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. WLF9S DOCK]ET Li,tigati,on Update WASHINGTON LEGAL FOUNDATION® 2009 Massachusetts Avenue, N.W. Washington, D.C. 20036 ER22, 1M • . WLF OPPOSES FDA EFFORTS TO DISMISS FIRST AMENDMENT LAWSUIT (Washington Legal Foundation v. Kessler) The Washington Legal Foundation (WLF) today urged a federal judge not to dismiss a WLF challenge to Food and Drug Administration (FDA) policies that severely restrict the free flow of truthful information regarding off-label uses of FDA-approved drugs and medical devices. WLF argued that its suit raises important First Amendment issues and thus should not be decided based on the procedural claims raised by FDA. WLF filed its suit, Washington Legal Foundation v. David Kessler, in the U.S District Court for the District of Columbia last June. WLF argues that FDA's restrictions violate the First Amendment rights of both providers and recipients of information about off-label drug uses. FDA responded to the suit by filing a motion to dismiss the case for a variety of procedural reasons, but carefully avoided addressing the merits of WLF's First Amendment claims. FDA argues that WLF lacks standing to challenge FDA policies, that the case is not yet ripe for review, that WLF failed to exhaust its administrative remedies before filing suit, and that the federal courts lack jurisdiction to second-guess FDA enforcement activity. In its response to the motion to dismiss, WLF vigorously contested each of FDA's claims. WLF noted in particular that FDA's policies on off-label drug use are severely limiting the ability of doctors to receive up-to-date information on advancements in medical technology and thus that immediate judicial review of FDA's policy is critical. The case is pending before Judge Royce Lamberth, who is expected to issue a ruling on the motion to dismiss within the next two months. WLF filed the suit on behalf of doctors and medical patients who wish to receive information about off-label uses of FDA-approved drugs and medical devices. The suit alleges that FDA's efforts to block their receipt of such information violates their First Amendment rights. 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 devices. However, within the past three 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 book 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," which 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 drugs and medical devices. WLF filed a "Citizen Petition" with FDA a year ago, asking 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 asked 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 failure to respond to that petition prompted WLF's lawsuit. WLF's lawsuit requests that the federal courts grant WLF the relief it sought in its Citizen Petition. The lawsuit contends that FDA is violating the First Amendment by prohibiting truthful speech that serves important medical purposes. "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 response to FDA's motion to dismiss. "In moving to dismiss the case on procedural grounds, FDA is trying desperately to avoid having to address our First Amendment concerns. We find that troubling; responsible government agencies ought to welcome an opportunity to find out from the courts whether they are abiding by First Amendment norms," 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. *** 40 For further information, contact WLF Chief Counsel Richard Samp, (202) 588-0302.