Most life sciences companies are aware of the dangers of marketing noncompliance on their products.
In recent years, major pharmaceutical organizations have been ordered to pay fines of $1.5-2.2 billion to the US Department of Justice for off-label promotion of products which constituted fraud in the eyes of the US FDA. Hiding the risks of a drug or promoting outcomes without scientific evidence can be an extremely costly mistake.
Falling out of compliance is also remarkably easy--your organization can be found noncompliant with regulatory guidance for many reasons, including national marketing campaigns or even a misleading sales presentation.
While most life sciences companies are aware of these risks, many aren't sure of the best way to create checks and balances around marketing materials. A robust QA process is necessary to ensure your company doesn't fall out of compliance with promotions, but how do you create this process? With some effective planning and the right tools, you can sleep more soundly at night, knowing that your marketing materials are valid and within regulatory bounds.
We'll show you a few steps you can take to enable quality controls on your life sciences marketing materials.
Enabling Quality Controls on Life Sciences Marketing Materials
The FDA's strict guidance on medical product communications is a tool to ensure patient safety. "Marketing activities and communications regarding the safety and effectiveness of a medical product...that are not properly supported by scientific evidence may create a false or misleading impression...which can lead to prescribing or use decisions that harm patients."
While there's no shortage of examples of off-label promotions that present no significant risk to safety, there are countless other examples of off-label marketing that lead to frightening patient outcomes.
In one recent case study, a major pharmaceutical brand’s drug was approved for treating anemia caused by renal failure and chemotherapy-induced anemia, but not anemia caused by cancer. The pharmaceutical brand ended up paying more than $750 million to resolve False Claims Act allegations after pharmaceutical sales representatives promoted the drug as a treatment for cancer-caused anemia to physicians.
Effective marketing for life sciences requires strict control over communications to ensure truthfulness and avoid costly regulatory action. Strict controls are needed, but not at the cost of velocity. Your processes and technology must support fast approvals so your marketing campaigns can launch quickly and help you gain a competitive advantage.
Your QA processes should be built on explicit knowledge of regulations, involve a well-defined workflow, and incorporate the right technologies for document and asset management.
Understand the Boundaries
The FDA has a long list of regulations for compliant life science marketing, including its strict enforcement of off-label promotion. In summary, life sciences organizations must have explicit approval to market anything with a "therapeutic claim." Before anything can be sold to treat or prevent a disease, the life sciences organization must submit data to substantiate the claim. Also, the organization must have all systems in place under 210 and 211 current good manufacturing practices (cGMP).
If your marketing materials claim to treat, prevent, or mitigate a disease, the product becomes subject to FDA oversight. There's plenty of examples of organizations who make unsubstantiated claims for herbal products and are quickly shut down by the FDA.
Life sciences organizations need to be very, very careful to market within the boundaries of their approved labeling and avoid off-label promotion. According to Former FDA Commissioner Robert Califf, the agency is careful to regulate information that could harm patients. "Communications that are not based on sound science, or otherwise mislead audiences about the benefits or risks of the product, or about the strength of the evidence can inappropriately influence prescribing use or decisions in a way that harms patients."
Despite the controversy surrounding the FDA's off-labeling rules, the agency remains firm in their stance about off-label promotions and protecting patient safety. It's critical to know the precise boundaries as they relate to promoting your drug, biologic product, or medical device.
In January 2017, the FDA released draft guidance and a memo on truthful marketing. The guidance noted that evidence does not support effective outcomes from unapproved drug uses, and off-label drug use can increase the risk of adverse patient events, especially when the unapproved use does not include strong scientific evidence.
Some of the marketing guidance from the FDA includes, but is not limited to:
- Data for efficacy must meet established evidentiary thresholds for review and approval.
- Organizations must avoid fraud by clearly presenting evidence and benefit/risk profiles.
- Required labeling must be accurate and informative to patients.
- Promotional materials must be “reliable” and created with “integrity.”
- Life sciences organizations must ensure marketing produces “informed consent.”
The Right eQMS Can Help Ensure Compliance
An electronic quality management system (eQMS) with robust document management features can easily handle marketing material approvals. Marketing materials for digital and print promotions are just a document, which may take the form of PDFs, image files, video files, or other content.
An eQMS with approval workflows can gather the appropriate teams and stakeholders for a standardized workflow, which reduces the risks of non-compliant marketing. The document control team can ensure that all available materials are easily accessible and provide tools to remove outdated materials from distribution.
The right eQMS can also support compliant sales and marketing in the field. A cloud-based QMS can make electronic versions of data sheets and video content available to field staff on desktops and mobile devices. It can also automate distribution to a global workforce by allowing marketing to assign access to the right stakeholders at the right time.
An eQMS which offers strong version control and search functions is crucial to avoid issues related to non-complaint marketing or outdated marketing which can damage your brand reputation. Problems can occur when a sales team member pulls an outdated presentation because the current version was difficult to find, and the document control team had lost track of the older version. Ensure your eQMS system provides tools for organizing documents via tagging and tools for periodic review of your assets.
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Map Out the Approval Process
Compliant marketing in the life sciences industry is a collaborative effort. Marketing produces assets, and the assets are routed through medical, legal, and regulatory (MLR) teams for approval before the content can be taken live. At global life sciences organizations, the approval workflow can be particularly complex due to the unique compliance requirements which exist in different international markets.
Trying to manage approvals manually can be an enormous productivity risk and a risk to quality and compliance. Using emails or a file-sharing solution can result in late approvals, missing approvals, or difficulty compiling feedback from internal stakeholders. The first step to streamlining approvals for quality, compliance, and efficiency is to map the process. Create a workflow of all of the individuals in the organization who must review and sign-off on a marketing asset before it can be released.
When you’ve created a workflow, build this process into your eQMS software to create automation. The right software can enable global collaboration by allowing marketing to automatically assign stakeholders to the document and send automated reminders for timely review.
Establish A Marketing Materials Library
Digital asset management is key to compliant marketing in the life sciences industry. Your QMS should support the creation of a marketing materials library to enable marketing, sales, and other individuals to access approved materials on-demand.
At global enterprises or SMB with complex asset management needs, this may be achieved by the use of a dynamic digital asset management library (DAM) solution such as CampaignDrive by Pica9 for secure and centralized asset sharing. At other organizations with limited global distribution, the marketing materials library can be adequately managed inside the eQMS software.
Considerations that should shape your approach to a marketing materials library include:
- User permissions
- Workflow capabilities
- Support for multiple asset types
- Localization capabilities
- Project management capabilities
- Reporting and analytics
Quality Controls Matter in Life Sciences Marketing
The average life sciences organization dedicates 20-30 percent of their total budget to marketing. If your organization is found guilty of fraudulent marketing activity due to off-label promotion, your marketing budget could immediately become extremely bloated due to regulatory fines.
Due to the risks of noncompliance and fierce marketing competition in many industry verticals, a robust quality assurance process is a necessity.
Controls for your marketing process should be an extension of your greater quality management system. Quality, compliant marketing materials are another way your organization can work towards your goals of selling quality products for better patient outcomes. Trying to manage complicated workflow approvals manually can inhibit productivity or lead to compliance risks.
With the right technologies for quality management and digital asset management, you can build automated workflows within boundaries and provide an updated, compliant asset library for your marketing and sales teams.