Recognizing and Reporting Potentially False or Misleading Prescription Drug Promotion with Dr. Catherine Gray
Q&A with FDA Podcast | Transcript
Dr. Roach: Welcome to “Q&A with FDA.” In this podcast series, we aim to answer some of the most frequently asked questions that we’ve received from the public. My name is Dr. Sara Roach, and today we are discussing FDA's Bad Ad Program, designed to help healthcare professionals recognize and report potentially false or misleading prescription drug promotion. Here in our Division, we are often contacted by concerned healthcare professionals that have come across an ad they would like to report to FDA.
Today we are joined by Dr. Catherine Gray, director of the Office of Prescription Drug Promotion, or OPDP, in FDA’s Center for Drug Evaluation and Research. Dr. Gray, thank you for joining us today.
Dr. Gray: Thanks for having me!
Dr. Roach: As healthcare professionals, we have all been exposed to some form of prescription drug promotional communication, whether it’s in the form of a television or radio advertisement or prescription drug promotion on social media or in print. And we also receive questions and concerns from consumers who are exposed to direct-to-consumer prescription drug advertising. Can you start us off today by explaining the FDA's Office of Prescription Drug Promotion’s or better known as OPDP’s, role in regulating prescription drug promotion?
Dr. Gray: Sure. So both prescription and non-prescription drugs are often promoted, but the distinction to draw before we go any further for the listening audience is that OPDP regulates solely prescription drug promotional communications that are made by or on behalf of the drug’s manufacturer, packer, or distributor. In 1962, Congress passed a law that amended the Federal Food, Drug, and Cosmetic Act that gave FDA authority over prescription drug advertising. However, certain other kinds of medical product promotion, such as promotion for non-prescription (or over-the-counter) drugs, drugs for animals, or medical devices is regulated by other parts of the FDA or agencies outside of the FDA, such as the Federal Trade Commission. For simplicity in this conversation, I’ll refer to those materials regulated by OPDP as “promotion.”
Dr. Roach: Can you break down for our audience what that means? Maybe start with what OPDP is looking for when monitoring prescription drug promotion?
Dr. Gray: Sure. We monitor prescription drug promotion, regardless of the platform, medium, or form, to ensure compliance with applicable legal requirements. We’re looking for several things. At the most basic level prescription drug promotion must be truthful and non-misleading. This generally means that promotional communications and the information contained within them must be truthful, balanced, and accurately communicated.
Promotion that includes a drug’s name with the claim about the drug’s benefits must also present the most important risks associated with the drug and not omit facts, such as facts about the consequences that may result from the use of the drug for the purpose of which it is being promoted.
FDA takes its responsibilities seriously, particularly when it comes to the monitoring and identification of false or misleading prescription drug promotional communications. However, given the sheer number of prescription drug promotional communications that enter the public domain each year, it can pose challenges.
Dr. Roach: Is that why you launched the Bad Ad program?
Dr. Gray: Actually, yes. Our traditional regulatory authorities primarily rely on reviewing promotional materials submitted by pharmaceutical companies; investigating complaints; and conducting risk-based field surveillance. Though these activities are effective, we aren’t able to monitor drug promotion in other settings such as communications about prescription drugs that take place in physician offices, local dinner programs, direct texting from pharmaceutical representatives, or speaker presentations.
We established the Bad Ad Program to raise awareness of the most common regulatory issues in prescription drug promotion and to serve as a way in which healthcare professionals can report suspected false or misleading prescription drug promotion to FDA.
This way, FDA, in collaboration with concerned healthcare professionals, can help to ensure that prescription drug promotion is truthful and not misleading, when and wherever it may occur. And it’s pretty simple. To report, healthcare professionals can call us at 855-RX-BADAD or 855-792-2323, or send us an email at BadAd@fda.gov.
Dr. Roach: I think it’s important to note that although the Bad Ad Program itself is targeted primarily towards healthcare professionals, anyone can submit a complaint to FDA, even about direct-to-consumer promotion.
Dr. Gray: That’s a good point. But in comparing the budgeted dollars for the two audience categories – healthcare professional and direct-to-consumer promotion - spending by pharmaceutical companies to market prescription drugs directly to healthcare professionals outpaces direct-to-consumer promotion by more than 3 to 1. That disparity in promotion highlights why reporting by health care professionals is so important.
Dr. Roach: What types of prescription drug promotion do you want healthcare professionals to be considering when they are thinking about the Bad Ad program?
Dr. Gray: We want healthcare professionals thinking about all the interactions they have with promotional communications when they think about reporting to the Bad Ad Program. Pharmaceutical companies reach out to healthcare professionals through a variety of means, such as through TV and radio advertisements, one-on-one interactions between sales representatives and healthcare professionals, speaker programs where a paid speaker or key opinion leader is presenting on behalf of a pharmaceutical company, internet-based promotion, social media, and many different kinds of written or printed materials.
Dr. Roach: Can you describe some of the common issues that are reported to the Bad Ad Program?
Dr. Gray: Sure. Some common complaints are for prescription drug promotional materials that omit or downplay the risks of a medication or overstate the drug’s benefits. The promotional communication may fail to present a “fair balance” of risk and benefit information or omit material facts about the drug.
Other common prescription drug promotion complaints concern materials making claims that are not appropriately supported, misrepresenting data from studies, making misleading drug comparisons, or promoting an investigational drug as safe and effective when the drug has not been proven as safe and effective.
Dr. Roach: Do you have any specific examples to share?
