OFF-LABEL USE: Judge Backs Drugmakers In Ruling
A federal judge ruled yesterday that the Food and Drug Administration cannot prevent pharmaceutical companies from distributing scientific information to doctors about the off-label uses of drugs. In what the Washington Post calls a "potentially far-reaching decision," U.S. District Judge Royce Lamberth ruled that the FDA's "ban on the distribution of scientific journal articles and textbooks to doctors violates constitutional protections for commercial speech." The drug-regulating agency also cannot ban continuing medical education lectures on off-label uses of medications (Schwartz, 7/31). "A physician's livelihood depends on the ability to make accurate life and death decisions upon the scientific evidence before them. They are certainly capable of critically evaluating journal articles or textbook reprints," wrote Lamberth in his ruling (Silverman, Newark Star Ledger, 7/31). For its part, the FDA contended that restrictions on off-label touting are necessary so a company will not "promote products by providing incomplete or biased information, or gain approval for a drug for a very narrow use and then promote many other uses through the distribution of favorable scientific information" (Washington Post, 7/31).
The case, brought against the FDA by the Washington Legal Foundation three years ago, has far-reaching consequences because it throws into question a 1997 law set to take effect this fall. The law would only allow off-label promotion of drugs if the agency was conducting scientific research on the off-label uses and was planning to seek FDA approval for the alternative uses. David Young, an attorney with the Washington Legal Foundation, said Lamberth's ruling "may have rendered" the law "meaningless" (Star Ledger, 7/31). The Wall Street Journal reports that the American Association of Advertising Agency said the law was "so restrictive that virtually no companies were going to take advantage of them." Senior vice president of the association, John Kamp, called yesterday's ruling "a major legal victory" because not only does it "lift specific advertising restrictions," but it also shifts "the legal playing field in all drug-advertising lawsuits." He said, "This begins the process where the FDA has the burden of proof in all these communication cases." The ruling said, however, that drugmakers still cannot "distribute internally produced materials to doctors about off-label use, nor can they directly contact doctors or consumers about it" (Sharpe, 7/31).
The Washington Post reports that the FDA "is likely to appeal the ruling." But William Hubbard, a commissioner in the FDA's office of policy, said that "the agency will carefully review the decision and will work closely with the Department of Justice in determining possible courses of action" (7/31).