OFF-LABEL DRUG USE: New Rules Mean New Ads in the Offing
A recent ruling by a federal judge could create "a new world order" for pharmaceutical companies interested in promoting off-label uses for their drugs, American Medical News reports. On July 28th, U.S. District Court Judge Royce Lamberth struck down the FDA's prohibition of off-label marketing of drugs, calling it "an infringement on First Amendment protections given to commercial speech." Eli Lilly has already begun instructing its sales representatives to re-promote its osteoporosis drug, Evista, as a breast cancer prevention agent, a move the FDA had previously prohibited. Observers disagree on the ramifications of the ruling. Some, like Pharmaceutical Research and Manufacturers Association's Jeff Trewhitt, believe it will enable pharmaceutical companies to disclose the best possible use for their drugs. "It simply confirms the right of a company to give a reprint of a medical journal article to a doctor as long as it is not false or misleading...and [the company] notes that the application does not have FDA approval," says Trewhitt. On the other hand, some are concerned the ruling creates a "free for all" that could endanger a patient's health. "You can't walk into a crowded theater and yell, 'Fire!'" said Amy Allina, the National Women's Health Network's program and policy director. "But this decision is the equivalent of walking into a crowded hospital ward and yelling, 'Cure!'"
Anatomy Of A Ruling
Judge Lamberth's ruling has its roots in a 1994 lawsuit filed by the Washington Legal Foundation against the FDA, in which the "free-market think tank" asserted that an FDA policy "preventing [drug] companies from sharing unsolicited off-label use information with doctors" was a violation of the First Amendment. While that case was "winding through the system," a provision in the FDA's 1997 Modernization Act took effect that allowed drug companies to distribute off-label information from scientific journals, if it was "balanced and clearly marked as 'off-label.'" Lamberth's ruling last month upheld that provision, calling the FDA's old policies "paternalistic" and akin to "constitutional blackmail." Trewhitt thinks drug companies will "react slowly" to the ruling, as they do not want to confront the FDA "until the landscape becomes clearer." The FDA has two months to decide whether they will appeal the July 28th ruling. If the FDA loses the appeal, speculation abounds that the agency would next look to the Supreme Court for a final say in the matter (Stapleton, 8/23 issue).