people in their early 20s particularly, has been to engender in them a deep sense of depression which, in many cases, has led to suicide; and it has taken us a long time to get attention focused on that problem.
Another example is the so-called Cox-2 inhibitors, or prescriptions such as Vioxx. Vioxx has presented a major, major problem to consumers across the country. It is likely that several hundred thousand people, as a result of the use of Vioxx, have fallen into conditions where their health has been seriously injured; and it may be, and probably is, that more than 100,000 people suffered death as a result of the use of this prescription drug Vioxx.
Now, that comes about as a result of the failure of this Congress to give the FDA the kind of authority it needs to deal with the drug companies; and I later in the debate on this legislation will offer two amendments to deal with this problem.
But, right now, I want to draw the attention of the Members of this House to this issue. This is a serious issue which affects the health and safety of the American people in material and very dramatic ways. It is an issue that is causing the unnecessary death of large numbers of Americans, and it is an issue that we have not dealt with and should deal with, and if we do address it properly, it will alleviate this condition and stop placing so many of American citizens in the kind of dangerous, desperate circumstances that they have fallen into which have caused serious injury to their health and death in large numbers of people.
So what we need to do is to give the Food and Drug Administration the authority to deal with the pharmaceutical companies in the way that any regulatory agency would deal with the entity that it is regulating.
For example, in the case of Vioxx, once that drug got on the market and it became clear that people were being injured as a result of exposure to it, and the off-label marketing of that drug particularly, once that became clear, the Food and Drug Administration was not in a position to tell the drug company that they had to engage in an educational program which would ensure that people to whom the drug would be dangerous would not be using it. They could not order the pharmaceutical company to do anything with regard to the labeling on that drug. They had to negotiate with the company.
So these are some of the major issues that we are facing, one of the major deficiencies in this legislation that needs to be addressed, and I will be offering two amendments later on in the debate, and I hope that the Members of this Congress will embrace those amendments.
Mr. Chairman, I move to strike the last word.
Mr. Chairman, last night I went before the Committee on Rules to seek the ability to offer an amendment to the bill today that would have given the Food and Drug Administration, the FDA, two critically important new authorities to improve the agency's drug safety operations. It would have given FDA the authority to require drug companies to conduct post-marketing studies of FDA-approved drugs and the authority to mandate changes to the labels of FDA-approved drugs. But the Committee on Rules would not allow the amendment.
Almost every week we hear about another unsafe drug and the significant harm that those drugs are doing to millions of people. Yet Congress has done nothing. The most recent case is the cholesterol- lowering drug Crestor, which a recent study found is significantly more likely than other drugs in its class to cause muscle deterioration that can lead to kidney disease and kidney failure.
Flip through the headlines of the last few months, and we will see many more examples. Of the two most significant drug failures of the last year, they are antidepressants and Vioxx. For years, evidence was building that antidepressants seem to cause an increased rate of suicide among users,
particularly young people. The FDA, however, failed to heed this evidence and delayed taking any action for years because the agency said it did not have enough data to do anything about these reports of suicide.
The reason for this was FDA could not order the drug companies to conduct further clinical trials after a drug is approved. When the agency finally did have enough data back in 2003, it first sought to hide it but eventually told antidepressant makers that there needed to be a warning on suicide. However, it took more than 9 months before that warning was placed on any drug label because the FDA had to negotiate with the drug companies over the label's wording. Patients went 9 extra months without knowing all the risks.
Vioxx was finally removed from the market last September because it increased the risk of heart attacks and strokes. Notably, it was the drug manufacturer, Merck, that removed the drug, not the FDA. An estimated 90,000 to 140,000 Americans suffered heart attacks and strokes as a result of Vioxx. Of these, 30 to 40 percent, or as many as 60,000 people, probably died.
