Although the US Food and Drug Administration (FDA) doesn’t vet pharma ads, it has a “Bad Ad” program that now has an interactive quiz to help in the reporting of misleading information in pharmaceutical promotions.
The FDA’s Bad Ad Program is an outreach program designed to help healthcare providers (HCP) report potentially false or misleading prescription drug promotion and report it to the FDA for review. It was initiated 12 years ago and recently a quiz component was added to it. The quiz is being promoted via email to HCPs and the media to help get the word out on better monitoring of promotional pharma ads.
The Bad Ad program is run by the FDA’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER).
The new Bad Ad quiz contains ten questions about how the program works, the measures that OPDP takes and how to report dubious ads.
In 2020, the FDA received more than 135,000 prescription drug promotions for review and the number has been increasing yearly, underscoring the need for the program. It also received a record 312 reports from pharma ad watchers the same year, with its lowest being 95 reports since 2010. These numbers don’t include reports made directly to CDER and not through the program.
Moreover, the pharmaceutical industry spent more than $24 billion on drug promotion in 2017, of which $18.5 billion was spent on exclusive marketing to HCPs.
“We have done quizzes before for other topics such as hand sanitizers and sunscreens but not for the Bad Ad program. We have done outreach for the Bad Ad program through other means such as webinars, articles and continuing education,” a CDER spokesperson said in an email.
The Bad Ad program also offers courses and educational case studies.
While the program is primarily directed towards HCPs, like physicians, physician assistants, nurse practitioners, nurses and pharmacists, to raise awareness on misleading drug promotions, anyone can submit a complaint to FDA. Complaints can be anonymous but the FDA says having names and contact information is helpful in instances when the OPDP may require more information and hence needs to follow up.
The FDA also has a website for consumers to help educate them about false or misleading direct-to-consumer (DTC) promotion.
According to the program, common drug promotion issues include: overstating the drug’s benefits, not presenting balanced risk versus benefit information, excluding material facts about the drug, making unsubstantiated claims and misrepresenting data from studies, among others.
Additional strategies to help police drug promotions can be expected as the FDA and CDER continue to crack down on bad ads.
“We are always looking for new and effective ways to continue to raise awareness among healthcare providers about false or misleading prescription drug promotion while also providing them with an easy way to report it to the Agency,” CDER said.