Pipeline products are the lifeblood not only of established device companies but also of startup companies, as their future success hinges on their ability to successfully move products out of the development stage and into commercial distribution and market acceptance. While the U.S. Food and Drug Administration (FDA) prohibits the commercialization of investigational medical devices in the premarket stage, companies can communicate about their pipeline products in a number of ways that do not run afoul of the FDA and that help advance corporate business objectives. If companies stray from the types of communications the FDA allows, they run the risk of enforcement action and even government investigations and litigation, which could be not only be costly, but could also be disruptive to their businesses. To help effectively manage this risk, several best practices companies can be employed in their communications.
When is Promotion and Test Marketing Prohibited?
The FDA prohibits the promotion or test marketing of investigational devices until after the FDA issues an approval or premarket clearance (510(k)) for those devices. More broadly, the FDA also restricts companies from representing premarket devices as safe or effective for the uses for which they remain under investigation. Failing to heed these restrictions can result in the FDA publicly issuing the device company an enforcement letter, whether an untitled letter or a warning letter, that identifies all of the marketing or promotional claims the company has made that constitute prohibited premarket promotion.
Receiving such a letter places a company on the FDA’s radar, sheds a negative public light on the company’s reputation and often requires demonstration to the FDA that the company has learned its lesson and will not engage in premarket promotion in the future. Beyond the FDA, there are potential liabilities under the healthcare fraud and abuse laws, such as False Claims Act violations related to the promotion of investigational uses for marketed products, that can lead to significant penalties and government settlements.
For companies looking to secure investment in their new technologies or to identify development partners to help bring their technologies to market, the perceived inability to talk about those technologies as a result of the FDA’s restrictions can make the road to commercial distribution and market acceptance seem daunting—if not impossible—to navigate. However, the FDA does allow certain corporate premarket communications that it typically will not regard as prohibited premarket promotion.
1. Scientific exchange is the first among these. While the FDA discusses scientific exchange in its drug regulations, it is widely understood to apply in the device arena as well. The FDA provides that it will not regard communications involving the “full exchange of scientific information” about the premarket product, including the dissemination of scientific findings in scientific or lay media, as promotional. Press releases reporting the latest scientific findings for emerging technologies or scientific presentations about those technologies at medical congresses, for example, are not generally considered promotional.
2. The FDA generally does not restrict premarket discussions of existing medical needs and diseases that aim toward raising awareness of signs and symptoms or encouraging consumers to talk to their doctors. For example, device developers are permitted to discuss medical conditions and diseases that are the focus of their development efforts so long as those communications do not focus on the company’s specific device. Similarly, device companies can communicate about their corporate missions and their general commitments to developing products for particular disease spaces.
3. Device companies can discuss their product pipelines so long as they do not promote or represent the uses for those products as having already been proven safe or effective. Similar to scientific exchange, the FDA will not restrict the truthful and non-misleading presentation of information about a pipeline product (its technology platform, technological features, uses under investigation, steps remaining to FDA clearance or approval, etc.) as long as the investigational nature of the device is clear and the net impression of the communication does not represent the device as safe or effective for its investigational use. Here, for example, companies can develop a pipeline section of their websites with an overview of their proprietary technology, its technological features and uses under investigation.
In addition, the FDA provides in one of its device Compliance Policy Guides that companies may advertise or display a device that is the subject of a pending 510(k) premarket notification submission but cannot take orders or prepare to do so. Here, you might see a device company launch a branded product website with a prominent 510(k)-pending disclaimer or advertise its 510(k)-pending device in an exhibit hall booth, but booth personnel do not track attendees interested in the device.
Best Practices to Minimize Risk
Finally, while the above examples reflect some of the types of communications the FDA would permit in the premarket stage for a device, a company can quickly find itself in risky waters if the content of those communications is not carefully prepared and reviewed with an eye toward the FDA’s prohibitions. Following are some best practices companies can employ to minimize their risk of engaging in impermissible premarket promotion.
- Ensure that all premarket communications are truthful and non-misleading, balanced by risk information and include contextual disclosures for any data or findings presented (e.g., labeling data as “preliminary” if final data are not available).
- Ensure scientific or medical personnel, rather than sales or marketing personnel, lead company communications regarding premarket devices.
- Ensure premarket communications identify pipeline products as investigational and present the steps remaining to clearance or approval.
- Ensure premarket communications do not interpret study findings or make conclusive statements about product safety or efficacy.
- Ensure the look and feel and overall impression of premarket communications is not promotional.
While these can be tricky regulatory waters to navigate, with the exercise of caution in the development of premarket communications, device companies have several available avenues for permissible corporate communications about their pipeline products. Employing these best practices and bearing in mind the FDA’s prohibitions, device developers will be well on their way to avoiding enforcement actions in the premarket stage.