Dr. David Graham, a heroic doctor at the FDA, put these numbers into perspective when he testified before the Senate Finance Committee last November. He compared the number of heart attacks and strokes caused by Vioxx to plane crashes. Dr. Graham stated the Vioxx numbers are the equivalent of two to four airplane crashes every week, week in and week out, week after week, for the past 5 years. If it really were planes that were crashing, then the Congress would be doing something about it. Yet we have done nothing to empower the FDA to prevent another Vioxx.
FDA knew about the dangers of Vioxx more than 5 years ago, and in 2002 the agency decided Vioxx's label needed to have a warning about the increased risk of heart disease. Yet it took nearly 14 months before that warning was added to Vioxx's label because the FDA again had to negotiate the wording with the drug company. FDA could not simply tell Merck that its label must say Vioxx causes increased risk of heart attacks and strokes. Nor could FDA order Merck to conduct a new clinical trial about Vioxx's safety when the FDA learned of other studies indicating safety problems.
My amendment would change that. These commonsense changes are nearly universally accepted by patient safety organizations, endorsed by nearly every major medical journal, and even by a few drug companies. FDA's own director of the Office of New Drugs has said she believes it would be extremely helpful for the agency to have these powers and authorities. They are also endorsed on a bipartisan basis, including by Senators Charles Grassley and Thad Cochran, who have cosponsored a bill that would do almost exactly what I am proposing today.
These changes cannot wait to happen. They cannot wait any longer. Delay is going to cost lives, many lives, tens of thousands of lives in all probability. The amendment should have been made in order by the Committee on Rules, and I am asking the House now today to make this amendment in order. This amendment needs to be considered by the full House of Representatives, and it needs to be considered for no other reason than because by not considering it, we are placing hundreds of thousands of people across this country in dire jeopardy.
We need a Food and Drug Administration that can deal with the drug companies and with the medical manufacturing establishments that it allegedly regulates, deal with them in an effective way, so that we can have true regulation on behalf of the safety and security of the American people, which we do not have today and which this Congress has refused to bring about.
So I am taking this opportunity, Mr. Chairman, to bring this amendment to the floor of the House. I want this amendment considered, and I hope that every Member of the House will see it his or her duty to adopt this amendment today.
Amendment Offered by Mr. Hinchey
Mr. Chairman, I offer an amendment.
Mr. Chairman, I know that this issue is controversial. I know that there are Members of the House who really do not want to address it this afternoon. But we should put that aside. We should put it aside because the safety and security of the American people are at stake here.
The Food and Drug Administration was established by this Congress in order to ensure that pharmaceuticals and subsequently various forms of medical devices and other materials which are used by people who are ill, that those devices and materials can be used by people in a way that is safe and secure and sound. But the fact of the matter is that that is not happening, and we have the ocular proof in front of us every single day.
I mentioned a few moments ago the situation of antidepressants. These antidepressants came on the market without proper, careful review; and in addition to that, they began to be marketed for off-label uses. As a result, large numbers of teenagers, young people, people in their twenties, began to use them when they should not have been using them, and the usage of those antidepressants induced suicidal potential in those people, and many of them carried it out. Many, many people took their lives in direct relationship to the use of those antidepressant drugs.
When that became apparent, the Food and Drug Administration was not able to deal effectively with the drug manufacturers because they did not have the authority. They do not have the authority to tell the drug manufacturers that when a problem becomes evident after the drug is on the market that the drug company should, at the very least, change the label, put information on the label that tells people this kind of experience has been shown to happen by this group of people so that people can be warned about it and therefore not be likely to take it and so that doctors can understand that and not be likely to prescribe it.
That simple act would save the lives of tens of thousands of people. Failing to do it almost inevitably is going to cost the lives of tens of thousands of Americans, because it will not be much longer before we see another antidepressant situation or Cox-2 inhibitor situation, Vioxx situation, come on the market if we do not change the rules, if we do not give the FDA the power to deal effectively with these drug manufacturers.
