Frist Calls for Moratorium on DTC Drug Ads

Frist: Targeting DTC drug ads.

In early July, U.S. Senate majority leader Bill Frist (R–TN) called for a two-year moratorium on direct-to-consumer (DTC) advertising of new pharmaceuticals. Citing “skyrocketing” use of DTC ads on television, Frist, a cardiac surgeon, said, “This advertising can lead to inappropriate prescribing and fuel prescription drug spending.” Acknowledging that the ads can empower patients by increasing awareness about advances in drug therapies, Frist nevertheless said the ads tend to “oversell benefits and undersell risks,” which can compromise patient safety and care.

Although medtech manufacturers have shown signs of increasing interest in DTC advertising, their product campaigns and expenditures are infinitesimal compared with those of the pharmaceutical industry. And although it looks as though Frist’s current campaign will not target the device market directly, it has the industry’s attention.

Acela's Weagraff: Learning from pharma.

“Device DTC efforts do not have anywhere near the market presence of the pharma industry, where they’re so pervasive,” says Pam Weagraff, founder and principal of Acelera Consulting (North Reading, MA). However, she adds, “The standards set by pharma typically influence what happens on the device side, and smart device manufacturers can benefit by keeping abreast of developments on the drug DTC front, while they build and adjust their marketing programs to accommodate the prevailing guidelines before ever running afoul of the regulators.”

Health Advances' Speers: Dangers in visibility.

Mark Speers, managing director of Health Advances LLC (Weston, MA), says it’s highly unlikely that there will be any call for a moratorium on DTC advertising of medical devices. “Companies in the drug industry have a great deal of exposure as a result of their massive DTC efforts. And while they’ve raised the visibility of their products, they have also raised the visibility of any problems when they occur—particularly those that affect patient safety.

“Fairly or unfairly,” he continues, “in today’s court of public opinion, drug manufacturers often don’t enjoy the same level of approval and confidence as device manufacturers.”

Making his appeal directly to the pharmaceutical industry, Frist asked manufacturers to implement a voluntary two-year restriction on DTC advertising for newly released drugs. He also called for the General Accountability Office (GAO) to undertake a new investigation of FDA’s oversight of prescription drug advertising; how much the pharmaceutical industry is spending on such advertising; and the impact of DTC efforts on patient education, prescription drug usage of DTC promoted products, and healthcare spending.

In a letter to the comptroller general, Frist cited a 2002 GAO report that found that between 1997 and 2001, pharmaceutical industry spending on DTC advertising increased at a much greater rate than outlays for research and development. Frist also noted that during the same time period, the television ad share of DTC pharmaceutical advertising increased from 25 to 64%, and that the best-selling drugs were those most heavily promoted. In calling for a new GAO report, Frist noted that in the three years since the original study, “mounting drug-safety concerns, particularly with regard to newly approved, heavily advertised pharmaceuticals, have renewed the discussion regarding the impact, appropriateness, and effectiveness of DTC advertising.”

Yet, according to TNS Media Intelligence (London), average monthly expenditures for pharmaceutical DTC ads actually decreased by 2% in the first half of 2005, totaling $351 million in contrast to $358 million expended in the first half of last year. TNS reported that pharmaceutical industry analysts had predicted the decrease in part because of “the uproar over Vioxx,” a COX-2 inhibitor that Merck & Co. Inc. (Whitehouse Station, NJ) withdrew from the market in September 2004 due to safety concerns.

The pharmaceutical industry has been quick to respond to Frist’s call. Just days after Frist’s letter was issued, the Pharmaceutical Research and Manufacturers of America (PhRMA; Washington, DC) issued a statement asserting the “invaluable role DTC advertising plays in informing physicians and patients about new life-saving medicines” and dismissing any suggestion of a link between advertising and drug prices. Nevertheless, the industry association reported that it was already at work on developing voluntary principles to help advance its “educational mission.”

PhRMA's Tauzin: Organizing self-government.

In early August, PhRMA president and CEO Billy Tauzin announced that the industry’s guiding principles on DTC advertising had been approved by the group’s board and would take effect in January 2006. In making the announcement, Tauzin said, “With these principles, we commit ourselves to improving the inherent educational value of advertisements. Patients need accurate and timely information and should be encouraged to discuss diseases and treatment options with their physicians.  These principles will help us reach that goal.” Key elements of PhRMA’s new guidelines include the following.

• Companies should spend an appropriate amount of time educating health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign. In determining “an appropriate time,” companies should consider the importance of informing patients about the new medicine, the complexity of its risk-benefit profile, and healthcare professionals’ knowledge of the condition being treated.

• Companies should submit all new DTC television advertisements to FDA before releasing them for broadcast.

• DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

• DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports a responsible dialogue between patients and healthcare professionals.

• Companies should continue to educate healthcare professionals as additional valid information about a new medicine is obtained from all reliable sources.

Although Frist welcomed PhRMA’s principles, he said he was disappointed that the guidelines did not go further and propose a moratorium on DTC advertising of newly approved drugs. Noting that he hopes individual pharmaceutical manufacturers “will seriously consider such a measure,” Frist also said he looks forward to reviewing the comprehensive GAO study and intends to closely monitor the situation to assess whether PhRMA’s voluntary guidelines and FDA actions to revise the agency’s guidance go far enough in “stemming the tide of often unbalanced and misleading DTC advertising or whether legislative remedies are necessary to put patient safety first and help control prescription drug costs.”

Manufacturers were quick to embrace the new PhRMA guidelines. On the day the guiding principles were released, Johnson & Johnson (New Brunswick, NJ) and Merck reported that they planned to follow the recommendations. Pfizer Inc. (New York City) also announced its intent to abide by the guidelines and went further to make additional changes to its advertising policy, including the voluntary implementation of a six-month minimum moratorium on DTC advertising for new drugs.

Meanwhile, newly confirmed FDA commissioner Lester Crawford, DVM, PhD, commented that the PhRMA guidelines are a step in the right direction. But he added that FDA plans to “watch them carefully and reserve judgment.”

Canon Communications LLC

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