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| M E M O R A N D U M TO: Reporters and Editors FR: Jill Kozeny, for Sen. Grassley, 202/224-1308 Wendy Carey, for Sen. Baucus, 202/224-6769 RE: FDA, Cyberonics DA: Friday, July 15, 2005 Senate Finance Committee Chairman Chuck Grassley and Ranking Member Max Baucus issued the following comment this afternoon. "The Finance Committee will continue its inquiry into the Food and Drug Administration's consideration of the pre-market approval supplement for the vagus nerve stimulator to be used for depression that is treatment-resistant. Both the effectiveness and the safety of medical devices must be ensured prior to their approval by the Food and Drug Administration." |
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| Statement of Peter Lurie, MD, MPH, Deputy Director, Public Citizen’s Health Research Group The decision by the U.S. Food and Drug Administration (FDA) to approve the Vagus Nerve Stimulator (VNS) for treatment-resistant depression is one of its most questionable regulatory decisions made by the agency in recent memory. As a consequence of the FDA’s data-free decisionmaking, hundreds of thousands of patients with severe depression are likely to undergo surgery to implant a device that has not been proved to work. |
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| Dr. Richard P. Malone, who served on the expert panel that scrutinized the VNS data, said he was not convinced the device met the agency's standard for a reasonable assurance of safety or efficacy. "I would hope approval meant for a treatment in psychiatry that there were clear data (showing) it is or isn't effective," Malone told United Press International. "If (receiving) an official approval it would have been shown to be effective in well designed studies -- this wasn't." |
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| Floor Statement of U.S. Senator Chuck Grassley of Iowa Nomination of Dr. Lester Crawford to Commissioner of the Food and Drug Administration Monday, July 18, 2005 I rise to address the nomination of Dr. Lester Crawford to be Commissioner of the Food and Drug Administration. I have considered Dr. Crawford’s experience and performance on the job for well over a year now. In fact, Dr. Crawford has been the man in charge at FDA since I began taking a hard look at the FDA. It has been a long year for the FDA, and I have taken a long look at Dr. Crawford’s efforts to address FDA’s problems. I know Dr. Crawford is intimately familiar with how the FDA operates. He has twice served as acting Commissioner, most recently since March 2004, and his lengthy service at the FDA is commendable. Dr. Crawford and I have met on a couple occasions. He seems to have the best of intentions. He told me personally that he understands there are problems at the FDA that need to be fixed. I believed at one point that he was capable of fixing those problems. However, as the saying goes, “the proof is in the pudding.” Today, I am here to say that I cannot vote for Dr. Crawford to be the next Commissioner of the FDA. During the last 18 months, this country’s confidence in the FDA has been shaken. It has been shaken not because of one isolated incident or one isolated whistleblower. It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower. My oversight of the FDA leads me to the conclusion that there are cultural and systemic problems at the FDA. Unfortunately, Dr. Crawford has long been part of that same culture and system. The evidence is overwhelming that the FDA must change to better protect the American people. Dr. Crawford does not appear willing to be the man to change the FDA. During Dr. Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent. First, with Dr. Mosholder finding a link between anti-depressants, children and suicide. And second with Dr. Graham’s allegations regarding the FDA, Vioxx and post-marketing safety generally. Dr. Graham’s testimony before the Finance Committee suggests that the problems are systemic. Oversight of the FDA exposed the cozy relationship that exists between the FDA and the drug industry. It revealed that the FDA negotiated for almost two years with Merck about how to change the Vioxx label so people would know about the risk of heart attacks. But the problems are not isolated to the Center for Drug Evaluation and Research. My staff continues to interview FDA staff across the agency, employees who are doing important work on drugs, devices, and biologics. It is becoming more and more obvious to me that FDA is plagued by structural, personnel, cultural, and scientific problems. Those problems should be equally obvious to Dr. Crawford. But under the leadership of Dr. Crawford, the FDA appears to be in a state of denial. Over the past 18 months, Dr. Crawford has not stepped up to the plate. I have seen no recognition of the depth and breadth of the problems at the FDA. I have only seen a few short-term band-aids. The systemic problems at the FDA demand visionary leadership. Dr. Crawford has not shown me that he is the leader to fix the FDA. |
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| Dear Dr. Crawford: The Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs, among other matters. Accordingly, the Committee is responsible to the more than 80 million Americans who receive health care coverage under those programs, including payment for medical devices. Today, Guidant Corporation (Guidant) issued a press release entitled, “Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Certain Pacemakers.” Guidant’s action today, which the company says the Food and Drug Administration (FDA) may classify as a recall, comes on the heels of recalls for several other Guidant devices, specifically Implantable Cardiac Defibrillators. As Chairman of the Committee, I request that the FDA provide the Committee with copies of the past five annual postapproval reports—required under 21 C.F.R. 814.84—for all pacemakers and defibrillators associated with Guidant’s device warnings, issued on May 25, June 17, June 24 and July 18, 2005. In addition, it is my understanding that the FDA does not presently make all device manufacturers’ annual postapproval reports publicly available, despite the fact that the reports contain important performance data. Among other detailed information, pacemaker and defibrillator manufacturers must report to the FDA the number of patient deaths, analyses of failure mechanisms, and other safety and effectiveness issues. Given the importance of such information to health care providers and the scientific community, state why the FDA should not proactively post such information in the FDA’s electronic reading room. In addition, describe in detail the FDA’s disclosure policy with respect to post approval-related documents for devices, including but not limited to pacemakers and defibrillators. |