With anticipated launches of novel therapies and increasing sales for currently marketed prescription products, life sciences companies will be reviewing several thousands of materials in the New Year for distribution through multiple, diverse channels. Processes are available to optimize MLR at the global level, including content factories (hubs), enabling companies to centrally control content while making assets available quickly, and efficiently across global organizations for marketers and promotional agencies.
Content hubs streamline production and cut costs. However, what happens when local affiliates regionalize content from hubs and translate copy to address local language, nuance, and regulatory compliance requirements? Just because global content is approved and ready for use doesn’t necessarily mean users will create compliant promotion.
Well-oiled global review must differentiate between how materials are managed (“process”) from how content is optimized (“quality of content input/output”). These are inter-related contributors to efficiency and marketing effectiveness, requiring discrete solutions. Content input/output quality can be optimized when companies:
- Foster development of submission-ready content by originators.
- Precheck materials to reduce editorial burden on reviewers.
- Audit content after materials have been released into market for quality improvement.
- Fuel high-performing, cross-functional teams that trust one another.
“For a competitive edge, companies need trained staff and enabling software to generate differentiating content with claim substantiation and create compelling, compliant promotion from globally approved factory content,” asserts Preeti Pinto, formerly Executive Director, Head of Promotional Regulatory Affairs, AstraZeneca and Founder, Preeti Pinto and Associates.
Diagnostic Questions for Submission-Ready Content
Observation: Few companies have enterprise-wide training that puts all employees on the same regulatory knowledge baseline. Ask yourself:
- Do we have standardized training for content originators to ensure understanding of fundamental government requirements for promotion?
- How are new members without brand history brought up to speed quickly?
- Are we certifying that content originators understand the basic regulations? If not, how do we know whether they can apply the requirements? How do we identify and close knowledge gaps to reduce vulnerability?
According to Rina Newton, Managing Director, CompliMed, “The U.K. ABPI Code of Practice includes strict requirements for certification of promotional and some non-promotional items. In addition, the PMCPA’s Guidance on Certification states certification is often the final step in a process that involves review by a range of staff prior to final approval.”
“Our clients need to feel secure that we are taking appropriate measures to protect them and their brands,” explains Carolyn Morgan, President of precisioneffect. “As part of a highly regulated, fast-pace, growing business, we set a high bar for employees when it comes to quality and knowledge, which is why we invest in compliance education for every new team member that walks through our door.”
Prechecks for Cleaner Materials
Observation: Few companies capitalize on the upstream opportunity to eliminate non-negotiables from content before materials are reviewed. Current checklists, when utilized, are paper-based.
- How often do materials need to be reworked due to non-negotiable non-compliant elements? Brand/style editorial errors? Repeated errors?
- How do specific promotional types influence reworks?
- Do commercial teams understand how reviewers think? Do reviewers understand emerging regulations (e.g., digital guidances)?
- Is everyone clear on “no go” claims so teams can focus on development of alternate claims?
- Where does consistency across pieces breakdown?
Reduced Editorial Burden on Marketing Operations and Reviewers
Observation: The cost of copyediting errors has not been benchmarked.
- What percentage of time do reviewers spend on editing versus reviewing?
- How does time lost to editing affect time to review materials in the queue or partner with marketing on strategy?
- Do we utilize methodologies that speed identification of errors without increasing stakeholder burden?
“Software that automates pre-checks free up reviewers to focus on strategy versus mundane items,” notes Pinto.
Auditing Content After Materials are Released
Observation: Review processes must be continually refined based on learnings from audits of materials deemed approvable based on then-current regulations and corporate compliance decisions. Software can increase audit efficiencies.
- Is content accurate and consistent across all media channels?
- Do new regulations render approved pieces non-compliant for future use?
- Have audit findings been categorized/prioritized into corrective and preventative actions and communicated to embed learning points?
- Do we bring requirements to life with training sessions about warning letters?
- Can we make dashboards and audit reports more actionable by categorizing them according to regulatory knowledge gaps, editorial errors, and red flag phrases?
“Checklists serve as auditable standards to allow anyone (not just compliance) to retrospectively monitor compliance with regulatory requirements,” says Newton. “Moreover, checklists can be tailored to include internal requirements and decisions.”
High Performing Cross-Functional Teams that Trust One Another
Observation: Organizational silos lead to duplication and misunderstandings. Business partnering skills for promotional review are needed.
- Do we view MLR review as a business enabler or sales suppressor?
- Do team members walk into review meetings ready to do battle or to actively listen and be solution-focused?
- Are we boosting productivity through knowledge sharing and open communication? Are we creating a fertile environment for original thinking and out-of-the-box suggestions?
- Do concept meetings allow for early discussion between stakeholders to communicate concerns and suggest/justify alternative actions?
“Being an impactful business leader requires a blend of subject matter awareness and the ability to rally a team around a vision or critical goal,” explains Jessica Pfennig, Compliance Business Partner – North America Commercial Operations and Oncology Business Unit, AstraZeneca Pharmaceuticals. Pfennig is a certified business partner in digital innovation, having completed the first-ever certificate program to address trust-building among cross-functional teams in life sciences.
“By improving individual and team performance, our program helps boost productivity through greater sharing and leveraging of resources; eliminates time wasted on discussions about non-negotiable, non-compliant programs/materials; and enables companies and careers to achieve exceptional outcomes,” adds Liz Coyle, EVP, Value Offerings, Healthcare Businesswomen’s Association (HBA), which offers the certificate program with CCC.
Every company wants to nurture smooth, agile MLR processes for global content and review of promotional materials at the affiliate level. Here’s to a New Year in which functional partners unite to reduce unnecessary cycles and ensure that the correct skill sets are in place to manage risk.