Not Ready for Prime Time: FDA Issues a Notice of Violation for Promotion of an Investigational New Drug

Key Takeaways

• The Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Notice of Violation (“NOV”) to a prescription drug company for promoting its investigational new drug at a major medical conference.
• The NOV found that the exhibit booth display and brochure made conclusory safety and efficacy claims about an investigational drug, containing a Schedule III controlled substance active ingredient, that had only been studied in Phase 1 clinical trials.
• The agency emphasized that the exhibit booth failed to include any information indicating that it was an investigational new drug, and its proximity to booths for approved products compounded the misleading impression.

For those of us old enough to remember the early years of Saturday Night Live, we recall that the first cast was referred to as the “Not Ready for Prime Time Players.” In the FDA world, we might refer to investigational new drug products as not ready for prime time, as the agency has not approved them for safety or efficacy. In a recently issued NOV, FDA’s OPDP reinforced this point.

Why FDA Found the Investigational Drug Promotion Misleading

• OPDP said that the exhibit booth display and brochure represented, “in a promotional context,” that the investigational product was safe and effective for its proposed indication.
• The claims were particularly concerning because the active ingredient of the investigational product was a Schedule III controlled substance associated with serious risks.
• Many of the claims were conclusory, such as “[the investigational product] Breaks Key Barriers. . .,” “No abuse signals,” and “No overall sedative, dissociative, psychosis-like side effects.”
• The investigational product had only been studied in Phase 1 clinical trials, making the promotional safety and efficacy claims especially concerning given the limited data available.
• The exhibit booth display and brochure represented that the investigational product was superior to approved drug products in the treatment class, specifically by suggesting it did not have certain side effects associated with similar products (despite the absence of comparative data).
• The exhibit booth display did not include any information indicating that the product was an investigational new drug, not approved by FDA.
• The product’s booth appeared in the conference exhibit hall near booths for approved products, further contributing to the impression that the drug was commercially available

What FDA’s Notice of Violation Means for Drug Companies

• As we constantly remind clients, OPDP officials attend major medical conferences, particularly those focused on specific therapeutic areas. To use a driving analogy, companies should always drive safely and comply with the law. However, they should be especially alert when the police are in the neighborhood. Similarly, drug companies should always be on their best behavior when attending and displaying at medical conferences and should exercise heightened diligence when OPDP officials are likely to attend.
• As noted, an investigational new drug is not ready for prime time. It is not approved. To use a baseball analogy, the drug is still in the minor leagues, while an approved product is in the majors. Approved products may not be perfect, but they have passed FDA’s safety and efficacy review and obtained approval. Comparisons between an investigational drug and approved products, unless in a protocol, that suggest superiority in some form are misleading and can imply approval status. Here, claims about the absence of side effects based solely on Phase 1 data, compared against an approved drug class, represented a clear error.
• The failure to disclose that the product was an investigational new drug appears to be an unforced error. Although the company may have believed the investigational status was apparent from context, a clear and prominent notation of the drug’s status would have substantially minimized risk.
• The NOV specifically highlighted the proximity of the exhibit booth to booths for approved, commercially available products, which contributed to the overall impression that the investigational product was approved. We appreciate that venue layouts may not always permit separate areas for commercial and investigational booths. However, when booths are co-located in the same exhibit hall without separation, it becomes even more imperative that any booth for an investigational new drug be clearly marked as such. Any individual approaching a booth, whether an FDA official, a physician, or a competitor, should be able to determine quickly whether the information presented at a booth relates to an investigational or an approved product.
• While OPDP can issue an NOV or Warning Letter for any type of prescription drug, the agency specifically noted in this letter that the active ingredient was a Schedule III controlled substance. This underscores the heightened regulatory sensitivity surrounding investigational products with known abuse potential and serious safety risks.
• We have written extensively about the recent wave of OPDP enforcement letters targeting direct-to-consumer promotion. This NOV is a reminder that OPDP’s scrutiny also covers healthcare professional-focused settings, including medical conferences.
• If a drug company participates in a medical conference and has an exhibit booth with materials for an investigational product, it must carefully review all language, signage, and materials to ensure compliance with applicable regulations. If you want to be a prime-time player, prepare like one.

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