Drug Co.'s Work To Fend Off Gov't Regulation Of DTC Ads Amid Mounting Criticism

One by one, the consumer groups stood up to tell the Food and Drug Administration at a public hearing on Nov. 1-2 that a moratorium should be placed on direct-to-consumer advertising of prescription drugs.The ads are "misleading or dangerous," said Peter Lurie, deputy director of the Public Citizen's Health Research Group, to the panel of FDA officials who will decide if the rules governing DTC ads should be changed.Such ads minimize "the risk and severity of side effects," said Alex Sugerman-Brozan, director of the Prescription Access Litigation Project, a consumer health-care coalition.And the ads create a "culture of disease and fear" by trying to "convince people that they are ill, and to invent new classes of illness," said Gary Ruskin, executive director of Commercial Alert, a nonprofit group that seeks to reduce the amount of commercialization in American life.In response to such growing criticism and consumer concern about drug safety, the FDA could impose a moratorium for a specific amount of time, or it could change the existing rules to require a better balance between a drug's benefits versus risks in each ad. The FDA may also require drug makers to submit ads in advance for its approval, something that is done voluntarily under current rules.Although the FDA will not signal its intentions, all options are on the table. "We did not dismiss anything at the meeting," said Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications. "Our objective will be, how can we do what is best for the public health, and we will do this without any preconceived notions of where we are going."The fact that the FDA is reevaluating the regulations governing DTC ads was hardly welcome news to the advertisers, pharmaceutical companies and lobbyists seated in the room, who have good reason to believe that the ability to market prescription drugs to consumers is under siege. U.S. drug companies spent $4.1 billion advertising prescription drugs last year, per Nielsen-Monitor Plus. Naturally, media sellers would be affected by a moratorium or curtailing of such ads. Last year, broadcasters alone took in $3 billion of that total ad spend.What worries the defenders of DTC ads is that some change in the rules governing the ads is likely given the mounting pressure on the FDA, which is largely a result of growing public concerns about drug safety. Studies linking prescription painkillers known as cox-2 inhibitors—like Vioxx and Celebrex—to cardiac problems have prompted critics to question whether prescription drug ads drive up the number of prescriptions and health-care costs. The FDA asked Pfizer to remove the painkiller Bextra from the market in April. Pfizer voluntarily suspended its advertising for Celebrex last December.The FDA is on the record supporting some aspects of DTC ads. For example, Janet Woodcock, the FDA's deputy commissioner for operations, said at a September 2003 public hearing that such ads can increase awareness about diseases, and help drive patients who might otherwise avoid treatment to see their doctors. "The impact of direct-to-consumer advertising is neither wholly negative nor wholly positive," Woodcock said at the time. "Given that [DTC advertising] is likely to remain, an ongoing question is, 'Can it be made better or more useful?'" As a result, some in the ad industry think limitations are more likely than a moratorium. "My expectation is if they try to do anything, they will try to do restrictions rather than a rollback," said Dan Jaffe, evp for government relations of the Association of National Advertisers. "A rollback would raise serious First Amendment issues that we do not believe the FDA can surmount."Still, defenders of the ads took the threat of a moratorium very seriously in their testimony to the FDA. "DTC ads stimulate conversations with doctors [and] lead to better prescribing and better patient compliance," said John Kamp, executive director of the Coalition for Healthcare Communication, which represents medical marketing agencies and publishers. "Our current scheme is not broken, so let's be careful how we tinker."Wally Snyder, president and CEO of the American Advertising Federation, was more blunt. "Do not impose a moratorium," he told FDA regulators. "If a drug is not ready, by all means keep it off the market. Regulate the drug, but do not impede the flow of truthful information."Congress is considering its own restrictions. Rep. James Moran, D-Va., introduced a bill that would prohibit broadcasting erectile dysfunction ads from 6 p.m. to 10 p.m. The bill seeks to prevent exposing children to ads for Cialis, Levitra and Viagra. Other bills would remove the tax deduction for the cost of preparing drug ads and require that ads for drugs determined to impose an "unreasonable risk" must include a statement that says so.Comments by Senate Majority Leader Bill Frist, who said drug ads increase health-care costs and that companies should put a two-year delay on advertising new drugs, have made the advertising and pharmaceutical industries particularly nervous. "A lot of direct-to-consumer advertising is misleading," Frist said on