Hello, my name is Mike Sauers. I'm a Team Leader in the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research. I am happy to be here today as part of the FDA's Expert Commentary Series on Medscape to talk about the FDA's Bad Ad Program.
As healthcare professionals, prescription drug advertising and promotion is all around us. Whether you see drug reps on a daily basis, read medical journals for the latest research, or simply attend medical conventions, prescription drug promotion is virtually inescapable. While responsible promotion can inform and educate, misleading promotion has the potential to negatively influence treatment decisions and may put patient's health at risk.
This raises the question: Do you think you could identify a misleading prescription drug advertisement if one came across your desk? Would you know if a sales representative's pitch overstated the efficacy of a drug or minimized its risks? We at the FDA think that you can and have created the Bad Ad program to make it easy for you to report such violations to us so we can put a stop to it.
My office within FDA is responsible for ensuring that prescription drug promotion is truthful and not misleading. Over 78,000 promotional pieces are submitted to us every year and we regularly put a stop to the misleading promotion we discover. However, FDA can't be everywhere and see everything. This is why we created the Bad Ad program. The Bad Ad program's goals are to educate healthcare professionals to recognize misleading prescription drug promotion and encourage prompt reporting to the FDA. Simply, FDA is asking you to be aware of the many promotional messages you hear every day. Take a moment to consider the information presented to you. If you suspect it may be misleading, report it to FDA by calling 877-RX-DDMAC (877-793-3622) or sending an email to BadAd@fda.gov
Misleading messages can be embedded in any type of promotional piece, whether it is a sales aid or journal ad, a company-paid speaker's presentation, or even verbal statements made by a sales representative. But what is it about a message that makes it misleading? The most common problems we at FDA see in promotion include:
Overstating the efficacy of a drug. One example would be if a sales representative said, "Drug X is effective in 90% of patients" and you learn later that clinical trials showed efficacy in only 50% of those treated with the drug.
Omitting or minimizing the risks of the product. A presentation about a prescription drug that informs about the drug's benefits but not its risks is a common example of this violation.
Promoting the use of a drug in a wider range of patients than it has been approved for or for a completely new use not in the FDA-approved product labeling. This off-label promotion is very concerning because the drug has not been approved as safe and effective in these patients or conditions.
Making unsubstantiated comparisons between drugs. To make comparisons, drugs must generally be tested against each other in head-to-head trials designed to distinguish a difference between them.
Reporting misleading promotion to the Bad Ad program is simple. There is no holding on the line or sending emails to an unstaffed mailbox. Your report will be reviewed by an FDA staff member who will ensure that your report is investigated. And while you can report anonymously, it is helpful to provide contact information so that FDA can follow up with you if more information is needed to determine whether the messaging is misleading and to put a stop to it.
Since the Bad Ad program launched in May 2010, healthcare professionals have responded and helped put a stop to a number of misleading promotions by reporting them to FDA. A misleading Website, a YouTube video, verbal statements from a drug rep, even a violative promotional magnet are all examples of misleading promotion that healthcare professionals helped stop by submitting a report to 877-RX-DDMAC or BadAd@fda.gov.
While this has been a great start, it is just the beginning. In the coming months, we plan to expand the Bad Ad program to include a Web-based continuing education program, and to continue working with medical societies and medical, nursing, and pharmacy schools to spread the word about how to recognize and report misleading drug promotion.
Most important, we ask that you continue to help us to protect the public's health by taking a moment to consider the promotional messages you encounter. If you suspect that they are misleading, report them to FDA at 877-RX-DDMAC or BadAd@fda.gov.
We encourage you to learn more about the Bad Ad program and misleading prescription drug promotion by visiting our Website.
Thank you for your help and for taking the time to listen today.