ALTERNATIVE DRUG USES: Judge Overturns FDA Restrictions

      The pharmaceutical industry scored a major victory yesterday when a federal judge overturned a provision of the FDA Modernization Act that restricts drug manufacturers from informing doctors of unapproved uses of medicines, the AP/Bergen Record reports. U.S. District Judge Royce Lamberth deemed the law in violation of drug companies' right to free speech (Schmid, 7/29). Lamberth said, "The government, however benign its motivations, simply cannot justify a restriction of truthful, nonmisleading speech on the paternalistic assumption that such restriction is necessary to protect the listener from ignorantly or inadvertently misusing the information." While doctors are free to prescribe any FDA-approved drug for any condition, the judge's ruling enables manufacturers to more aggressively tout "off-label" uses by distributing studies to doctors. Pharmaceutical Research and Manufacturers of America spokesperson Jeff Trewhitt said that "it would appear the judge's ruling is consistent with the constitutional protection of commercial speech." FDA policy commissioner Peggy Dotzel said, "We'll have to carefully evaluate the decision and determine what we have to do as a follow-up." One year prior to the ruling, Lamberth found the law unconstitutional but "agreed to review his ruling." The law required pharmaceutical companies to meet a list of conditions before disseminating journal articles to doctors, required manufacturers to apply to the FDA for off-label uses before promoting them, required the submission of promotional materials to the FDA before distribution and "required the manufacturer to report semiannually on its promotional activities."

A Word of Caution
      Georgetown University pharmacology chief Raymond Woosley noted that there could be problems with off-label uses of certain drugs. He said, "We see all the time that advertising and promotion of medications exceeds the bonds of scientific accuracy, and you have to address it one way or another. Physicians need to know about off-label applications, but they need balanced information and there is no impartial arbiter" to offer it (Gugliotta, Washington Post, 7/29). Lamberth's ruling does require that the studies provided to doctors by drug companies not be false or misleading, drug companies to "disclose any association between the [drug] company and the researcher" and "whether the treatments detailed in the studies are FDA-approved." Trewhitt noted that manufacturers will still seek FDA approval for off- label uses as it is necessary for advertising purposes (AP/Washington Times, 7/29).