Prescription Drug Ad Compliance Advertising Checklist

This checklist serves as a guide for [Your Company Name] to ensure all prescription drug advertisements comply with regulatory standards. Follow each step carefully to maintain legal and ethical integrity in your advertising practices.

1. Legal and Regulatory Compliance

• Confirm adherence to all FDA guidelines regarding content, fair balance, and presentation in the advertisement.

• Ensure compliance with both state and federal laws, including any specific regional advertising restrictions.

• Check that the ad does not promote off-label use of the drug, which is prohibited under FDA regulations.

• If the ad includes comparative claims with other drugs, verify they are supported by scientific evidence and presented fairly.

• Consider consulting with regulatory experts or legal counsel to validate compliance, especially for complex or high-profile campaigns.

2. Accuracy and Non-Misleading Content

• All statements must be supported by clinical studies or approved drug labeling.

• Information should be easily understandable by the general public, avoiding medical jargon where possible.

• Ensure that any quantifiable claims are clearly supported by data, with any limitations or study contexts adequately disclosed.

• Maintain records of the data or studies that substantiate the claims made in the ad.

• Present risk information in a manner that is easily noticeable and understandable by consumers.

• Avoid overstating the effectiveness or safety of the drug.

3. Balanced Presentation of Risks and Benefits

• Both positive and negative aspects of the drug should be presented with equal prominence.

• Ensure that the most serious and frequent risks are prominently displayed.

• Present risks within the context of the drug's benefits, helping consumers make informed decisions.

• Avoid presentation formats or techniques that minimize the visibility or impact of risk information.

• Ensure that risk information is consistent with the drug’s FDA-approved labeling.

• If patient testimonials are used, ensure they do not misrepresent or downplay the risks.

4. Appropriateness of Language and Imagery

• Language should be appropriate for a medical product and should not include colloquialisms or slang.

• Visuals should accurately represent the drug’s intended use and should not be overly dramatic or emotionally manipulative.

• Be culturally sensitive and avoid stereotypes or generalizations in language and imagery.

• Ensure that the language used is understandable to the average consumer without medical training.

• If endorsements are used, ensure they are from credible and qualified medical professionals.

• Do not use fear or intimidation as a tactic to promote the drug.

5. Disclosure Requirements

• Disclosures must include the drug’s generic name, approved uses, and any significant risks or side effects.

• The sponsoring pharmaceutical company should be clearly identified.

• Disclosures should be presented in a manner that ensures a fair balance between benefit and risk information.

• All disclosures must be clear and conspicuous, easily readable or understandable by the average viewer.

• If the ad directs consumers to a website, ensure the website also complies with regulatory standards.

• Regularly update disclosures to reflect any new safety information or FDA warnings.

6. Target Audience and Distribution Channels

• Ensure the advertisement is suitable for the demographics of the audience, especially in terms of health and age.

• Choose channels that are appropriate and do not target an underage or inappropriate audience.

• Be mindful of geographic-specific regulations and cultural sensitivities.

• Select media channels wisely, considering the nature and sensitivity of the drug being advertised.

• Ensure that the ad is suitable for the level of understanding of the intended audience.

• Be aware of and comply with any restrictions on certain types of media (e.g., television, radio).

7. Review and Approval Process

• Conduct a thorough internal review to ensure compliance before the ad is released.

• Maintain detailed records of the review process, approvals, and any modifications made.

• Have the ad reviewed by legal and regulatory experts, especially for complex drug products.

• Establish a clear process for revising and re-evaluating advertisements based on feedback or updated regulations.

• Keep documentation organized and readily available for regulatory audits or inquiries.

• Regularly train marketing and compliance teams on the latest advertising regulations and best practices.

Prepared by:

[Your Name]

[Your Job Title]

[Your Company Name]

[Your Email]

Date: [Date]

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