USA Patriot Act Additional Reauthorizing Amendments Act of 2006

USA PATRIOT ACT ADDITIONAL REAUTHORIZING AMENDMENTS ACT OF 2006

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Mr. GRASSLEY. Mr. President, I want to address my fellow Senators, in cooperation with my friend, Senator Baucus from Montana, on an issue that our respective staffs have been working on together for a long time. As chairman of the Finance Committee and as ranking member, we are releasing today a report. We come to the floor with our duties in mind to our constituents, to Medicaid and Medicare beneficiaries, and to all Americans, to speak of urgent matters that should concern all of us.

For more than 2 years, I have followed, with increasing concern, the performance of the Food and Drug Administration. It seems as though every week, if not every day, some new danger or risk is brought to light about an FDA-approved drug or device. As chairman and ranking member of the committee, Senator Baucus and I have a responsibility to American taxpayers to ensure that Medicare and Medicaid programs pay for medical products that have been appropriately approved in accordance with all laws and regulations. Whether a product is safe, whether a product is effective is not only a major public safety concern; it also has important financial concerns.

We understand there is a human element to the Food and Drug Administration's approval process. As a society, we recognize the anguish of families who must rely on the development of innovative, experimental, new medical products and treatments that may or may not save the life of a loved one. Our Nation is lucky to have a private marketplace that is incredibly resourceful and prolific in the field of medicine. An integral role of the Food and Drug Administration is to get these potentially lifesaving products to the market without undue delay. We also have a Government-regulated system where patients have the option to receive potentially lifesaving but unproven products by participating voluntarily in clinical trials. In the end, however, our Nation's well-founded medical system, despite its weaknesses, must always rest on sound science.

The report we are releasing today focuses on the FDA's approval process for medical devices. It is indisputable that all medical devices carry risks, but Food and Drug Administration approval is still considered the gold standard for safety and effectiveness. However, our committee staff report raises legitimate questions about the FDA's decision to approve a specific medical device. Last February, a number of concerns were raised to our committee about an implantable device called the vegus nerve stimulator or VNS, as I will refer to it. This product, VNS, is manufactured by a company called Cyberonics. Senator Baucus and I asked our committee staff to review the concerns that were given to us and report their findings. This report has three major findings which I will summarize briefly.

First, the Food and Drug Administration approved VNS for treatment-resistant depression, a new indication for this surgically implanted device. That was based upon a senior manager overruling more than 20 Food and Drug Administration scientists, medical, and safety officers, as well as managers, who reviewed the data on VNS. The high-level official approved the device despite a resolute conclusion by many at the FDA that the device did not demonstrate a reasonable assurance of safety and effectiveness.

Second, the Food and Drug Administration has not made public the level of internal dissent involved in this device approval, despite the fact that the FDA has publicized differences of scientific opinion within the agency when it has announced other controversial regulatory decisions.

Third, the Food and Drug Administration has not ensured that the public has all the accurate, science-based information on the safety and effectiveness of the VNS for treatment-resistant depression. So health care providers, relying on the FDA's information about this device, may not be able to convey complete risk information to each patient.

In the end, this senior Food and Drug Administration official not only overruled more than 20 Food and Drug Administration employees, but he stated to our committee staff that the public would not be made aware of the scientific dissent over whether the device is reasonably safe and effective. Until today, this official's detailed conclusions remain confidential and unavailable to the public. We are releasing these confidential conclusions in the appendix to the report. Some of his own conclusions raise serious questions in our minds. For example, I quote from his override memorandum:

I think it needs to be stated clearly and unambiguously that [certain VNS data] failed to reach, or even come close to reaching, statistical significance with respect to its primary endpoint. I think that one has to conclude that, based on [that] data, either the device has no effect, or, if it does have an effect, that in order to measure that effect a longer period of follow-up is required.

The events and circumstances surrounding the Food and Drug Administration's review and approval of VNS for treatment-resistant depression, which you will find detailed in this report we are releasing, raises critical questions about the Food and Drug Administration's so-called ``authoritative'' approval process. I am greatly concerned that the Food and Drug Administration standard for approval may not have been met here. If that is the case, it raises further difficult questions, including whether Medicare and Medicaid dollars should be used to pay for this device now.

Accordingly, we are forwarding the report to Secretary Leavitt, Administrator McClellan, and Acting Commissioner von Eschenbach for their consideration and comment. These are difficult matters that deserve their full attention.

Before I close, I commend the commitment and dedication of the more than 20 FDA scientists who tried to do the right thing in this case, as they probably do in every case, and not stray from evidence-based science. I applaud their effort on behalf of the American people.

I ask unanimous consent that the executive summary of the report be printed in the RECORD.

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

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