FDA Plans to Review Direct-to-Consumer Ad Policy

With the number of prescription drug commercials on television "skyrocket[ing]," the FDA plans to "explore whether the ads are causing more harm than good," the Wall Street Journal reports. The FDA first allowed drug companies to air direct-to-consumer advertising in 1997, and since then, spending on television ads for prescription drugs has more than quadrupled, jumping from $220 million in 1996 to $1.13 billion in 1999, according to IMS Health and Competitive Media Reporting. However, the number of "complaints" from patients and doctors about the ads also has increased, with doctors saying that they are often "bombarded" by patient requests for "the latest -- and usually most expensive -- drugs." Beginning a "long-planned" review of the advertising policy, the FDA intends to study whether pharmaceutical ads "confuse consumers and adversely impact the relationship between patients and their health-care providers." To that end, the FDA plans to commission two surveys, one of patients and one of doctors, to determine whether the agency should change, rescind or maintain the 1997 policy. The FDA expects to complete the studies by the end of the year. Nancy Ostrove, an official with the FDA's Division of Drug Marketing, Advertising and Communications, said that the agency hopes to learn whether the ads have led to "inappropriate prescribing" and patients "getting drugs they shouldn't be getting." According to critics of direct-to-consumer advertising, while the FDA likely will not "reverse course" on the issue, the review will provide a "platform to demand that the advertising be reined in."

Many doctors and insurance companies "contend" that "flashy, well-produced ads" have sent patients "in search of the latest medications even when they don't need them," often prompting "harried" physicians to prescribe drugs "rather than battle -- and possibly lose" -- their patients. "For the doctor, it's a minute and a half to write out the prescription and let the patient go home happy, or 30 minutes of sitting there and explaining why they won't," Nancy Chockley, president of the National Institute for Health Care Management Research and Educational Foundation said. In addition, with many covered under managed care plans, patients often have "little incentive" to avoid "high-price" medicines. "I can't tell you how many times I've said to a patient, 'I'm sorry, I'm going to prescribe a very expensive drug,' and they just say, 'That's all right, doctor, I only pay $10,'" former American Medical Association President Dr. Thomas Reardon said. Although critics of television drug ads have "mixed feelings" on the issue, believing that it is "too late" to stop the ads because patients have come to accept them. However, most critics at least "want [the ads] to give more information about drug safety." John Golenski, executive director of
RxHealthValue, said, "We're very concerned that 30-second ads simply don't have enough time to disclose the amount of information necessary for patients to understand these drugs" (Adams, Wall Street Journal, 3/28).