Chuck Grassley

Mr. GRASSLEY

Mr. GRASSLEY. You mean we have used up all the time on our bill? I took time off of my bill.

Mr. GRASSLEY. Mr. President, today is the anniversary of the hearing on the worldwide withdrawal of Vioxx, the blockbuster drug that became a blockbuster disaster. As chairman of the Committee on Finance, I called for this hearing a year ago. The Vioxx hearing turned the spotlight on a troubled agency in denial. The type of problems exposed during the hearings have proven to be not isolated but systemic. Over the past year, my committee staff has investigated allegations coming from within and outside the Food and Drug Administration. Brave whistleblowers, such as Drs. Andrew Mosholder, David Graham, and others, have come forward to expose the too cozy relationship between the agency and the drug industry. I can tell you today that problems exist not only within the Center for Drugs but extend to the centers for devices, biologics, and even into veterinary medicine. I am concerned--and every other Member of this Senate should also be concerned--about this agency's cozy relationship with industry. To further illustrate this problem, I am sending today a letter to another drug company that appears too cozy with the Food and Drug Administration. Last year, 2 days after the Vioxx hearing, the drug company Wyeth met with former Commissioner Crawford. Why did Wyeth's CEO want to talk with the commissioner? Because Wyeth recently had to remove one of its most profitable veterinary drugs from the market. So what did Wyeth do? They launched an investigation of a Food and Drug Administration employee, Dr. Victoria Hampshire. It was Dr. Hampshire who concluded that Wyeth's drug was killing hundreds of dogs. I have in my hand what Wyeth presented to former Commissioner Crawford. Every page of this document has on it things that are referred to as confidential. It is a 29-page PowerPoint with 10 pages of backup material. It is dated November 19, 2004. Besides being marked confidential, it says: ProHeart 6 Apparent Conflict of Interest. In summary this PowerPoint alleges that Dr. Hampshire had a personal and financial conflict of interest. Dr. Hampshire approached my committee staff because she was scared and felt unfairly targeted by the Wyeth Company and also by her agency. Why? Because she was simply doing her job to check to see if drugs were as effective and safe as they were said to be. Last week, the Food and Drug Administration briefed my committee investigators on this matter. It turns out that Wyeth succeeded in having Dr. Hampshire removed from reviewing its drugs. Dr. Hampshire's hard work and dedication to science and drug safety placed a bull's eye on her back and destroyed her reputation and career--I should say temporarily destroyed her reputation. When you hear the end of this, she got commendation. Without her knowledge, the Food and Drug Administration also launched a criminal investigation against her. This sordid story is still unraveling. I can say that no action was taken against Dr. Hampshire, and after the investigation closed, the Food and Drug Administration rewarded Dr. Hampshire for her work on the Wyeth drug, which remains off the market. Unfortunately for Dr. Hampshire, Wyeth's efforts to discredit her did not end when the FDA cleared her. At least one Wyeth sales representative attempted to discredit Dr. Hampshire in the veterinary community. Fortunately for Dr. Hampshire, the salesperson's comments about Wyeth's investigation of her and her alleged conflicts of interest were made to a former colleague of Dr. Hampshire. My letter to Wyeth today seeks information and documents related to Wyeth's investigation of Dr. Hampshire and the salesperson's comments. So a year later, we are still uncovering the cozy relationship between the agency and the drug industry. In this case, a company had the guts to go to supposedly an unbiased regulating agency and tried to get somebody fired, removed, and even a criminal investigation against them, do everything to discredit them. That sort of culture and environment should not exist in any regulatory agency with the economic sectors that they are regulating. Dr. Hampshire's sad story is further proof that the Food and Drug Administration needs a permanent commissioner who can restore order and respect for independence. The Food and Drug Administration cannot serve the American people and the interests of the drug industry at the same time. A year ago, Dr. Graham created a firestorm when he said at the Vioxx hearing: I can tell you right now, there are at least five drugs on the market today that I think need to be looked at quite seriously to see whether or not they belong there. . . . Dr. Graham identified those five drugs: Accutane, Bextra, Crestor, Meridia, and Serevent, when asked by my distinguished colleague, Senator Bingaman of New Mexico. Some roundly criticized Dr. Graham's testimony as inflammatory a year ago. Today it is noteworthy that the agency has taken regulatory action or action is pending on four out of the five drugs named by Dr. Graham. Less than a week after the hearing, the Food and Drug Administration announced it was strengthening its plan to reduce the risk of birth defects associated with Accutane. Then in August the agency issued a public health advisory to help make sure females do not become pregnant while taking this medicine and to release more information about depression and suicidal thoughts associated with that drug. A month after the hearing, December of last year, the Food and Drug Administration issued a public health advisory for Bextra. The agency announced it changed Bextra's label to provide consumers with upgraded warnings about possible heart and blood clotting problems. Ultimately, the agency asked Pfizer to voluntarily remove Bextra from the market in April of this year. Less than 4 months after Dr. Graham's testimony, Crestor was subject to a public health advisory as part of the agency's effort to notify the public of potentially significant emerging safety data. Crestor's label was changed to highlight important information on the safe use of Crestor. Eight months after the hearing, the Food and Drug Administration convened an advisory committee meeting related to the safety of Serevent and other asthma drugs. The advisory committee recommended strengthening the labels for Serevent as well, but the agency has yet to act. Only one drug, Meridia, has not been the subject of any action by FDA. American consumers are the beneficiaries of these actions. I don't know if the agency would have acted without Dr. Graham's testimony before my committee a year ago. But I know from experience that sunlight is the best disinfectant. The scrutiny of the last 12 months is just the kind of medicine that the Food and Drug Administration needs. Things have not turned around overnight. Reforming this agency is a long-haul task. For those of us in Congress committed to oversight, reform, and improvement, the Vioxx investigation and hearings, as well as other investigations, prompted me to cosponsor two Food and Drug Administration reform bills this year. Senator Dodd of Connecticut and I introduced a bipartisan bill, the Fair Access to Clinical Trials Act, in February and the Food and Drug Administration Safety Act of 2005 in April of this year. These bills represent part of a sustained effort to restore public confidence in the Federal Government's food and drug safety agency. A number of you have cosponsored these bills with Senator Dodd and me. I urge everyone else who hasn't to consider them again. Enactment of these bills will be a meaningful step towards greater accountability and transparency for the Food and Drug Administration. And if enacted, they would provide the agency with some much needed authority to ensure the safety and efficacy of drugs. One big opportunity that absolutely cannot be missed right now is the appointment of a new full-time commissioner who is committed to reform. This leader must recognize the problems of a culture that has become too cozy with the industry. Then that leader must be tough enough to make necessary changes happen. The FDA has to do a top-notch job on ensuring the safety of the products it regulates. And where the FDA lacks the tools and resources to do so, Congress has to step in and help.

