Ahead of commercialization, companies developing drugs and medical devices communicate about their pipeline products for a variety of reasons, but most typically to attract new investors or update existing investors on developments. These communications can take many forms—company-run websites, exhibit booths at trade shows and medical meetings, and presentations at conferences—all having the greatest visibility not only to investor audiences, but also to patients, healthcare professionals, and regulators in the U.S. Beyond ensuring that investors are not misled, drug and device developers and their communications firms must carefully navigate the FDA’s prohibition on promoting investigational products while still getting their messages across regarding the potential promise that each may hold for bettering patient treatment or care.
Following are three best practices and the pitfalls to avoid:
1. While it may seem obvious, ensuring that you refer to pipeline products as “investigational” goes a long way in managing the risk of misleading investors or the FDA risk of impermissibly promoting investigational products. In a June 2018 advisory letter to a clinical-stage drug company, the FDA cited both a company website and an exhibit booth for making claims too “conclusory” as to the safety and effectiveness of the investigational drug in a promotional context. Since receiving the letter, that company revised its homepage to feature the word “investigational” prominently in the homepage’s subheading and added an asterisk and disclaimer underneath that the product “has not been approved by the FDA or any other regulatory authority for any use.” The added disclaimer may not be necessary in most scenarios, but now the investigational status is abundantly clear.
2. Balancing data and study results presented with proper context is also important. Here, proper context can include a description of the study design, total number of patients studied, p-values for endpoints, and steps remaining in the development process, each of which can help avoid the pitfalls of pre-approval communications.
3. Crystal ball gazing on what new data may mean for an investigational product is also risky. This often takes the form of company management statements about what new data “mean” for the future of the development program. Here, quotations by company management in press releases require careful review to ensure appropriate context is conveyed and that nothing too “conclusory” as to safety or efficacy is stated.
For public companies, knowing these best practices and pitfalls is doubly important. Company communications are often at the heart of securities litigation when investors feel they have been misled, so working closely with legal and regulatory advisors on pre-approval communications is just as important as the effort companies dedicate to the review of post-approval communications.