Innovating Without Misrepresenting: Promoting Products Through a CFL Lens
Lisa Hubbard and Sissi Pham
In 2018, the Food and Drug Administration issued the final guidance titled “Medical Product Communications that are Consistent with the FDA-required labeling” (herein referred to as CFL). According to the FDA, the guidance was responsive to medical product firms’ interest in including in their promotional materials, “data and information about the approved/cleared uses of their products that are not contained in their products’ FDA-required labeling.” FDA also indicated that the guidance sought to “provide clarity regarding FDA’s thinking when examining the consistency of a firm’s product communications with that product’s own FDA-required labeling.” Since 2018, medical product firms and FDA have strived to execute the compliant communication of this valuable information.
Over the last five years, medical product firms have carefully developed strategies, policies, and procedures regarding the use of CFL-communications that provide advantages for medical products in a variety of settings. For example, CFL data may provide healthcare professionals (HCPs) and consumers with refined information regarding how an approved product works, targeted information regarding special populations, clarifying information adverse reactions, or unique features regarding data generated during clinical trials.
CFL compliant data may also provide valuable information to payers, although CFL and healthcare economic information (HCEI) evidentiary standards differ.
Recent compliance letters issued by FDA’s Office of Prescription Drug Promotion as well as language in the background section of the CFL guidance, provide insight regarding the value the FDA places on ensuring that medical product communications for all audiences ⚠️ are not generally false or misleading despite the presence of what appears to be CFL data. CFL product communications should be compliant based on the three-factor analysis outlined in the body of the CFL guidance:
Labeled conditions for use
Increased potential for harm
Available labeled instructions for use
However, the background section of the guidance also reminds industry that, “Product communications that are consistent with a product’s FDA-required labeling but are false or misleading may subject a firm to enforcement action under the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
As the CFL guidance matures and medical product firms and FDA continue working to produce compliant product communications, teams should repeatedly consider the question, “Is the message false or misleading even though the data passes the CFL three-factor analysis?”
Key future considerations
Based on FDA’s compliance letters, consider applying additional scrutiny to concise derivative materials that may include the use of CFL-data. HCEI, social media, and broadcast advertisements may require additional scrutiny of disclaimers, claims, and overall messaging in order to avoid misleading presentations and noncompliance.
In summary, the CFL guidance has added value to product communications for medical product firms. The guidance and recent FDA compliance actions shed light on how FDA makes decisions regarding compliant CFL presentations. Striking the balance between compliance and innovation can be challenging but it is possible. Evaluation of the elements of CFL under the umbrella of the FD&C Act and the regulations related to medical product communications is beneficial throughout the life cycle of promotional communication development and particular beneficial as shorter derivative communications are developed over time.
Contact us if you would like our help to brainstorm, share pitfalls and best practices to developing internal ways of working to fully leverage the CFL guidance.