Marketing Collateral, such as Visual Aids or 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 a combination of physical and digital communication and digital promotion by pharmaceutical firms.
The primary objective of any promotional material guided towards the public, or a part of it, is to effectively and clearly communicate the benefits as well as the shortcomings (if any) of the medicinal product. This should be without obfuscating Regulatory constraints and the following Pharmaceutical Advertising Regulations.
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 to provide their current thinking on several topics related to prescription drug promotion and pharma 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 the 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. More often than not, something as simple as this OPDP eCTD Form 2253 checklist, helps ensure compliance.
To avoid getting into the bad books of the OPDP or any other Federal Body, having an experienced partner to review these promotional materials, find possible discrepancies and suggest corrective remediation strategies is often profitable for the 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