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ASHINGTON LEGAL FOUNDATION • • 2009 MASSACHUSETTS AVENUE, N.W. • WASHINGTON, D.C. 20036 •(202) 588-0302 FOR IlM[NMDIATE RELEASE September 2, 1994 WLF URGES APPEALS COURT TO ENJOIN FEDERAL POLICY RESTRICTING HUMAN HEART VALVE TRANSPLANTS (Washington Legal Foundation v. Shalala) The Washington Legal Foundation (WLF) today urged the United States Court of Appeals for the District of Columbia Circuit to block a Food and Drug Administration policy that is placing significant roadblocks in the path of heart patients who seek human-tissue heart valve transplant surgery. In a brief filed with the appeals court, WLF argued that all clinical evidence supports the conclusion that such surgery is both safe and effective, and is far superior to alternative treatments. WLF filed this lawsuit, Washington Legal Foundation v. Shalala, in March 1993 on behalf of two women in need of heart valve surgery and one of the nation's top cardiac surgeons: Dr. Robert B. Karp, Chief of the Cardiac Surgery Section at the University of Chicago Medical Center. WLF is also a plaintiff. A federal district judge in Washington, D. C. ruled in July 1993 that FDA did not exceed its powers when it imposed onerous new regulations on human-tissue heart valve surgery. The appeals court is now hearing WLF's appeal from that decision. The appeals court has scheduled oral arguments in the case for November 16, 1994 before a three judge panel consisting of Judges Wald, Edwards, and Randolph. Even as WLF was filing its brief, FDA was giving signals that it may withdraw its controversial policy rather than defending it in court. Government officials have indicated that FDA has tentatively decided to rescind its decision to classify human-tissue heart valves as Class III medical devices. In the absence of that classification (the classification that leads to the most stringent level of government regulation), suppliers of human-tissue heart valves would no longer be required to obtain a PMA (pre-market approval) before making the valves available for general distribution. Accordingly, the rescission of the Class III classification would be a tremendous victory for WLF and its clients. FDA began asserting regulatory authority in this area three years ago. In June 1991, FDA ruled for the first time that human heart valves (which have been used surgically for 30 years) are subject to FDA's premarket approval (PMA) requirements. That ruling became effective on July 1, 1992. Obtaining a PMA for human heart valves could take as long as five years. In the meantime, use of human-tissue heart valves (also known as allograft valves) in valve-replacement surgery will be so heavily restricted as to make them unavailable to many heart patients. WLF's appeals court brief argues that FDA's action not only violates the law but also makes no medical sense in light of the universal acceptance of allograft valve transplants within the medical community as safe and effective. Allograft valves are viewed as essential for the survival of many infants born with heart defects. Dr. Richard A. Hopkins, Director of

• Pediatric Cardiac Surgery at Georgetown University Medical Center and a supporter of WLF's on-going efforts to reform FDA policy, has been blunt in his assessment of FDA's policy: he said in support of an earlier WLF petition to FDA that FDA's "bureaucratic regulatory posturing" could cause "the needless death of children. " Hopkins added: "[T]his adversarial posture by the FDA is counterproductive to the patient's benefit, totally unnecessary, and an unprovoked antagonistic approach, which will result in children's death, higher costs of medical care, and enormously increased bureaucratic administrative requirements for the delivery of optimal health care. " FDA is acting pursuant to its authority under the Medical Device Amendments of 1976 (the "MDA"), which granted FDA regulatory authority over medical "devices." WLF's lawsuit contends that allograft heart valves do not fall within the MDA's definition of "devices. " Indeed, for many years following the enactment of the MDA, FDA agreed with that position. However, in 1991, FDA not only reversed its position but also announced that its new position would become effective immediately; the effective date was later extended until July 1, 1992. By requiring immediate compliance, FDA deprived the non-profit tissue banks that supply allograft valves with the several-year lead time normally provided under the MDA within which to obtain a PMA for the medical device in question. WLF's brief to the appeals court alleges that the failure to provide that lead time deprives its clients of their rights under the MDA. ~ H Under FDA's new policy, allograft valves are available only pursuant to an IDE (an investigational device exemptton ). Limiting allograft-valve transplant surgery to IDE clinical use has the potential for drastically curtailing their availability, since such surgery is now only available through restricted and carefully monitored clinical studies. Moreover, such surgery is no longer financially feasible for some heart patients, because most health insurance will not cover medical procedures that have been deemed investigational. WLF's brief also noted that FDA's actions have caused the cost of allograft valves to double in the last three years. Other types of heart valves (mechanical valves and those made from pig tissue) continue to be available. However, WLF's suit notes, cardiac surgeons are virtually unanimous in finding that allograft valves are superior to other types of valves in many situations -- particularly cases involving young children with congenital heart defects. "FDA's new policy is a virtual death warrant for many infants in need of heart valve . surgery," said WLF Chief Counsel Richard Samp after filing WLF's brief. "It is difficult to fathom what FDA thinks it is doing, in light of the total absence of any evidence that allograft valves pose any health or safety risk," Samp said. WLF is a public interest law and policy center with more than 100,000 members and supporters nationwide. It devotes a substantial portion of its resources to defending the rights of individuals and businesses to go about their affairs without undue interference from ~ government regulators. ~ ~ *** ~ Ca For further information, contact WLF Chief Counsel Richard Samp, (202) 588-0302. ~ ~ GL~