Mr. GRASSLEY. Mr. President, I ask unanimous consent to speak as in morning business, and the time will be off of the bill.

Mr. GRASSLEY. Mr. President, I appreciate the cooperation I have had with Senator Baucus in working out some differences on this bill, which he has enunciated very well. I look forward to, hopefully, getting done what he said before we get this bill through the Senate tomorrow.

Mr. GRASSLEY. I yield myself such time as I might consume off of our side of the Kennedy amendment.

Mr. GRASSLEY. I am going to give the Senator from Illinois an opportunity to come down out of the grandstand and play on the same playing field I do, and the Senator will have an opportunity to take care of all those people. The Senator had an opportunity 2 weeks ago on the Deficit Reduction Act. All the things we had in there for the people who do not have health care the Senator had an opportunity to vote for and didn't. Just to name a few of these: We had the Family Opportunity Act that would have helped 500,000 severely disabled children. The Senator voted against that. We had a vote against a bill in regard to the children's health insurance shortfall. The Senator voted against that. The Senator voted against an outreach and enrollment to get eligible children health care coverage for which they are entitled. If the Senator were serious about helping low-income people, the Senator would have voted for that because we took care of a lot of the children the Senator is talking about.

Mr. GRASSLEY. I raise a point of order that the amendment is not germane to the underlying bill.

Mr. GRASSLEY. Mr. President, I ask unanimous consent that the amendment be adopted.

Mr. GRASSLEY. I yield 10 minutes to Senator Kyl.

Mr. GRASSLEY. Mr. President, before we have the next rollcall on the Reed amendment, I have been asked by many Members if we could do what worked so successfully for Senator Specter on his bill by enforcing the 10-minute rule. The leader has asked me to say that is what we are going to do. So we will have regular order after the 10-minute rollcall vote, so people should stay around close to make sure they get their vote recorded. We are going to enforce the Specter rule. If you don't like it, blame Specter.

Mr. GRASSLEY. I support the LIHEAP program. Most everybody in this body supports the LIHEAP program. I have had an opportunity to vote for that even in recent days. But we have to make sure we do it in the right way. I have even tried to get oil companies to contribute to the low-income fuel fund. But here we have the Senator resurrecting the old nonworkable windfall profits tax. As Senator Domenici said in previous debate, this is one way of raising the price of gasoline and other fuels. I ask you to oppose this amendment, and I would raise the point that the amendment is not germane.

