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0 'llllllll SHINGTON ~AL FOUNDATION FOR IlVIlVIEDIATE RELEASE 2009 hMASSACHUSETTS AVENUE:, N.W. • WASHEN(r E'ON. D.C. 20036 •(2p?) 588-0302 • • EWS March 4, 1993 WLF SUES FDA TO ENJOIN FEDERAL POLICY RESTRICTING HUMAN HEART VALVE TRANSPLANTS (Washington Legal Foundation v. Shalala) The Washington Legal Foundation (WLF) today filed suit in federal district court in Washington, D.C. 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 its lawsuit, 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 the suit 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. 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 last July 1. 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 lawsuit 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: "[TJhis 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 lawsuit alleges that the failure to provide that lead time deprives its clients of their rights under the MDA. Under FDA's new policy, allograft valves are available only pursuant to an IDE (an "investigational device exemption"). 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. Although the federal Health Care Finance Administration (HCFA) has decided (at FDA's request) to make an exception in the case of allograft valves to its usual policy of denying Medicare and Medicaid coverage for devices subject to an IDE, many private insurers have not yet followed suit. ~ WLF's suit also noted that FDA's actions have caused the cost of allograft valves to double in the last three years. The suit warned that if - as is very possible -- one or more of the six nonprofit tissue banks that supply allograft valves nationwide are forced out of business due to FDA's action, prices are likely to increase even more and the supply of allograft valves will shrink. 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 the lawsuit. "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. The lawsuit asks the federal court to enjoin FDA from enforcing its new policy. WLF previously filed a Citizen Petition with FDA asking it to withdraw its policy, but FDA rejected that Petition on February 8, 1993. Named as defendants in the suit are FDA Commissioner David A. Kessler and Donna Shalala, Secretary of the Department of Health & Human Services (which oversees FDA). 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. *** For further information, contact WLF Chief Counsel Richard Samp, (202) 857-0240.