AJ co-founded TrendKite in 2012 and oversees all aspects of the organization’s sales operations.
Today’s PR landscape is complex. With the number of traditional media outlets on the decline, and the number of social media and thought leadership channels on the rise, it can be difficult for any modern PR professional to keep up. Healthcare PR pros face the additional challenge of complying with regulations that the Federal Drug Administration (FDA) imposes on healthcare related communications. The intent here is not to cover the details of every government regulation, but rather, we thought it would be useful to share some of the rules, principles and definitions, specific to the FDA, that can impact your PR, advertising, and promotional efforts.
Accurate and Non-misleading Standard
FDA guidance states that the agency evaluates the “net impression” of a promotional piece “to determine whether the piece as a whole conveys an accurate and non-misleading impression of the benefits and risks of the promoted product." The FDA considers not only words or statements, but also designs and images, format, and placement and size of text. So while individual statements may be accurate and non-misleading, you must consider the impact of the piece as a whole before determining whether it meets this FDA standard.
Balanced View of Benefits and Risks
Healthcare products can provide many benefits to patients, but they often also come with risks. The FDA may determine any material as "misleading", including a press release, that does not adequately balance the benefits and risks of a healthcare product or service.
You may be thinking, “But, wait! How can I communicate the benefits and risks of my product in a 140 character Tweet?” The FDA feels your pain, but unfortunately is not moved. Recently released social media and internet guidelines state, “If the firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same tweet, then the firm should reconsider using Twitter for the intended promotional message.” They make the same statement regarding character limited advertising, such as Google Adwords. Keep in mind that linking to adequate benefit and risk information does not mitigate the company’s responsibility to address both in the initial communication.
The promotion of the off label use of prescription drugs is prohibited. That means that a drug intended and approved to fight depression, for example, cannot be promoted as a sleep aid, even if anecdotal evidence suggests that it is effective as such. Healthcare PR professionals should pay attention to the public statements of employers or clients to avoid this potential violation.
It may seem like a good idea to let third parties (who are not subject to FDA regulation) make the case for your product or service. Not so fast. In 2012 the FDA sent a warning letter to Amarc Enterprises regarding the marketing of a dietary supplement on their company Facebook page. The FDA found the company to be in violation of the accurate and non-misleading standard because the company “liked” a user’s post in which the user endorsed the product as an effective cancer treatment. Also cited was a link on the company’s timeline to a third party website regarding cancer treatment.
The FDA does not require that they approve and review all promotional materials prior to publication, however all promotional press releases, must be submitted upon initial use. The FDA states, “All advertisements and promotional labeling for a particular drug product must be submitted at the time of initial publication or dissemination.”
All of this may seem a bit overwhelming, but the bottom line is that the FDA is tasked with the important responsibility of ensuring that patients get complete, fair and reliable information about the products and services they choose. Healthcare PR professionals can partner with them by following the regulations and guidance provided by the agency. With careful thought, your PR strategy can be executed in a way that is both compliant and compelling. We highly recommend that all PR pros in the healthcare industry get further education on this subject.