It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals. In the US, a significant amount is also spent on direct advertising to consumers. In a report by the FDA on Keeping Drug Advertising Honest and Balanced, Thomas Abrams, director of the Office of Prescription Drug Promotion (OPDP), shares on how the agency “protects consumers from false and misleading ads for prescription drugs that appear on TV, radio, online and in print publications.”
In the US and New Zealand, direct-to-consumer advertising is allowed because of the First Amendment, which provides for freedom of speech, including commercial speech by pharmaceutical companies. Abrams however points out that the FDA has been charged by law to ensure accurate and balanced advertising so that consumers are provided with helpful information about the medical conditions and the drugs to treat them.
According to Abrams, drug companies are required to submit to the OPDP their advertisements and other promotional materials at the time they make them public. “We receive anywhere from 6,000 – 8,000 pieces of advertising and promotional submissions each month. The materials are assigned to one of our 32 reviewers, who specialize in specific drug categories, such as asthma medicines or cardiac treatments. Many reviewers are healthcare professionals with diverse backgrounds in academia, industry, hospitals and pharmacies. They use a risk-based approach that allows them to prioritize their work to quickly identify promotional materials with the most potential for negative impact on public health,” says Abrams.
In cases of misleading or false promotion (e.g., an advertisement claiming that a product is more effective or safer than has been demonstrated), the OPDP will issue enforcement letters to the company and legal actions can be taken through the Justice Department if such form advertising is not discontinued. “We also pay careful attention to balance, making sure the risks are displayed prominently so that they can be read, heard and understood easily,” Abrams adds.
When asked if social media has complicated the job, Abrams says it has due to the increased volume of materials and speed of delivery afforded by the Internet. He gave an example where the OPDP had in the past acted against a company that developed and posted a video testimonial featuring a well-known TV celebrity promoting its drug on YouTube. A warning letter was issued, noting the promotional testimonial violated the regulations by overstating the benefits of the products without mentioning its risks.
“The area of prescription drug promotion is such a dynamic one,” says Abrams in his concluding remarks. “The number of vehicles and ways that companies promote their products has increased significantly, as well as the amount of promotion. The office at FDA has had to grow with it.”
For those who are unaware, the FDA has a Bad Ad program, administered by the OPDP and designed to educate healthcare providers about the role they can play in helping to ensure that prescription drug advertising and promotion is truthful and not misleading. A video on “What to do about misleading drug ads” by the FDA is available in Medscape’s website.