Influential Democrat Calls for Ban of Certain New Drug AdsDec 9, 2008 | Parker Waichman LLP
Speaking at an industry conference yesterday, Representative Henry Waxman—the soon-to-be head of the House Energy & Commerce Committee—is looking to give more power to the U.S. Food and Drug Administration (FDA) when it comes to airing direct-to-consumer (DTC) drug advertisements, says Pharmalot. Waxman, a California Democrat, is working to have these ads banned when a new drug hits the market, reports Reuters. Such drugs are often available to consumers before a medication’s risks have come to full light, which can place American consumers in danger of a drug’s unrevealed adverse effects.
Waxman is planning on pursuing this issue, among others, including other healthcare-related matters, said Reuters, when the new Congress meets in January. Quoting Waxman at the conference, Reuters reported, "It is in these first few years of a drug's life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood."
Waxman spoke at a conference sponsored by watchdog group The Prescription Project, a known critic of industry marketing. The Prescription Project recently alleged that device makers were illegally advertising on the popular video-sharing Website YouTube.com and also petitioned the FDA to require three device makers—Abbott Labs, Medtronic, and Stryker—to withdraw their illegal YouTube.com video ads, which were missing federally mandated warnings.
In 2007, Waxman supported Congress in its efforts to allow the FDA to ban television ads for some new drugs for up to three years, but only if officials found the ban was in the best interest of public health, said Reuters, noting that if implemented, the ban would be decided on a case-by-case basis. "That concept makes a great deal of sense and can provide FDA an important tool to protect the public health," Waxman said, according to Reuters. Unfortunately, that effort failed because some lawmakers fought the move arguing that, if passed, it would violate freedom of speech, reported Reuters, which added that, instead, Congress allowed FDA some added weight to assess fines on companies found “running false or misleading promotions.”
Drug marketing campaigns have long been criticized for exaggerating benefits, playing down side effects, and creating an environment in which excessive prescribing practices are the norm, said Reuters. But, notes Reuters, drug makers claim that the ads are helpful, better enabling consumers to learn about new treatment options, adding that voluntary guidelines have been followed by some drug makers which urge manufacturers to hold off on such advertising for "an appropriate amount of time" to allow them to discuss the emerging medications with physicians before ads run.
At a U.S. Senate Special Committee on Aging Chairman Herb Kohl (Democrat-Wisconsin) held hearings to determine if DTC advertising adequately explained any health risks associated with medical devices. At the hearing, reports The Prescription Project, one expert testified that, “78 percent of surgeon respondents surveyed believed their patients were ‘confused or misinformed about the appropriate treatment for their condition based on an advertisement.’”