Bad Ad Program: FDA Aims to Keep Drug Promotion Truthful
If you watch television, surf the Web, or read a magazine, you’ve likely seen prescription drug advertisements. Drug companies promote their products to consumers through these and other media.
However, drug companies promote their products to health care professionals in other ways. Representatives from drug firms market their products in places such as doctors’ offices, hospitals, pharmacies, and at medical conventions.
Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.
The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as they do advertising to consumers, according to the Congressional Budget Office.
Responsible promotional efforts by pharmaceutical companies can give health care professionals valuable information about the latest drug treatments. But when drug promotion is misleading or unbalanced, the Food and Drug Administration (FDA) takes the necessary steps to stop the promotion.
On May 11, 2010, Commissioner of Food and Drugs Margaret A. Hamburg, M.D., sent a letter to health care professionals to announce the launch of the “Bad Ad Program.” Through this new outreach initiative, FDA is asking these professionals to help it make sure that the promotion of prescription drugs is truthful and not misleading.
“This program will help health care professionals recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” says Thomas Abrams, director of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).
Better Information About Prescription Drugs
“We’ve seen promotion that is accurate and balanced and provides good and useful information to doctors and patients,” says Michael Sauers, a group leader in DDMAC. “Having complete and good information will help doctors in the decisions they need to make about treatment options for their patients.”
But not all promotions are accurate and balanced.
“One of the biggest problems is that sometimes the drug reps promote a drug’s effectiveness while playing down the risks,” says Robert Dean, also a group leader in DDMAC. “One tactic is to try to disconnect the known risk from their specific drug by claiming that the risk is seen with other competing products, but not their drug. Or they may claim that the risks of their drug are less likely to occur than shown in clinical trials.”
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