Bad Ad Program: FDA Aims to Keep Drug Promotion Truthful
Another problem is overstating the effectiveness of a drug, for example, by saying the drug works in as little as three days, when the majority of patients in studies took three months to show results.
FDA’s DDMAC aims to ensure that all prescription drug promotion is truthful, balanced, and accurately communicated. Promotions it regulates include
- sales representative presentations
- speaker program presentations
- TV and radio advertisements
- written or printed drug promotional materials
Traditionally, DDMAC has monitored prescription drug promotions through
- review of promotional materials submitted by companies
- investigation of complaints about drug promotions
- close observation (surveillance) of drug promotions at large medical conventions
- review of promotion using the Internet
While these efforts are effective, FDA’s ability to monitor promotional activities that occur in settings such as doctors’ offices, local dinner programs, and promotional speaker programs is limited.
“Companies send us their sales aids—the booklets and campaign materials for their drug that the reps are supposed to use in the field when they talk with doctors—and we review those materials,” says Dean. “But we have limited access to the promotional activities in these settings. That’s why we’re asking health care professionals to partner with us in our efforts to stop misleading prescription drug promotion.”
Recognizing and Reporting
Through the Bad Ad Program, FDA is asking health care professionals to recognize and report.
Recognize: Be aware of the many drug advertisements and promotions that they see every day and learn how to distinguish misleading or illegal information.
Report: Help FDA stop violations by reporting activities and messages that may be false or misleading.
FDA will evaluate all the reports it receives. If FDA finds any violations of the regulations, it will take action to stop the misleading promotions.
FDA plans to conduct the Bad Ad Program in three phases. In phase 1, FDA will exhibit the program at medical conferences and partner with medical societies to distribute educational materials. Eight major medical conferences are on FDA’s schedule from May through September 2010. In phases 2 and 3, FDA will expand its collaborative efforts and update its educational materials.