The Vioxx case is a very clear, strong case in point. After a certain period of time when that drug was on the market, it became obvious that people who were taking it were suffering strokes and/or heart attacks. The FDA, when it became aware of that, was not able to do anything effectively about it. They did not even ask the drug company to take the drug off the market.
Finally, Merck came to the table and properly removed Vioxx from the market, but only after hundreds of thousands of people in this country were seriously affected, and we estimate at least 60,000 people lost their lives, and the number may be higher than that; and all of that began to get the attention of the press and people across the country began to understand it.
Now, for God's sake, what are we doing here? Are we just going to stand by idly while these circumstances continue to happen, while more and more drugs come on the market, week after week, month after month, while more and more people take them without understanding the implications and more and more people suffer, even die, as a result of that?
This Congress has the responsibility to act. We need to make that Food and Drug Administration live up to its responsibilities. And by simply saying in a technical way that, no, we cannot do it today, that does not meet the need, not by any stretch of the imagination.
This amendment needs to come to the floor, and this amendment needs to get the kind of attention that it properly deserves on behalf of the safety and security and the lives of the American people and to be adopted.
So I move the amendment, and I ask my colleagues to embrace it today. Vote for it; support it. Let us pass it this afternoon.
Point of Order
Mr. Chairman, I offer an amendment.
Mr. Chairman, I yield myself such time as I may consume.
Mr. Chairman, my amendment would prohibit the Food and Drug Administration from appointing scientists who have conflicts of interest to FDA advisory committees. The amendment does not change current law; it simply makes sure that the FDA is adhering to current law.
The FDA is charged with protecting the public health and, to assist with this mission, the FDA relies heavily on advisory committees composed of outside scientists to guide the agency policy on the safety and effectiveness of drugs and medical devices when questions arise regarding those products. While the FDA is not bound by the decisions of these panels, the agency itself calls advisory committees one of its most important resources for helping to regulate the over 150,000 marketed medical products that the FDA oversees.
Because of the critically important nature of these committees, there should be no question as to whether the committee members are looking out for the public health. But recent FDA actions have created serious doubts about whether committee members are serving only the public interests and, as a result, industry biases now taint many advisory panel decisions.
Over the past few years, the FDA has routinely waived conflict of interest prohibitions and appointed scientists with direct conflicts of interest to serve on these critical public panels. These appointments completely undermine the objectivity of this outside advice and bias the committee's recommendations, which are reached by a vote of the panel members, some of whom have financial ties to the products being reviewed by that very same panel.
There have been numerous high-profile examples of this over the past 18 months. Just this past April, for example, the FDA convened an advisory committee to examine whether or not to allow silicon breast implants back on the market. That committee contained a scientist who had just recently made a promotional video for a manufacturer of those implants.
Two months prior to that, the FDA convened an advisory panel to review the safety of Cox-2 inhibitors, drugs like Vioxx, which have caused tens of thousands of heart attacks and strokes. Ten of the 32 scientists on that panel had direct financial links to the manufacturers of those drugs. When it came time for the committee to make its recommendations, those ties made all the difference. Without the votes of the ten conflicted scientists, two of those three drugs and the Cox-2 inhibitor class would have been voted down by the panel, instead of receiving the very narrow support and approval they did as a result of those conflicted scientists' votes.
Last year, when there was a huge controversy around the link between antidepressants and suicide, especially among young people, the FDA convened an advisory panel to make recommendations on how the agency should handle those drugs. Three of the 11 scientists on that committee had been paid consultants to the manufacturers of those antidepressants.
These examples are just the tip of the iceberg. Advisory panels on OxyContin, oncology drugs, even over-the-counter athletes' foot creams, all had scientists with conflicts of interest. Almost every advisory committee meeting begins with an FDA statement waiving the conflicts of interest of some of the scientists on that panel.
If you think that scientists who rely on drug companies for their financial wherewithal are going to recommend that the FDA take action that will harm the company that is paying them, then you are living in a fantasy world.
