Government Report: February 1, 2007

Contents:

DTC Study Criticizes Pharmaceutical Advertising
A new study completed at the University of California, Los Angeles, criticizes the pharmaceutical industry for their marketing practices and calls on lawmakers to require the industry to provide more risk information during advertisements. The study claims that direct-to-consumer ads on television do not effectively convey information about product risks and benefits and have "virtually no educational value." The research was based on television ads that aired in the summer of 2004 and was published in the January-February edition of Annals of Family Medicinealongside an editorial by Dr. David Kessler, former commissioner of the Food and Drug Administration, titled "Direct-to-Consumer Advertising: Is It Too Late to Manage the Risks?" Dr. Kessler said that "the amount spent promoting drugs for conditions of varying severity begs the question of whether the industry truly is acting for the public benefit." Multiple studies show that consumers benefit from receiving information about new medical treatment options. The AAF supports FDA regulations already in place to ensure truthful and effective marketing and notes that self-regulation practices, including marketing guidelines from the Pharmaceutical Research and Manufacturers of America, are already tougher than what the government requires. We argue that this research misstates the role that pharmaceutical advertising plays in educating consumers. Additionally, because the study was based on ads that aired in 2004, the research fails to reflect the many positive changes made in DTC advertising over the past two and a half years.
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Two Bipartisan Drug Safety Bills Expected to Be Reintroduced in Senate
Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Ted Kennedy, D-Mass., and Ranking Member Michael Enzi, R-Wyo., are expected to reintroduce legislation that would overhaul the Food and Drug Administration’s rule-making authority over direct-to-consumer advertising. The bill, first introduced in 2006, would give the FDA power to impose a moratorium of up to two years on new DTC advertising and require preclearance of ads for new drugs by the agency. The AAF opposes the bill because of these provisions. Industry guidelines already in place call on pharmaceutical companies to first spend resources on educating medical professionals before advertising products to the public.

At the same time, Sens. Christopher Dodd, D-Conn., and Charles Grassley, R-Iowa, are expected to reintroduce legislation that would modify the Food and Drug Administration’s safety review system for previously approved drugs but would not impose advertising moratoriums or require preclearance of ads. The bill, the Food and Drug Administration Safety Act of 2007, would create within the FDA the Center for Postmarket Evaluation and Research (CPER), charged with monitoring the public reaction to new drugs after they have reached the marketplace. CPER would have the authority to take corrective action if there are concerns about the safety of a drug.
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Sen. Brownback, FCC Chairman Martin to Convene Food Marketing Task Force
Senator Sam Brownback, R-Kan., and Federal Communications Commission Chairman Kevin Martin will convene a task force next month to discuss voluntary steps the food and advertising industries might take to combat obesity in children. FCC Commissioners Michael J. Copps and Deborah Tate Taylor, Federal Trade Commission Chairman Deborah Platt Majoras and Sen. Tom Harkin, D-Iowa, have indicated they will participate in the forum. Representatives from General Mills, McDonald’s, PepsiCo, Kraft Foods, Coca-Cola, Walt Disney, Viacom, Discovery Channel, Telemundo and the Black Family Channel are also expected to attend, as well as representatives from health groups and consumer groups. Sen. Brownback, who has announced he will seek the Republican nomination for president in 2008, said he is "hopeful that this task force will forge a voluntary, public-private partnership to effectively address the pressing issue of media and child health."
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FTC Chairman Majoras Calls on Advertisers to Improve Food Marketing
Federal Trade Commission Chairman Deborah Platt Majoras called on advertisers to make several resolutions this year, saying the industry should "trim the fat in marketing to kids" as well as "enhance the exercise regime of self-regulation." Speaking at a recent conference, she praised the recent changes to CARU guidelines as well as the new food and beverage initiative. Majoras reiterated her stance that she is not interested in assigning blame for the problem of childhood obesity and called on "all segments of society...to take a hard look at what we can do to improve our children’s health."
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