A New Compliance Mechanism for Life Sciences

Remaining innovative and effective when developing products that satisfy unmet patient needs is imperative to the well-being of the population and the healthcare system overall. However, this is met with many challenges as life sciences organizations are faced with an increasing number of regulatory requirements which span across multiple geographies, departments, and business activities.

With this complex nature of new product portfolios and associated compliance requirements, a perfect storm has been created for many leadership teams within the industry—including Marketing and Sales.

How can technology help promote compliant sales materials? >>

Compliance for Marketing and Sales

Brand compliance within a life sciences organization is something that keeps many Marketing leaders up at night. While it’s a cornerstone for this department—and the fabric of both brand reputation and demand generation—brand compliance is as much a part of the Sales organization too.

With that being said, a Sales team shouldn’t be tasked with policing brand compliance.

Sales reps are the ones out in the field building a brand with powerful, face-to-face interactions. To be truly patient-centric, sales reps needs to know their materials and brand messaging inside and out to communicate details with complete accuracy to healthcare providers (HCPs) and buying groups within a very limited timeframe.

If the brand is misrepresented, there’s suddenly friction between customer expectation and customer experience, in addition to the compliance aspect of miscommunicated messages. This is where implementing a compliance mechanism as part of a digital transformation is crucial.

The Cost of Non-Compliant Promotion

When it comes to promoting a product within the life sciences industry, any piece of collateral that makes a claim can be under the surveillance of the FDA. With numerous product lines, countless indications, and multiple regions around the globe, companies inevitably make oversights. Some of these oversights include:

  • Omitting material facts
  • Misbranding a product
  • Making unsubstantiated claims
  • Not including the most up-to-date data

Noncompliant activities are no joking matter in this industry as they typically bring a hefty price tag and reputational damage. However, not every case of improper marketing results in a multi-million-dollar settlement or is due to intentional misbranding. Often, the FDA issues warning letters for smaller-scale missteps.

But regardless of intention, each slip-up can misinform a healthcare professional and/or the patient. Therefore, identifying, analyzing, and mitigating compliance risks are essential in developing an effective program and ensuring the future sustainability of the industry.

A Single Source of Truth

Sales enablement facilitates a compliance mechanism by providing Marketing with a single source of truth. By allowing Marketing to organize, store, and distribute collateral in and from a centralized repository, they’re given ultimate version control and can ensure that sellers aren’t using old, outdated documents that could put a life sciences company and patient lives at risk.

With sales enablement as part of an organization’s digital transformation:

  • Marketing will be able to sleep better knowing compliant materials and messages are being utilized at all times; and
  • Sales can be confident engaging in more meaningful conversations without the associated risk.

This process requires cross-functional collaboration, which not only helps increase company-wide alignment, but at the end of the day, focuses on a new level of engagement and helps improve patient outcomes.