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0 SHINGTON GAL FOUNDATION EWS 2009 MASSACHUSETTS AVENUE, N.W. • WASHINGTON; D.C. 20036 •(l0?) 588-0302 FOR IMMEDIATE RELEASE OCTOBER 22, 1993 WLF URGES FDA TO RESCIND POLICY RESTRICTING INFORMATION FLOW ON OFF-LABEL USES OF APPROVED DRUGS AND DEVICES • The Washington Legal Foundation (WLF) today urged the Food and Drug Administration (FDA) to rescind its policies that severely restrict the free flow of truthful information regarding off-label uses of FDA-approved drugs and medical devices. In a Citizen Petition filed with FDA, WLF argued that FDA is acting in excess of its statutory authority and that its restrictions violate the First Amendment rights of both providers and recipients of such information. WLF filed the Citizen Petition on behalf of doctors and medical patients who wish to receive information about off-label uses of FDA-approved drugs and medical devices. Manufacturers of FDA-approved drugs or medical devices are required by FDA to attach to their products a label which specifies the uses for which FDA has approved the drug or device. Federal law prohibits the manufacturer from specifying on the label any uses of the product other than the precise use approved by FDA. However, doctors are free to prescribe FDA-approved products for uses other than those specified on the product label. Indeed, in many areas of medicine (particularly oncology - the study and treatment of cancer), the vast majority of treatments recognized by the medical community are "off-label" uses of FDA-approved products (i.e., uses not explicitly provided for on the product label). FDA has not attempted to interfere with off-label uses of FDA-approved drugs and medical devices. However, within the past two years, it has taken steps to interfere with the dissemination of truthful information about off-label uses. In one particularly egregious case, FDA blocked a manufacturer's attempt to distribute to doctors an authoritative medical textbook simply because the textbook contained truthful information regarding generally-accepted off-label uses of the manufacturer's cancer drugs. FDA has also threatened severe sanctions against manufacturers who become actively involved in scientific and educational programs at which off-label uses of the manufacturer's drugs or medical devices are to be discussed. FDA recently issued a policy statement entitled, "Draft Policy Statement on Industry-Supported Scientific and ~ Educational Activities, that imposes severe restrictions on manufacturer involvement in ~ ~ such programs. The result is that many such programs are being cancelled, and doctors ~ are not receiving vital information about recognized off-label uses of FDA-approved ~p ~ drugs and medical devices. ~ ~ WLF's Citizen Petition asks FDA to withdraw its Draft Policy and to refrain from ~ ~ ~

• taking any enforcement action against manufacturers who sponsor scientific or educational activities or who distribute medical textbooks that discuss off-label uses. The Petition also asks FDA to formally adopt a policy that recognizes the important role played by off-label uses of approved drugs and medical devices in the proper administration of health care in this country. "FDA's violations of basic First Amendment rights are needlessly endangering the lives of countless Americans who depend on off-label use of FDA-approved drugs for their very survival," said WLF Chief Counsel Richard Samp after filing the Citizen Petition. Samp said that WLF intends to file suit against FDA unless it agrees to reform its policies. The Citizen Petition cites children suffering from cancer as one group of citizens who are par:icuja,rly harmed by FDA's policy. The incidence of cancer among infants and children is very low in comparison to the incidence of cancer among adults. Accordingly, it is not economically feasible for a company that has developed a cancer drug to undertake the extremely time-consuming and expensive clinical trials necessary to obtain FDA approval for administering the drug to children. Nonetheless, such drugs are frequently found by pediatric oncologists to be highly effective against the cancers of children. ~ The great majority of recognized treatments of childhood cancers consist of administering FDA-approved drugs for off-label uses. But as a result of FDA's restrictions on publicizing such off-label uses, information regarding effective treatments often is delayed in reaching other physicians who are treating childhood cancers. WLF's Citizen Petition contends that FDA's restrictions on dissemination of truthful information regarding lawful uses of FDA-approved drugs and medical devices violates the First Amendment rights of both the providers and would-be recipients of such information. The Citizen Petition also contends that FDA's statutory authority to restrict "labeling" of FDA-approved products does not extend sofar far as to permit FDA to prohibit manufacturers from distributing recognized medical textbooks and/or from sponsoring scientific or educational activities. 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. *** i'.~ O For further information, contact WLF Chief Counsel Richard Samp, (202) 588-0302. cn ~ ~ i~: