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0 SHINGTON EGAL FOUNDATION EWS 2009 MMASSACHUSETTS AVENUE, N.W. • WASHINGTON, D.C. 20036 •(20?) 588-0302 aE am FDA RESPONDS TO WLF PETITION REGARDING OFF-LABEL DRUG USE BY INDEFINITELY POSTPONING ISSUANCE OF REGULATORY GUIDELINES • • A top Food and Drug Administration (FDA) official indicated last week that FDA has indefinitely postponed issuance of regulatory guidelines regarding off-label drug use in order to provide itself with an opportunity to address objections to the guidelines raised by the Washington Legal Foundation (WLF). The FDA action is a significant victory for WLF, which has contended that FDA,s actions -- by severely restricting the free flow of truthful information regarding off-label uses of FDA-approved drugs and medical devices -- violate the constitutional rights of both providers and recipients of such information. WLF's objections came in the form of a Citizen Petition filed 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, in

• draft form, a policy statement entitled, "Draft Policy Statement on Industry-Supported Scientific and Educational Activities," that imposes severe restrictions on manufacturer involvement in such continuing medical education ("CME") programs. The result is that many CME programs are being cancelled, and doctors are not receiving vital information about recognized off-label uses of FDA-approved drugs and medical devices. WLF's Citizen Petition asked FDA to withdraw its Draft Policy and to refrain from taking any enforcement action against manufacturers who °;~&.tsor CME programs or who distribute medical textbooks that discuss off-label us?s:- The peu*ion asked FDA to formally adopt a policy that recognizes the important role pl.yed by off-label uses of approved drugs and medical devices in the proper administration of health care in this country. FDA originally had intended to adopt the Draft Policy in final form by the end of 1993. However, FDA has now indefinitely postponed further action on its Draft Policy until it has had an opportunity to fully respond to WLF's Citizen Petition. FDA Deputy Commissioner for Policy David Adams told a recent gathering of health care professionals that the issues raised in WLF's Petition are sufficiently "important" that FDA "will not be publishing a final policy statement ... until it responds to the request in the [WLF] petition that the agency change the Draft Policy Statement." While WLF hailed FDA's decision to postpone final adoption of the Policy ~ Statement, WLF is concerned that the threat of FDA enforcement action continues to put a damper on the free flow of vital medical information regarding off-label uses of FDA- approved drugs. WLF has noted, for example, that the great majority of recognized treatments of childhood cancers consists 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 is delayed in reaching other physicians who are treating childhood cancers. Among the issues that FDA will have to address when considering WLF's Citizen Petition are WLF's claims that restrictions on dissemination of truthful information regarding lawful uses of FDA-approved drugs and medical devices violate the First Amendment rights of both providers and would-be recipients of such information, and . that such restrictions are in excess of FDA's statutory authority (which is limited to regulation of "labelling" of drugs and medical devices). WLF is a pro-free enterprise 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. *** 0 For more information contact WLF Chief Counsel Richard Samp, (202) 588-0302.