Regulation of Rx Drug Ads is ‘Necessary,’ Former FDA Officials Say
FDA regulation of direct-to-consumer advertisements is "necessary" and should not be compromised by concerns over infringing upon the First Amendment rights of commercial speech, William Schultz and Michael Taylor, former deputy commissioners for policy at the FDA, write in a Washington Post opinion piece. Pre-market review of prescription drug health claims has been "widely applauded as vital to public health," but the FDA has put those public health protections in jeopardy as the agency has requested the "public and the industries it regulates to supply it with arguments about whether the First Amendment ... limits the FDA's power over advertising," Schultz and Taylor write. The move is a "direct outgrowth" of an effort by "conservative judges, academics and advocacy groups" who claim that the First Amendment limits the government's power to regulate direct-to-consumer advertising, "even when important public health interests are at stake," the authors say. Schultz and Taylor refer to a 1994 law that loosened regulation of the dietary supplement industry, noting that the law has resulted in consumers being "inundated with unsupportable claims" about those products. Schultz and Taylor conclude: "Americans take it for granted that drug and other health-product companies should be required to demonstrate the safety and effectiveness of their products before they promote them. ... These common-sense assumptions are now being questioned by government lawyers who argue that the First Amendment to the Constitution severely limits the government's role in monitoring commercial speech about products with serious health consequences. It is hard to imagine that this was the intent of the Founders in 1789 or is in the public's interest today" (Schultz/Taylor, Washington Post, 5/28).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.