Regulatory ad promo in a co-promotion setting

Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process for materials associated with a co-promoted product.
 
Keywords – advertising; co-promotion; promotion; medical, legal, and regulatory
 

Introduction

Pharmaceutical companies often rely on co-promotion agreements to consolidate marketing efforts and improve market penetration of a product. In such arrangements, the companies’ respective sales forces pool resources to promote a single product under the same name.¹ (That differs from co-marketing, in which companies compete in selling the same drug under different names.) A cross-functional promotional review committee (PRC) comprised of medical, legal, and regulatory (MLR) experts, also referred to as an MLR committee, is considered the gold standard forum for the review and approval of both promotional and nonpromotional, or ancillary, materials containing product information.^2,3 The overarching goal of such a committee is to maximize the commercialization of the product while minimizing risk to the company. The regulatory ad promo specialist in this forum provides guidance to the marketing team to ensure in-scope materials are accurate, truthful, not misleading, and compliant with applicable regulations, policies, and guidelines.
 
Co-promotion agreements may include a clause mandating the shared review and approval of promotional materials by both parties. This is understandable given the risks associated with any enforcement action or any investigation of marketing practices. A seemingly simple co-promotion agreement could result in an elaborate coordination of efforts between the companies to allow for a combined MLR assessment and approval of materials for the shared product. This article will address the principles, best practices, and challenges for the review of promotional materials in the co-promotion setting.
 

Standard operating procedures

It is crucial for the MLR co-promotion process to have written standard operating procedures (SOPs) in place to support the parties’ mutual commitment to compliance.⁴ An SOP for MLR provides a norm for delineating the process for review and approval. The document should include definitions of in-scope materials; the responsibilities of each function; system, review, and meeting processes; expedited reviews; an escalation process; and Form 2253 submissions. Although participant companies are likely to have their own MLR SOPs, the NDA-holder will ultimately be responsible^5,6 for fulfilling regulatory reporting requirements such as Form 2253 submissions. Therefore, best practice would be for a joint MLR committee to function in accordance with the NDA-holder’s processes to better facilitate fulfillment of the sponsor company’s obligations.
 
Business rules
To accommodate differences between the companies’ MLR processes, it may help to develop joint MLR business rules to explain and clarify specific instructions in the SOP. The business rules should be in an independent document that aligns with and complements the MLR SOP. Best practice would be for both companies to provide feedback on an initial draft of the rules before agreeing on a final version. This ensures a smooth workstream with which both parties are familiar and to which they agree.
 
A good example of using the business rule option is inclusion of an escalation process for advancing a challenge or concern up the hierarchy so that key decision makers within both companies can weigh in on a solution. A common challenge in a co-promotion relationship is that the affiliated companies may have different thresholds for compliance implications. Concerns about these differences can be addressed through a predefined escalation process that is outlined in the business rules. In defining the escalation process, the rules should address:
 

• How to proceed when the MLR committee cannot agree on an issue,
• Which decision makers will be involved in the process,
• Whether there are different processes for when reviewers and marketers cannot agree versus when marketers from the respective companies cannot agree.

 
Submitting Form 2253
Form 2253 must accompany the submission of promotional materials to the FDA. The submission must be made at the time the labeling and advertisements are released for use in accordance with the Federal Food, Drug, and Cosmetic Act and agency regulations.^5,6,7 This crucial regulatory requirement, typically coordinated by the NDA-holder, should be clearly defined and the process included in the SOP to avoid duplicative or erroneous efforts. As already noted, most companies with commercialized products already have an established SOP for promotional review. It is therefore important that all MRL members are trained in the co-promotion process as it may vary from those at their individual companies.
 

Databases and content management systems

A key operational consideration in setting up a co-promotion arrangement centers on the database or system to be used for promotional materials. As with the MLR SOP, the norm is to default to the NDA-holder’s database or system. MLR members from both companies must have access to the database/system and receive appropriate training. The training will require coordination by the NDA-holder and additional technological support. It should include information about the review process such as recording comments, requesting an additional round of review, requesting a live meeting with the full committee, and submitting Form 2253. It should also address other operational practices not familiar to non‒NDA-holder participants.
 

