Marketing Collateral and promotional material, such as Visual Aids and Leave Behind Literature (LBLs) have been used by pharmaceutical firms for a long time. But with the advent of digital media and Pharma 4.0, we have seen a rise in the combination of physical and digital communication and digital promotion by pharmaceutical firms. DTC (Direct-to-consumer) Pharmaceutical advertising has also seen a large growth, especially in the U.S., where even prescription drug advertising is regulated but not barred.

The primary objective of any promotional material guided towards the public, or a part of it, is to communicate the benefits as well as the shortcomings (if any) of the medicinal product effectively and clearly. Advertising in the pharma industry should be done without obfuscating Regulatory constraints and following the pharmaceutical advertising regulations as mandated by the Regulatory authorities.

In the U.S., the Federal Food, Drug, and Cosmetic Act (FDCA) and Title 21 of the Code of Federal Regulations Part 202 (21 CFR Part 202) are the two major Pharmaceutical Advertising Regulations that govern prescription drug advertising and promotion. Together, both regulations - the FDCA and the 21 CFR Part 202 - govern how the pharma companies should promote prescription drugs to both healthcare professionals and consumers.

In addition to these regulations, the FDA issued guidance documents and OPDP Regulatory Information provide current thinking on several topics related to prescription drugs & OTC drugs promotion/advertising to Health Care Professionals and DTC (Direct-to-consumer) advertising.

If it finds materials to be violating the laws and mandates thus put into place, the Office of Prescription Drug Promotion (OPDP) issues two letters - an NOV and a Warning letter.

  • an Untitled Letter or Notice of Violation (NOV), which is essentially a cease-and-desist letter
  • a Warning Letter where the offender is required to do corrective advertising, which is expensive and time-consuming

Both types of letters identify various violations that OPDP has found in the promotional materials, which often include false or misleading risk presentation, false or misleading benefit presentation, and lack of adequate directions for use. 

This is why, at Freyr, we perform a thorough check on promotional and non-promotional material, to help our clients ensure compliance across every media channel.

Review points considered while a medical review of the ad promo pieces include, but are not limited to:

  • Check if the scientific interpretation of the content is appropriate and carries the data correctly from the source documents such as journal articles, prescribing information to ad promo materials
  • Making sure not to have overwhelming language for the product’s efficacy and safety
  • Facts have been presented, and it is the same as the approved labeling document
  • Claims related data for accuracy

Review points considered while a Regulatory review of the ad promo pieces include, but are not limited to:

  • Consistency in the information between source documents and ad promo pieces on the content perspective
  • Looking for appropriate words or phrases to be used or not to be used based on the relevance of the product-specific details (e.g., drug of choice, FDA Approved, etc.)
  • Formatting and grammatical check
  • Holistic review to confirm the information presented is readable and understandable by the end-user based on the audience in scope

While the content of the promotional material is largely the deciding factor in avoiding OPDP enforcement letters, their submission format and adherence to guidelines also play a large role in getting approvals. More often than not, something as simple as referring to the  OPDP eCTD Form 2253 checklist can help ensure that your promotional material OPDP eCTD submissions are done the right way.

To ensure compliance with the OPDP regulatory information and FDA regulations on advertising and promotional materials, having an experienced partner to review these promotional materials, find possible discrepancies and suggest corrective remediation strategies while also responding to FDA queries, if they arise - is often profitable for any pharmaceutical firm.


Freyr supports a Regulatory and Medical review of

  • Indication Claim Documents  
  • CME Material  
  • Patient Support Applications
  • Important Safety Information  
  • Pharmaceutical Press Releases  
  • Conference Handouts  
  • Patient Brochures and Bulletins
  • Learning Modules  
  • Core Visual Aids  
  • Product Information for Websites (Webpages)  
  • Advertorials/Banners for Websites  
  • Extensions of Campaign/Marketing Material  
  • Ads in the Printed Press (Magazines, Newspapers, Periodical Publications, etc.)  
  • Presentations of spokespersons or MedReps (Speaker Decks)  
  • Sales Training Documents 

Freyr also has expertise in

  • FDA Query support and Response 
  • DDMAC /OPDP submission package creation 
  • 21 CFR Part 11 compliance and compliant e-signature 
  • FDA 2253 Submission error resolution 
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