Several key details must be kept in mind to ensure regulatory compliance while creating promotional materials for prescription drugs. The content should be accurate and provide full and balanced disclosure of material facts and related risks, if any. The claims made in the promotional material should be explicitly included in the FDA-approved indication. Also, the product claims should be supported by substantial evidence.
The FDA has chalked out what it considers a balanced and substantiated claim that falls within product indications over the years. The Office of Prescription Drug Promotion (OPDP) points out key violations observed in promotional claims by the FDA. These include:
• Failing to present the material facts and risks involved in promotional material: The FDA requires a balanced presentation of risks and benefits while promoting prescription drugs. Through OPDP, it has issued several letters that censure pharmaceutical companies for their failure to include risk information and other important facts in promotional information. The disclosure of risk information goes beyond merely providing a statement of risks—these risks need to be fairly presented along with the benefits. FDA emphasizes on the net impression conveyed by all the elements of the piece. Prescription drugs should carry information regarding usage, dosage, and limitations of use.
• Inconsistency with usage and indications in product label: The claims about the prescription drug should be in line with FDA-approved product labeling. Any deviation from the labeling can lead to charges of promoting off-label uses. Every aspect of the promotional material, including headlines, text, patient and product depiction, should conform to label indications. Misstating approved indications and usage of the product can lead to serious consequences.
• Inability to substantiate claims: Even now, OPDP keeps finding product claims that are false or misleading. Promotional materials are considered misleading when they contain drug comparisons suggesting that the drug is safer or more effective, without substantial evidence or clinical experience to support the claim. Failing to provide substantive information to support promotional claims is a common mistake that has often been the cause of violation in letters issued by OPDP regarding prescription drugs since 2015.
In brief, it is essential to verify the truth of promotional content and ensure that it is not misleading. The content should provide a full and balanced disclosure of material facts and risks involved. Any product claims should be approved by the FDA and supported by substantial evidence. Adhering to these guidelines aid in avoiding common promotional mistakes made by companies and unwelcome attention from OPDP regarding prescription drugs.
CIO Review Client: Flagship