Adherence to internal policies and guidelines

Another challenge in the co-promotion setting is ensuring the MLR process aligns with the internal policies and guidelines of the participating companies. For example, a social media campaign for the co-promoted product should also align with the separate social media policies of the participating companies. These considerations must be addressed during the conceptualization process. This can be challenging if internal guidelines or documents cannot be shared outside of the company. As such, members of the brand team and reviewers must discuss their companies’ policies early and clearly to ensure they are aligned. The same would apply to sales training. Each company will have its own sales force and compliance policies that require separate training processes. This may need additional coordination from the brand team and double the review of training materials.
 

Teamwork, trust, and flexibility

Co-promotion entails double the number of functions in the review of materials: two reviewers each for regulatory, medical, and legal components of the process. This may lead to diverging opinions and perspectives, so it is crucial when establishing a high-functioning team that reviewers build rapport and trust, align with each other, and are flexible.⁸ Regular, high-quality, strategic feedback is integral to achieving this.
 
Mutual respect is a key element in building trust, which is best established when reviewers are united. No two regulatory reviewers will consistently provide identical opinions. In addition, their past work experience and training and their respective company cultures account for differences in reviews of materials. Scheduling routine function-focused or “regulatory-only” meetings to discuss current projects and issues may help mitigate challenges that may arise in the broader team meetings. Flexibility and adaptability are also crucial in the co-promotion setting. It is important to remember that differing opinions and ways of working are inevitable among MLR members, but that they all share a common goal of maintaining compliance while meeting business objectives.
 

Conclusion

The challenges of working within a co-promotion relationship are balanced with unique opportunities. Exposure to a partner company’s culture, staff, and ways of working provides insight and connections that a regulatory professional may not otherwise have. Establishing and maintaining productive and cordial relationships with colleagues at another company is not without effort but can be very rewarding. With an open mindset and focus on shared objectives, an effective and harmonious joint MLR environment is achievable.
 
Abbreviations
FDA, [US] Food and Drug Administration; MLR, medical, legal, regulatory; NDA, new drug application; PRC, promotional review committee; SOP, standard operating procedure.
 
About the authors
Kim Do, PharmD, is a senior manager in commercial regulatory affairs at Myovant Sciences. Before joining Myovant, she completed a postdoctoral PharmD fellowship in regulatory affairs ad promo at AbbVie in conjunction with St. John’s University, New York. Do earned a Doctor of Pharmacy degree from St. John’s University. She can be contacted at kim.do@myovant.com
 
Ursula Campbell, MS, is a senior director in global regulatory affairs at Pfizer. She has more than two decades of pharmaceutical industry experience, with a primary focus in US regulatory ad promo. Campbell has Bachelor and Master of Science degrees in pharmacy from St. John’s University, New York. She can be contacted at Ursula.Campbell@pfizer.com
 
Disclaimer The opinions and positions expressed in this article are those of the authors and are not, and should not be attributed, to their employer.
 
Citation Do K, Campbell U. Regulatory ad promo in a co-promote setting. Regulatory Focus. Published online 27 January 2023. https://www.raps.org/news-and-articles/news-articles/2023/1/regulatory-ad-promo-in-a-co-promotion-setting
 
References
All references accessed and/or verified 24 January 2023.
 

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2. Dankiewicz E. Time to review your promotional review? DIA website. Published online April 2021. https://globalforum.diaglobal.org/issue/april-2021/time-to-review-your-promotional-review/
3. International Federation of Pharmaceutical Manufacturers & Associations. Code of practice – Upholding ethical standards and sustaining trust. IFPMA website. Dated 2019. https://www.ifpma.org/wp-content/uploads/2018/09/IFPMA_Code_of_Practice_2019.pdf
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5. 21 CFR §314.81(b)(3)(i). Other reporting – Advertisements and promotional labeling. Current as of 29 November 2022. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.81
6. 21 CFR §601.12(f)(4). Advertisements and promotional labeling. Current as of 29 November 2022. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=601.12
7. Food and Drug Administration. Transmittal of advertisements and promotional labeling for drugs and biologics for human use. Federal Register. Published 21 December 2000. https://www.federalregister.gov/documents/2000/12/21/00-32617/agency-information-collection-activities-proposed-collection-comment-request-transmittal-of
8. Birt J. 14 tips for building trust at work (and why it matters). Indeed website. Updated 4 October 2022. www.indeed.com/career-advice/career-development/building-trust