Disclosures: Gray and Kalola report no relevant financial disclosures.
September 13, 2021
2 min read
Save

FDA: Prescribers can help stop false or misleading prescription drug promotion

Disclosures: Gray and Kalola report no relevant financial disclosures.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

It is estimated that the pharmaceutical industry spent more than $24 billion on prescription drug promotion in 2017.

Prescription drug promotion can provide prescribers with information about the latest drug therapies and may be part of their decision-making when treating patients. It is particularly important because it may inform prescribers’ assessments of the risks and benefits of a drug. The FDA needs your assistance in helping to ensure that this information is truthful and not misleading. Availability of such information contributes to quality patient care.

An infographic that provides examples of false or misleading prescription drug promotion, such as omitting or downplaying of risk and overstating the drug’s benefits.

Challenges in monitoring prescription drug promotion

For most prescription drug products, drug companies are required to submit their promotional materials to the FDA when the materials first appear in public. This means the FDA sees many promotional materials at about the same time as the public.

Prescription drug promotion is everywhere. In 2020 alone, the FDA’s Office of Prescription Drug Promotion (OPDP) received over 135,000 unique pieces of prescription drug promotional materials. Prescription drug promotion not only includes written and printed materials such as journal advertisements and sales aids, but it also includes industry-sponsored speaker programs, social media, detailing from sales representatives and booths in exhibit halls at conferences. Monitoring it is essential, but the FDA can be challenged by the vast amount of promotion and potentially limited access to promotion in some of these settings. Given these challenges, the FDA is seeking your assistance to help us ensure that prescription drug promotion is truthful and not misleading.

FDA’s Bad Ad Program

When prescribers encounter prescription drug promotion that appears to be false or misleading, they can report it to the OPDP’s Bad Ad Program. As of January 2021, the FDA received more 2,100 reports, and in cases where the promotion met the criteria needed for further agency action, OPDP moved forward with a risk-based compliance strategy to put a stop to the promotion.

Common issues identified in false or misleading prescription drug promotion include:

  • omitting or downplaying of risk;
  • overstating the drug’s benefits;
  • failing to present a “fair balance” of risk and benefit information;
  • omitting material facts about the drug;
  • making claims that are not appropriately supported;
  • misrepresenting data from studies;
  • making misleading drug comparisons; and
  • promoting an investigational drug as safe and effective for the use(s) under investigation when the drug has not been proven to be safe and effective within the meaning of the Federal Food, Drug, and Cosmetic Act.

Remember, any prescription drug promotion that is potentially false or misleading is reportable to the Bad Ad Program, and even in cases where the reports may not lead to a compliance action, these reports still serve as valuable information to focus OPDP’s ongoing surveillance activities.

FDA offers CE course and case studies

As part of the Bad Ad Program, the FDA is offering a continuing education (CE) course and has developed case studies based on real-life examples. The CE course provides a self-paced training, while the case studies, designed to be used in a teaching setting, are based on actual compliance letters issued by the FDA to companies regarding alleged false or misleading prescription drug promotion. The CE course and case studies can be accessed here.

How to report to Bad Ad

Report potentially false or misleading prescription drug promotion to the FDA by sending an e-mail to BadAd@fda.gov or calling 855-RX-BADAD (855-792-2323).

Reports can be submitted anonymously; however, the FDA encourages you to include contact information so that we can follow up, if necessary, to obtain additional information.

Your input goes a long way toward helping ensure that prescription drug promotion is truthful, balanced and accurately communicated.