Dr. Gray: Yes. Our interest is often piqued when an advertisement appears to misleadingly represent data from studies by stating, for example, “100% effective.” Or if it states that it’s a “cure all” – these claims may be false or misleading if they cannot be supported.
Or if a sales representative states, “Drug X delivers results in as little as 3 days” and you learn later that clinical trials examined results at 12 weeks and there is no available data or evidence to support earlier results. These situations may be overstating the efficacy of a drug.
A promotional representation about a prescription drug that describes a drug’s benefits but does not mention its risks is an example of a promotional communication that omits the risks of a product and creates a misleading representation or suggestion regarding the drug’s safety.
Another example is an ad that makes comparisons between two drugs and concludes that one drug is superior to the other when there isn’t support demonstrating such a difference.
Healthcare professionals should always reference the FDA approved labeling for the drug being promoted as a starting point to evaluate the information conveyed in the promotion.
Dr. Roach: Your Office, OPDP, has developed several resources to help healthcare professionals recognize potentially false or misleading prescription drug promotion. For example, the online course “The Bad Ad Program and Prescription Drug Promotion,” which includes real-life case studies, is very helpful to those wanting to learn more. Can you share more about the Bad Ad Program resources?
Dr. Gray: Absolutely. FDA has a dedicated website, fda.gov/Badad, designed to help educate healthcare professionals on how to recognize potentially false or misleading prescription drug promotion. The audience can find the course you mentioned under the link for “Bad Ad Course and Educational Case Studies.” You’ll also find other webinars, frequently asked questions, and additional resources on the webpage.
We also seek out opportunities to work with healthcare professional organizations to provide members with information regarding the Bad Ad Program and prescription drug promotion through webinars. OPDP folks can even provide in-service training for large medical groups and hospitals.
OPDP also exhibits at several major medical conferences throughout the year to help educate healthcare professionals about the program and how to recognize and report potentially false or misleading prescription drug promotion.
Dr. Roach: Can you summarize what happens after a healthcare professional submits a BadAd complaint? What can they expect to have happen after that?
Dr. Gray: That’s a great question. Once a complaint is submitted, it is carefully reviewed by OPDP. This process takes time because we must be very thorough in our investigation. OPDP will acknowledge every complaint about prescription drug promotion. If we have any follow up questions, we may reach out for additional information or clarification.
If after the investigation is complete, OPDP believes that the promotional communication violates the Food, Drug, and Cosmetic Act and implementing regulations, OPDP will take appropriate steps to notify the manufacturer, packer, or distributor of our concerns and then request that they address the violative promotion. We pursue a path toward voluntary compliance on the part of the manufacturer, packer, or distributor of the prescription drug. This usually takes the form of sending the manufacturer, packer, or distributor an Untitled or Warning Letter which provides notice to companies of our concerns about the violations and then requesting that they discontinue use of the violative promotion or that they discontinue marketing the drug. And in the case of a Warning Letter, we request that companies conduct corrective communications to help correct the false or misleading representations and suggestions contained within the promotion.
In some cases, we may also refer the promotion for criminal investigation or enforcement through FDA’s Office of Criminal Investigations or the Department of Justice. And in other cases where the Bad Ad reports may not result in compliance, the complaint or report and the resulting investigation may still serve as valuable information in focusing OPDP’s ongoing surveillance activities.
Dr. Roach: And how often do you receive complaints?
Dr. Gray: As of October of 2024, the Bad Ad program has received more than 3,200 reports of potentially false or misleading promotion. And in several cases, OPDP has been able to stop the false or misleading promotion.
Our Untitled and Warning Letters are posted online, so we encourage you to visit FDA’s website if you’re interested in seeing them. We usually will acknowledge receiving a complaint through the Bad Ad program in our Untitled and Warning Letters, if applicable.
Dr. Roach: It’s great to hear about all the important work your office is doing to protect public health, and the impact that each of these reports can have on stopping false or misleading prescription drug promotion. Do you have any final thoughts or takeaways to share with our audience today?
Dr. Gray: I’d like to emphasize to healthcare professionals how important their Bad Ad reports are. By reporting suspected false or misleading prescription drug promotion, healthcare professionals can help ensure that the information they’re relying on is truthful and not misleading. Their reports also contribute to the protection of patients and the public health.
Dr. Roach: Thank you again Dr. Gray for providing your insights on FDA’s Bad Ad program. Again, to report suspected false or misleading prescription drug promotion, healthcare professionals can call us at 855-RX-BADAD or 855-792-2323 or send us an email at BadAd@fda.gov.
Thanks for listening to “Q&A with FDA”. The full podcast and transcript of this recording is available at fda.gov/qawithfda. Many of our episodes offer continuing education credits for healthcare professionals, so be sure to visit fda.gov/qawithfda for more details.
If you are looking for additional learning or continuing education credit opportunities, including live and home study webinars, you’ll also want to check out fda.gov/CDERLearn and fda.gov/DDIWebinars.
If you have questions about this episode, or anything drug-related, email us at druginfo@fda.hhs.gov.
Sources:
- The Bad Ad Program
- The Bad Ad Program Infographic: Report False or Misleading Prescription Drug Promotion
- FDA’s ‘Bad Ad’ Program Encourages HCPs to Report False or Misleading Prescription Drug Promotion
- The FDA Bad Ad Program and Prescription Drug Promotion
- The FDA Bad Ad Program: A Conversation with FDA’s Office of Prescription Drug Promotion
- Prescription Drug Advertising | Questions and Answers | FDA