Although the FDA does not pre-approve promotional materials for prescription drugs, it does monitor these materials to ensure they adhere to the FDA regulations. When disseminating new promotional materials, pharmaceutical companies are required to submit a copy of these materials to the FDA using Form FDA 2253.1 After reviewing this form, the FDA may find that certain materials violate some aspects of FDA regulations. Additionally, consumers and health care professionals can report potentially false or misleading promotion of a prescription drug directly to the FDA. Promotional materials that are deemed to be misleading and false can results in a Warning Letter or Untitled Letter.
What is the Most Common Violation in Promotional Materials?
I reviewed Warning and Untitled Letters issued by the FDA from 2015 to 2020 and published on the FDA website.2 I found that the most common type of violations in promotional materials of a prescription drug involves missing or inadequate risk information. A total of 29 out of 48 Warning and Untitled Letters involved omission of risk information and 10 involved risk minimizations.
Most of the materials that omitted risk information were intended for health care professionals, while the majority of materials that minimized risk were primarily intended for patients. The majority of materials with risk omission resulted in a Warning Letter, while the majority of materials that minimized risks resulted in an Untitled Letter.
How to Avoid the Most Common Violation in Promotional Materials
One main action we can take to avoid getting the FDA’s Warning Letter for risk omission is to make sure the complete risk information is included in a promotional material. This risk information should include Contraindications, Warnings and Precautions, Adverse Reactions, and boxed warning if any.
The FDA also has specific requirements on how to present risk information on different formats of promotional material. Here are a few tips for each format to make sure your promotional materials adhere to the FDA regulations:
- Place risk information at the same location as the benefit information. For example, risk information should be on each page of a brochure. For a booth panel, risk information should be placed on the same panel that contains benefit claims.
- Use the same structure and similar font size for risk and benefit information. If you have headings and subheads for your benefit claims, you should have headings and subheads for your risk information. Font size for risk information should not be much smaller than font size used for benefit claims.
Broadcast ad
- Verbalize risk information using the same voiceover and the same pace as benefit information. Super only is not enough.
- Make sure visuals shown during risk information verbalization do not distract consumers from properly listening to the risk (e.g., face-changing visuals).
- If you also show the risk information as a super, make sure no competing super shown at the same frame.
Social media ad/post
- Include the complete risk information whenever you have benefit claims. Link to the Prescribing Information without the full risk information is not enough.
Email campaign
- Place risk information before the email’s signature block and follow the same rule on structure and font size as that for print materials.
You can find more detailed information on how to present risk information in promotional materials on the Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion.3 Remember to always follow the “fair balance” rule when creating promotional materials for a prescription drug.4
References:
- US Food and Drug Administration. Providing regulatory submissions in electronic and non-electronic format – Promotional labeling and advertising materials for human prescription drugs: Guidance for industry. June 2019. Accessed February 21, 2021. https://www.fda.gov/media/128163/download
- Warning letters and notice of violation letters to pharmaceutical companies. US Food and Drug Administration. Updated February 9, 2021. Accessed February 21, 2021. https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies
- US Food and Drug Administration. Guidance for industry: Presenting risk information in prescription drug and medical device promotion. May 2009. Accessed February 21, 2021. https://www.fda.gov/media/76269/download
- Drug advertising: A glossary of terms. US Food and Drug Administration. Updated January 19, 2020. Accessed February 21, 2021. https://www.fda.gov/drugs/prescription-drug-advertising/drug-advertising-glossary-terms#F