July 1. "This ... advertising can oversell hope. It could oversell results. And it can also undersell the risk.""When the Senate majority leader spends an hour on the floor criticizing DTC advertising, we would be remiss not to take it seriously," said Jim Davidson, executive director for the Alliance for American Advertising, a coalition of drug companies and ad and media lobby groups.Drug companies are taking no chances. In a testimony to the FDA on Nov. 1, Astra-Zeneca wrote that it would support legislation requiring drug makers to submit all prescription drug ads to the regulatory agency for review prior to public dissemination, provided the FDA could review the ads quickly enough. Critics for and against DTC ads charge that the FDA, with only a staff of 40 people to review ads, lacks the resources to handle any mandatory pre-screening. They further complain that it can take so long from the time an ad first appears to the FDA taking an enforcement action—up to 177 days, by one Congressional committee estimate—that an ad has often run its course before a drug maker receives an FDA warning letter.Drug companies have voluntarily taken steps to ease the pressure. The drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, adopted a set of guiding principles for DTC ads in July. Before that, Bristol-Myers Squibb decided to cease advertising directly to consumers during a drug's first year on the market. PhRMA principles include talking with doctors before launching a prescription drug campaign and promoting health awareness in ads. There has also been a change in how some drug companies convey risk information in their ads. Instead of using a voiceover to mention a long list of risks, which is the way many broadcast drug ads handle the side-effects, AstraZeneca featured a husband and wife discussing the risk of side-effects in a recent Nexium ad—a better way to communicate risk information in ads, some say. Ruth Day, director of the Medical Cognition Laboratory at Duke University, told the FDA that when people in test studies watch ads, they tend to remember the beginning and the end, but not what comes in the middle. Because many DTC ads place the risk information in the middle of the spot, changing where and how that info is conveyed can better communicate the side effects, she said."We saw a 100 percent increase in people's knowledge of side effects when they changed the location," Day said.Other drug makers have also made changes. By the end of this year, Pfizer will tell viewers of its broadcast, print and Internet ads that a patient's doctor may recommend alternatives to a drug, such as diet and exercise. "We can do more to increase the proven public health benefits of DTC advertising," Pfizer U.S. Pharmaceuticals president Pat Kelly told the FDA. "You will see ... communication of information in clearer language, better balance of risks with medicinal benefits and more relevant information that research tells us engages and motivates viewers."Kelly also said Pfizer will launch a separate public health campaign that will focus on disease prevention and increasing patient dialogue with doctors without mentioning any specific drug. Pfizer will spend an average of what it would cost to market one drug, but declined to name a specific figure.But consumer groups consider these industry actions to be window-dressing. Lurie, of the Public Citizen's Health Research Group, gave the FDA an example of an ad he thought was inappropriately targeted at teenagers. Ads for the acne drug Differin, made by Galderma Laboratories, have appeared on MTV and the Internet, and refer teens to a Web site that offers two free music downloads if they sign up on the site, seven free downloads for filling a prescription and 10 free downloads for refilling a prescription."This advertisement essentially pays teenagers to convince adults to procure this drug for them," Lurie told regulators.Consumer groups also complain that so called "disease awareness" ads, which are meant to inform patients about illnesses, are nothing more than product promotion messages. Sugerman-Brozan, of the Prescription Access Litigation Project, said Pfizer's "Why Live With Depression" ad campaign for its antidepression drug Zoloft is an example of why the FDA needs to regulate such ads. In the spot, actress Lorraine Bracco talks about her battle with depression but mentions no drug. The ad then refers people to the Web site www.depressionhelp.com, and it is there that Bracco says her doctor put her on Zoloft."The link between the original supposedly non-promotional ad and the Web site promoting Zoloft belies the claim that disease awareness ads are some benign form of public education," Sugerman-Brozan said. Ruskin, of Commercial Alert, argues that DTC ads "encourage people to see their problems as diseases that require medication.""The advertising industry succeeds insofar as it makes people feel like they want to buy the drug advertised," Ruskin told the FDA. "That's marketing. It is not education."

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Drug Co.'s Work To Fend Off Gov't Regulation Of DTC Ads Amid Mounting Criticism

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