MMA'S COST CONTAINMENT REQUIREMENT MAY LIMIT DTC ADS

The Medicare Modernization Act's (MMA) requirement that the president notify Congress of rising Medicare expenses and introduce fast-track legislation to contain spending will likely force lawmakers to limit direct-to-consumer (DTC) marketing, consumer advocates say, citing the high cost of advertising and its effect on overall drug spending.

Lawmakers, consumer advocates and academics have long condemned the industry practice of advertising prescription drugs to consumers, arguing that DTC promotions influence patients to seek drugs they do not need and which, in some instances, may do more harm than good. This concern has led various groups to seek a moratorium, if not an outright prohibition, on advertising for newly approved drugs.

But Bill Vaughn, senior policy analyst with Consumers Union, said that the real driver for change will be a provision in the MMA that requires the president to notify Congress seven years before more than 45 percent of Medicare funds come from the general revenue. At that time, which Vaughn said could come as soon as spring 2007, the president would be compelled to introduce fast-track legislation to cut Medicare spending. The requirement is found in the MMA's cost containment provision, Title VIII.

Vaughn believes that the need to cut these costs will put pressure on lawmakers to curb DTC advertising, which costs companies approximately $30 billion annually, leading to higher Medicare costs. When given a choice between reducing ad spending and cutting benefits, Congress will choose to restrict DTC ads, Vaughn said.

A coalition of 225 medical school professors recently endorsed a prohibition on DTC advertising in the pharmaceutical industry, arguing that such promotions only serve to increase the cost of drugs and the number of unnecessary prescriptions. "Prescription drug advertising pressures health professionals to prescribe particular medications, and often the ones that may be less effective and more expensive and dangerous," the coalition said in a recent statement.

The drug industry has argued that DTC ads help educate consumers about new treatments, a claim that was refuted by the coalition.

But PhRMA argues that the benefits of DTC advertising outweigh any costs and may lower Medicare costs in the long run. DTC ads prompt dialogue between patients and their doctors, leading to diagnosis and treatment of many ailments that would not be discovered otherwise, Lori Reilly, PhRMA's VP for policy and research, told FDAnews. These discussions can lead to early treatment of diabetes, high cholesterol, asthma and arthritis, allowing these problems to be treated using medications, instead of more costly surgery and hospitalization.

The medical professors' statement was promoted by advocacy group Commercial Alert, which seeks to limit commercialization. The group is planning to present the statement during an upcoming FDA public hearing on DTC advertising.