(My FDA, Just Wrote Me) A Letter: OPDP Delivers Two New Untitled Letters for Misleading Promotional Communications

Key Takeaways

• The Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) continues active enforcement through the issuance of Untitled Letters across multiple promotional channels, addressing both healthcare professional (“HCP”)-directed emails and direct-to-consumer (“DTC”) video content in its two most recent letters.
• Both letters underscore core compliance risks: creating a misleading net impression of a product’s approved indication (broadening the scope of indicated use) and misrepresenting conditions of use by oversimplifying FDA-approved Instructions for Use and administration requirements in promotional materials.
• Life sciences companies should carefully review promotional materials to ensure that indication statements track the full specificity of approved labeling and that any references to product use or administration accurately reflect the FDA-approved Instructions for Use; qualifying language or partial disclosures elsewhere in the piece will not cure a misleading front-end message.
• Companies should apply the net impression doctrine holistically, evaluating the overall takeaway of the communication, rather than relying on statements that may be truthful in isolation but misleading in context, as OPDP calls out singular issues in each of these two most recent letters.

FDA OPDP Issues Two Untitled Letters Targeting HCP Emails and DTC Patient Testimonial Video

The Box Tops’ 1967 hit “The Letter,” sung by Alex Chilton, came to mind as we reviewed two recent Untitled Letters from OPDP. Much like the song’s narrator eagerly reading his baby’s letter, life sciences companies have much to digest with OPDP correspondence these days; the agency continues to steadily deliver enforcement letters.

OPDP recently issued two Untitled Letters addressing distinct promotional channels and audiences: (1) HCP emails; and (2) a DTC patient testimonial video. While the two letters target different media and therapeutic categories, they share common enforcement themes consistent with OPDP’s recent pattern of scrutiny.

OPDP Finds HCP Emails Misleadingly Broadened the FDA-Approved Indication

• OPDP reviewed two professional emails submitted under Form FDA 2253 and determined that the emails were false or misleading, thereby misbranding the company’s biologic in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).
• OPDP identified the following violative claims in the promotional emails:
  • “HELP PREVENT RSV DISEASE IN INFANTS WITH BEYFORTUS® AND SEE HOW YOU CAN AFFECT POPULATION HEALTH”
  • “[I]mmunizing infants to help protect against the risk of RSV disease remains important through the entirety of the RSV season”
  • “[The product] is a monoclonal antibody that helps prevent RSV disease starting from Day 1 after injection”
  • “Your efforts in immunizing infants against RSV disease can impact the population health burden in your community”
• OPDP determined that these claims created a misleading impression that the product was indicated for the general prevention of RSV (including both upper and lower respiratory tract disease), when the FDA-approved indication is limited to “the prevention of Respiratory Syncytial Virus (“RSV”) lower respiratory tract disease.” By repeatedly referencing “RSV disease,” without the critical qualifier “lower respiratory tract,” the emails broadened, in OPDP’s opinion, the scope of the product’s approved indication.
• The agency acknowledged that the full approved indication was presented further down in the emails. However, the agency found this insufficient to correct the overall misleading impression created by the prominent claims. Technically accurate qualifying language, when presented after a misleading front-end message, does not fix the misleading impression.
• The Untitled Letter did not contain any additional complaints regarding product claims, only calling out one area of violative claims.

OPDP Finds Patient Testimonial Video Misrepresented Product Administration

• OPDP reviewed a DTC video submitted under Form FDA 2253 and determined that the video is false or misleading, thereby misbranding the product.
• The video featured two patients who made the following statements:
  • “The one thing I love about the [product] is when I am running late, I can do it on the way to school in the car.”
  • “My favorite things about the [product] are how portable it is, how quick it is to use, and how you can use it anywhere… We have used it on vacation, in the car, and while running out of the door on the way to school.”
• These statements created the misleading impression that patients can administer the product “anywhere” — including in a car or while rushing out the door — without concern for proper administration conditions. However, the FDA-approved Instructions for Use (“IFU”) require specific conditions for safe and effective use, comprising 23 total steps.
• OPDP noted that actions resulting in incomplete emptying of capsules, or storage and handling conditions, exposing the device or capsules to moisture, may reduce the delivered drug amount and result in a suboptimal dose.
• While the video included some use-related information, OPDP found this insufficient to mitigate the overall misleading impression that patients do not need to follow the IFU carefully.
• Similar to the other Untitled Letter, this one did not contain any additional complaints regarding product claims, only violative claims regarding product administration.

What the Untitled Letters Mean for Life Sciences Companies

• The net impression doctrine remains OPDP’s primary analytical framework. Both letters reinforce that OPDP evaluates the overall takeaway of each promotional communication, not merely individual statements in isolation. Qualifying language or technically accurate disclosures placed later in a piece will not cure a misleading impression created by prominent front-end messaging. Promotional review committees (e.g., MLR/PRC) should focus on what a reasonable viewer or reader can take away from the most prominent claims before reaching any qualifying language.
• Indication statements must track the full specificity of approved labeling. Omissions, such as failing to include the full disease name, can broaden the indicated use. Companies should ensure that every promotional piece provides the complete indication prominently so as not to mislead consumers.
• IFUs and administration conditions are FDA-approved content that must not be oversimplified. Promotional content, including patient testimonials, must not convey a use experience that is inconsistent with the conditions specified in the FDA-approved IFU (e.g., easy to use). Testimonials and patient stories are powerful promotional tools, but they must be reviewed to ensure they do not imply that a product can be used under conditions not contemplated by (or inconsistent with) the IFU. Patients may speak to their individual experience, but their testimony must still be compliant with promotional standards and reflect a typical patient experience.
• OPDP’s enforcement broadly covers promotional mediums and intended audiences. These two letters, issued within days of each other, targeted professional emails and a DTC patient testimonial video. Companies should not assume that any particular medium is beyond OPDP’s scrutiny. All channels, including digital, social media, video testimonials, and HCP email campaigns, should receive rigorous internal promotional review.
• Patient testimonials require the same level of regulatory review as company-authored copy. OPDP holds companies responsible for the content of patient and caregiver statements in promotional videos. Companies should ensure that patient testimonials do not convey experiences inconsistent with the product’s labeling or typical patient use, including conditions of administration.
• Both of these letters contain singular violations. While Untitled Letters and Warning Letters typically address a list of violations, these letters each focus on one specific violation per letter. So, where companies previously took some solace in believing that OPDP only came after companies that had materials with several violative claims, this is no longer the case. Companies should be careful and consider specific claims or themes that may have pushed the regulatory limits.

A company does not want OPDP writing a letter about its “baby” (i.e., drug product). The agency continues to deliver enforcement correspondence with purpose and consistency. These two letters remind industry that OPDP is watching across channels, therapeutic areas, and product types.

For guidance on these issues, please contact a member of AGG’s Food & Drug team.