Tobacco Documents Online

I J • • September 30, 1994 both providers and recipients of such information. Although the FDA has not attempted to interfere with off-label uses of FDA-approved drugs and medical devices, within the past two years the agency has taken steps to interfere with the dissemination of truthful information about off- label uses. In one particular case, FDA blocked a manufacturer's attempt to distribute to doctors a medical textbook simply because the textbook contained truthful information regarding generally-accepted off-label uses of the manufacturer's cancer-treating drugs. As the Washington Legal Foundation's (WLF) offensive against FDA's off-label use policy approaches its first-year anniversary, it finally looks like a federal court will have the opportunity to deliver a dose of reality to one or the other of the two adversaries. The WLF is a Washington, D.C.-based legal advocacy outfit that relishes tangling with government agencies who interfere with the rights of business interests to be about the business of free filed a " C i t i z e n s Petition" with FDA last O c t o b e r demanding that FDA rescind its November 1992 draft p o l i c y statement on dissemination of off-label use information. WLF Off-Label Use Suit Heats Up enterprise. The WLF originally "They must think we're dopes. They've been taking comments on this issue for three years and then after we sue them- they ask for more time to get more comments. The FDA knows full well that it has in place a policy that inhibits the flow of truthful information about off-label uses of drugs and devices they have allowed on the market. Basic honesty requires FDA to own up to that policy in court. We're going to give them that opportunity." The crux of the WLF argument is that the FDA's restriction on the dissemination of truthful information regarding off-label uses of drugs and medical devices violates the First Amendment rights of Food & Drug Insider Report Richard Samp WLF Chief Counsel Volume 4, No. 18 F D A regulations require FDA to answer c i t i z e n petitions withi.r. 6 months or else by law a petition is deemed to be denied. The FDA never responded to the WLF petition, and, three months ago (June 13) the WLF filed suit in federal district court in Washington, D.C., to have the FDA draft policy statement invalidated.

• • • In a bizarre effort to buy time, the FDA's erstwhile Deputy Commissioner Michael Taylor whipped off a one-page letter to the WLF asking for additional time to respond to the WLF petition -- one month after WLF had sued FDA! The FDA brain trust said they wanted to publish notice of the WLF petition in the Federal Register, get comments on it, and then respond to the WLF petition. Although they had received the WLF petition nine months earlier, Deputy Commissioner Taylor 'fessed up that, "The agency initially planned to publish [such a] notice earlier, but was unable to do so due to other agency priorities." The WLF slam-dunked the agency's request to postpone the FDA policy's day of reckoning in court in a scathing July 21 press release, essentially telling the agency to put up or shut up; i.e., revoke the policy or see you in court. The FDA apparently got the message and filed a Motion to Dismiss the WLF lawsuit in early August. This past week the WLF responded to the FDA motion with a 43-page Answer opposing the FDA's Motion to Dismiss. Oral arguments on the two side's competing motions are likely to be heard within the next few weeks. In support of WLF's legal position, an amicus brief was filed by the Media Institute on behalf of the Association of American Publishers, the Radio and Television News Directors Association, and the Thomas Jefferson Center for the Protection of Free Expression. After almost a year's wait, the pending court action should finally set in motion a First Amendment legal confrontation between FDA and WLF that very likely will eventually be decided by the Supreme Court. The WLF has been eagerly awaiting its day in court - the FDA has taken every opportunity to duck the issue. FDIR's bet, take WLF and give the points.