FDA guidance around packaging and labeling for software associated with prescription drugs

Software and digital tools continue to advance the pharmaceutical space, designed to help patients use prescription drugs safely and effectively. Some software applications consist of data-entry functions where patients input their data manually. Other applications are digitally connected to a drug or device, collecting patient data automatically. Both methods can provide valuable insights and useful information for improving patient care.

This most recent guidance discusses how drug sponsors can describe their software in FDA-required labeling and promotional labeling. If the drug sponsor submits evidence demonstrating that the use of prescription drug use-related software leads to a clinically meaningful benefit, the end-user output associated with the software function generally would constitute FDA-required labeling. “FDA-required labeling is reviewed and approved by the agency and includes the Prescribing Information (PI), a resource for prescribers that contains a summary of the essential scientific information needed for safe and effective drug use.”

When the drug sponsor does not submit evidence of a clinically meaningful benefit, the end-user output would be considered promotional labeling. “Promotional labeling is generally any labeling other than FDA-required labeling and is intended to promote or advertise the drug. Sponsors must submit promotional labeling to CDER at the time the labeling is initially disseminated.”

The benefits of digital health tools for patients

Digital health supports a variety of patient and prescriber benefits across the healthcare spectrum. Some benefits hoped to be achieved through digital health initiatives include:

• Engagement & Adherence – patients that take a greater part in managing their health experience better results from both medication adherence and lifestyle management.

• Monitoring & Diagnosis – many digital health initiatives support increased patient data outside of visits to the clinic to get better insight for clearer action plans.

• Management & Intervention – many future technologies use ongoing disease management to prompt intervening actions or even prevent negative events through predictive modeling.

• Access & Awareness – as our world becomes more connected through technology, digital health can help support health education and consistent access to appropriate treatment.

This is a quickly-evolving space with innovation developing across healthcare, pharmaceutical, technology, and consumer industries. Digital health is likely to become the new “traditional.”

Tips for branding your digital health portfolio

Brand development is a key consideration in commercialization when thinking about the future of digital health and the evolution of what is currently the traditional approach to medication. Some key questions to ask when pursuing an appropriate brand strategy for a digital health portfolio include:

• What is the pipeline for the portfolio?
  In addition to the offerings available at launch, how could the portfolio evolve? This could include pharmaceutical products, devices or routes of administration, as well as digital solutions or analytics tools.

• How might offerings in the portfolio interact?
  Some offerings may be experienced as product agnostic, others may be closely connected or work exclusively together. These offering interactions can greatly impact brand relationships to facilitate appropriate usage.

• What are our business goals and route(s) to market?
  Often business goals are not the same for each offering in a portfolio. Brand strategy working alongside business strategy helps support brand development decisions and investment.

• What regulatory guidances and legal requirements impact decision making?
  In an evolving space, understanding the landscape is important to protect intellectual property, reduce risk of infringement and support alignment with global regulatory agencies.

Brand architecture strategy defines the roles and relationships of brands in a portfolio. A defined brand architecture strategy and system for future decision making is critical to building a strong and clear portfolio to support brand success.

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