Mr. GRASSLEY. Mr. President, I have a list of amendments on which I wish to propound a unanimous consent request. I ask unanimous consent that following the disposition of the Sununu amendment, that Senator Lincoln be recognized to offer an amendment and speak for 2 minutes, after which the amendment will be withdrawn; further, that the Senate then proceed to votes in relation to the following amendments in sequence order; provided that there be 2 minutes equally divided between the votes and that no second-degree amendments be in order to the amendment prior to the vote: Schumer amendment No. 2635, Reid amendment No. 2653, Nelson amendment No. 2601, Bingaman amendment No. 2642, Durbin amendment No. 2623, and Nelson amendment No. 2625.

Mr. GRASSLEY. Mr. President, I raise the point, first of all, that we voted on a like amendment a couple of weeks ago. But I want to say why the amendment is defective, as I would have said then. It would require us to raise taxes to extend expiring tax cuts, but it would allow entitlement spending to continue to grow without any offset. This then creates a double standard between current tax law and current spending law. The amendment also is not germane, and so I raise a point of order.

Mr. GRASSLEY. Mr. President, I happen to be the original author of section 45, renewable fuels. I have extended this provision already through 2008. The amendment will undermine the reconciliation bill by going beyond our 5-year budget window, and the amendment is no longer paid for. So, regrettably, I oppose this specific amendment. But as the author of section 45, you can be assured that when it is necessary to extend it, we will. I ask you to vote against this amendment.

Mr. GRASSLEY. Mr. President, this amendment is simply not necessary. The first enrollment period began--can you believe it--just 2 days ago, and somebody says, You know, it is not long enough. It is going to last for 6 months--until May 15. There are lots of resources available. As one example, States have counselors available to assist beneficiaries under the State Health Insurance Program. That is the whole point of that program--to help beneficiaries understand the Medicare benefits in the legislation. The bottom line is that it is no picnic to sort through the fine print of health insurance. It even may rank among the most unpopular and complicated responsibilities of American adulthood--like deciphering your income tax. The Centers for Medicare and Medicaid Services developed a nationwide network of other community-based organizations that can provide beneficiaries one-on-one assistance. The prescription drug plans base their proposal to serve Medicare beneficiaries on the enrollment period specified in the law. The amendment would affect those proposals and could lead to higher costs for both beneficiaries and the government. I, for one, am tired of people on the other side seeming to have a lack of confidence in our American senior citizens who are often well informed about the choices they can make and make good decisions. This amendment is not needed, and I raise a point of order on germaneness.

Mr. GRASSLEY. Mr. President, I know this amendment is well-intended because if there is anything I hear from my constituents, particularly small business people, it is the problems with health insurance. But it is not going to work with this legislation because it is going to make the reconciliation process out of order. So I ask the Members to oppose it.

Mr. GRASSLEY. Mr. President, this amendment is also well intended. It is not germane. I am not going to raise a point of germaneness. I raise the point that it does not fit in with the reconciliation.

Mr. GRASSLEY. Mr. President, I ask unanimous consent that the amendment be adopted.

Mr. GRASSLEY. Mr. President, I ask unanimous consent that the amendment be adopted.

Mr. GRASSLEY. Mr. President, the substance of the legislation is difficult to argue with, but this is an outlay, and you can't have outlays in this particular reconciliation bill. So I raise the point of order.

Mr. GRASSLEY. Mr. President, this is one of those amendments we have dealt with four or five times. It is a tax on consumers by raising the price of gasoline. It may be used for a good purpose, but it affects the germaneness. I raise a point of order on germaneness. I ask my colleagues to vote against the amendment.

Mr. GRASSLEY. Mr. President, in conjunction with the Craig amendment, I had an amendment I was going to offer as a substitute. So I want the Grassley amendment on there as well.

Mr. GRASSLEY. Mr. President, this is another way of cutting back on the mortgage deduction, the charitable deduction, and the State and local tax deduction. When these provisions of phaseout of deductions were put in years ago, it was subterfuge for raising the marginal tax rate without raising the marginal tax rate. From Iowa, we are very transparent. If one wants to raise the marginal tax rate, raise the marginal tax rate but do not do it by subterfuge. Besides, this amendment is not germane. I raise a point of germaneness.

Mr. GRASSLEY. I ask unanimous consent we accept this amendment.

Mr. GRASSLEY. Mr. President, will the Senator yield for a minute?