FDA Hears Recommendations on Regulations for DTC Drug Ads
FDA on Tuesday began two days of hearings to determine whether and how direct-to-consumer advertising of prescription drugs should be regulated, the Los Angeles Times reports.
According to Robert Temple, director of medical policy at FDA's Center for Drug Evaluation and Research, the agency is seeking comments from drug company executives, university researchers, consumer advocates and medical experts on methods to better convey complicated medical information through advertisements. Temple added that there are no specific plans to implement new regulations or guidelines (Murphy, Los Angeles Times, 11/2).
Ruth Day, an associate professor at Duke University who studies consumer understanding of drug ads, said information about drug risks must be presented in a more consumer-friendly format and displayed more prominently in ads. "The risk information is physically present, but functionally absent," Day said. She noted a 2005 study that found information about a drug's benefits in ads was on average presented at a sixth-grade reading level, while risk information was at an eighth-grade level (Higgins, Washington Times, 11/2).
In addition, Day said that after reading or viewing a drug ad, "80% of people can recall what a drug's benefits are; 20% can recall what the side effects are." She said, "We need to improve the cognitive accessibility of risk information" (Los Angeles Times, 11/2).
Gary Stein of the American Society of Health-System Pharmacists recommended that "rapid-fire" delivery of risk information about drugs be slowed and on-screen text be added to make the information easier to follow.
AstraZeneca in written testimony called for mandatory FDA review of ads before they are released (Henderson, Boston Globe, 11/2). AstraZeneca's proposal recommends FDA be allowed to suggest changes to ads that are found to be misleading or to not provide enough information about drug risks and benefits. The company added that FDA would need to increase funding and staffing to review ads quickly (Baltimore Sun, 11/2).
Tony Zook, senior vice president of commercial operations at AstraZeneca, said, "We think this is a logical next step."
John Kamp of the Coalition for Healthcare Communication warned FDA about micromanaging drug ads (Boston Globe, 11/2). Kamp said drug ads should not be held to a stricter standard than other products, adding, "Cars, like drugs, are recalled for safety reasons. Cars, like drugs, have safety issues. It would make no more sense to ban drug ads than it would to ban car ads. Such schemes are undermining the very integrity of the drug approval process and need to be rejected outright."
Pfizer President J. Patrick Kelly said, "Informed dialogue between patients and health care professionals is the single most important element of health communications. We believe that [DTC] advertising is an important and effective channel for this communication. It helps patients work with their health care professionals to make important decisions about their health" (Los Angeles Times, 11/2).
Marlene Tandy -- senior counsel for Johnson & Johnson, who was representing the medical device trade group AdvaMed at the hearing -- opposed AstraZeneca's proposal, saying, "It's an option. We don't think it should be mandatory" (Boston Globe, 11/2).
FDA Deputy Commissioner for Operations Janet Woodcock said, "A lot has happened in the last decade with [DTC] advertising, and we believe it's time to receive additional input. It's critical, from a public health standpoint, that the advertisements are truthful and balanced."
Temple said, "We think [DTC advertising] is legal under law, but we still get to describe its content and regulate its content. We want to hear from people about how to do that, especially if they have data" (Los Angeles Times, 11/2).