You Oughta Know: Companies Should Pay Attention When OPDP Drops a Warning Letter

Key Takeaways

• The Food and Drug Administration is increasing enforcement of direct-to-consumer drug promotion, with a recent Warning Letter citing misleading claims, inadequate risk disclosure, and promotion beyond approved labeling.
• Prior FDA enforcement, whether directed at your company or others, should serve as a clear compliance roadmap, and failure to incorporate those lessons increases regulatory risk.

The Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) recently issued a Warning Letter addressing direct‑to‑consumer (“DTC”) promotional communications for an approved bladder cancer therapy, focusing on a TV advertisement and a company‑produced podcast. In a nod to Alanis Morissette’s iconic “You Oughta Know,” a breakup song celebrated for calling out bad behavior, FDA calls out the company by citing previous communications to the company’s subsidiary for similar issues. The Warning Letter serves as a reminder that companies ought to know better than to disregard prior FDA feedback and enforcement, whether directed at them or at others, when planning DTC promotions.

Highlights

• DTC promotional activity at issue included a broadcast TV advertisement and a podcast episode aimed at patients. From a public health perspective, FDA viewed the target audience as a vulnerable patient population.
• FDA referenced its Bad Ad program, noting that complaints submitted through that channel contributed to the agency’s review.
• The company’s senior leadership (CEO and chief medical and technology officer) personally participated in the promotional communications.
• FDA chose to issue a Warning Letter, rather than an Untitled Letter, because the product is approved only for a specific type of bladder cancer, yet the communications suggested broader uses that FDA characterized as presenting “a significant public health concern that affects a vulnerable patient population at increased risk of medical complications and adverse outcomes.”
• The promotional materials included “cancer‑free” claims and suggested the product functioned as a vaccine, even though FDA stated it is not approved as a vaccine.
• The agency emphasized that the messaging was based on a single-arm study that could not support time-to-event endpoints such as disease-free survival. Prior OPDP letters had already warned against relying on that data set for such claims.
• By promoting uses outside the approved labeling, FDA found that the product lacked adequate directions for those uses.
• FDA objected that the materials suggested unapproved routes of administration (e.g., “single jab,” subcutaneous injection) and depicted injections inconsistent with the prescribing information (“PI”), which specifies that the product is for intravesical use only and not for subcutaneous, intravenous, or intramuscular administration.
• The agency noted that it had previously raised similar concerns in two Untitled Letters to an indirect wholly owned subsidiary regarding promotional presentations based on the same clinical program.
• FDA found that risk information was omitted or inadequately presented: the 10‑minute podcast contained no risk information, and in the TV ad, risk information appeared only after the screen went dark with a reference to a website for safety information, creating the impression that the ad had already ended.
• The agency also cited the company for failing to submit the promotional podcast on Form 2253 at the time of initial dissemination.

Observations

• DTC communications remain high risk from an OPDP enforcement standpoint. This is especially true for TV ads and similar broad‑reach media.
• While many recent OPDP letters have been Notices of Violation (“NOVs”), this action escalated to a Warning Letter, driven in large part by prior FDA comments and the identified public health risk.
• Companies should not disregard or minimize prior FDA feedback including NOVs, untitled letters, and warning letters directed to other companies in the same space. Subsequent campaigns that repeat or extend previously cited themes are likely to draw heightened scrutiny.
• Companies should treat OPDP letters to others as early warning signs, especially when companies are in the same therapeutic area or use similar study designs. Lessons learned should be incorporated into promotional review. Ignoring enforcement trends increases the risk that “novel” campaigns will be viewed as repeat violations already flagged elsewhere.
• OPDP continues to scrutinize reliance on single-arm studies for broad durability, cure, or prevention claims. Where study design limits interpretation of time-to-event endpoints, FDA is willing to characterize resulting promotions as grossly overstating benefits.
• Visuals and narratives that imply a different route of administration than the PI (e.g., depicting injections when the product is for intravesical use only) can independently drive misbranding and “new use” concerns, even if explicit wording is carefully crafted.
• Risk information must be conspicuous and prominently integrated into the core body of the messaging. Advertisers cannot structure content so that the ad appears to be over before risk information is presented.
• Company‑controlled “informal” formats such as podcasts featuring employees are still promotional communications and must fully comply with FDA’s promotional requirements.

In sum, companies should pay attention to OPDP communications like the Warning Letter. By proactively considering FDA guidance and enforcement trends, companies can minimize enforcement risk.

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