FDA Mulls Change to US Drugs Ad Code After Public Hearing

24 September 2003

America’s Food and Drug Administration will draw up new guidelines for direct-to-consumer drug ads after a two-day public hearing.

The forum, which concluded Tuesday, featured the findings of various studies of DTC advertising. The FDA intends to use the data to inform its regulatory approach as it plans new guidance on the subject later this year.

Critics of DTC ads claim they fail to give an accurate portrayal of the risks attached to prescription medicines, focusing instead on the benefits. They also argue that consumers do not know enough to understand the advertising fully. Supporters, however, insist that DTC ads educate the public and aid patients’ relationships with doctors.

Remarks made by Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, indicate that the regulator is not considering an outright ban on advertising prescription drugs. At the start of the hearing, she insisted DTC was “likely to remain”, adding: “The genie is already out of the bottle.”

She continued: “The phenomenon must be seen in the larger picture of the evolution of the patient and consumer's role in their own health. DTC promotion is neither wholly negative nor wholly positive.”

However, the FDA is worried about some aspects of prescription drug advertising. “It is of some concern,” Woodcock declared, “that an ad would make an individual so confident as to demand a certain drug, or to doctor-shop until they found a physician willing to prescribe that medicine.”

Despite the FDA’s concerns, Patrick Kelly, president of stateside pharmaceuticals for Pfizer, is convinced DTC ads are a good thing: “The unspoken truth about advertising of medicines,” he argued, “is that it constitutes one of the largest and most successful public health information campaigns in US history.”

Data sourced from: AdAge.com; additional content by WARC staff