The FDA claims that it cannot find enough qualified scientists without conflicts of interest to fill its advisory committees. This statement is laughable on its surface and an insult to the thousands of independent doctors across this country. It is also not accurate. As the medical journal, The Lancet, recently editorialized, ``It is hard to believe that in a country with 125 medical schools, not to mention the pool of international experts, the FDA cannot find experts who do not have financial ties with companies whose products are under review.'' Of course, the FDA can find scientists without conflicts of interest. They just do not want to do it, and they are not doing it.
Advisory committees are critical parts of the FDA's regulatory scheme, and they should be free of any direct conflict of interest. Without this, there is no way to assure the public that a panel's recommendations are fair and unbiased and in the interest of the public health.
After one of the most tumultuous years in the FDA's history, this amendment is needed to restore the public's confidence and integrity that has been lost in the FDA's advisory system. A wide range of public health groups support this amendment, and numerous recent editorials have called for this kind of reform. I urge all of my colleagues to support this amendment.
Mr. Chairman, I reserve the balance of my time.
Mr. Chairman, I yield 2 minutes to the gentlewoman from Connecticut (Ms. DeLauro).
Mr. Chairman, can I inquire as to how much time is remaining?
Mr. Chairman, is there anyone on the other side who wishes to speak on the amendment?
Mr. Chairman, I yield 2\1/2\ minutes to the gentleman from Arkansas (Mr. Berry).
Mr. Chairman, I yield 2 minutes to the gentleman from Michigan (Mr. Stupak).
Mr. Chairman, I yield myself such time as I may consume.
Mr. Chairman, I frankly find the arguments that have been presented against this amendment, in a word, incredible. They seem to me to be coming from the entities in our country, in our economy, that need regulation. It seems as if the words were written by them.
We have 125 medical schools in this country. We have a bevy of expert scientists who are capable of dealing with these kinds of issues. For anyone to stand on the floor of this House and say that you cannot construct a panel, an advisory panel to advise the Food and Drug Administration with regard to the safety and security of a particular drug without putting on that panel one-third of the members who are conflicted in their interests, who are being paid by the economic entities that are about to be regulated, or should be regulated, or who have done commercial advertisements for some of those entities, that you cannot construct a panel without having a third of the members with that kind of conflict of interest, is the most absurd statement I think I have ever heard uttered on the floor of this House.
We have scientific bodies throughout our government and throughout the private sector, throughout the National Institutes of Health, throughout any number of scientific organizations, who put together panels; and they are never obliged to include within those panels people who are conflicted in their interests with regard to the decisions that are going to be made by those panels. It is ridiculous, absurd to stipulate that you cannot construct a panel without having people with a conflict of interest.
I am just asking the Members of this body to tell the Food and Drug Administration that when you draw together a panel, do the same thing that other regulatory bodies do. Make sure that among the members of those panels, there is no one who is conflicted in their interests.
No one who is being monetarily compensated by the entity that is being regulated; in the case of the drug companies no one who is getting money from the drug companies, no one who is on the payroll of drug companies. That is all you have to do. It is a very simple thing. There are thousands of people to reach out to who are capable and qualified to come onto those panels and make those kinds of decisions.
To say that you cannot put together a panel without including in it one-third of the members who are conflicted in their interests is absolutely ridiculous.
And so, Mr. Chairman, I ask the Members of this body to do something that is in the best interests of the people of our Nation. Let us have a Food and Drug Administration that is actually carrying out its regulatory authorities as this Congress set them up to do.
Let us have an FDA that actually regulates the entities.
Mr. Chairman, I yield such time as she may consume to the gentlewoman from Connecticut (Ms. DeLauro).
Mr. Chairman, will the gentlewoman yield?
That is correct.
The gentlewoman from Connecticut (Ms. DeLauro) is correct. This would simply be for 1 year. It is a trial, in effect; and we ought to put it in place.
Mr. Chairman, I demand a recorded vote.