Social Media Promotion in an FDA Regulated World -- Part (iv)

This is the fourth (4th) and final part to the blog series relating to social media in an FDA regulated world. This section deals with what the FDA is unlikely to want to regulate, and how to potentially tackle some of the communication problems associated with social media promotions.

Part IV

What is not likely to be regulated?

As important as knowing what is likely to be regulated, is knowing what the FDA is unlikely to want to regulate.

Source documentation that your consumers will not see:

The FDA’s core mission includes being “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” In furtherance of this mission, the FDA regulates, via divisions in CDER, CBER and CDRH, information that is distributed to consumers and healthcare providers.

However, information such as software code, including specific meta-tags that are typically unavailable to the typical consumer/ healthcare provider, will be unlikely to be targeted by the FDA, and will likely be deemed to be unworthy of its attention and enforcement.

Resultantly, while we may see additional examples of the FDA looking at meta-tags and evaluating whether specific meta-tags may be misleading, it is unlikely that the meta-tags in evaluated so far have constituted a “game changer” in that they were available and viewable to the general public.

Where does that leave us?

As we discussed, a marketing strategy that includes the internet, as it now necessarily should, will require an assessment of the internal capabilities of the company. A typical marketing and promotions meeting has always included clinicians, lawyers, regulatory folk and marketing folk from both the strategic divisions and from the print and broadcast media sections. It is important to understand and appreciate that other folks may be necessary in these meetings.

Multi-Disciplinary Team Members

There are multiple parties involved in meetings relating to promotional compliance. These parties, as previously suggested, may include lawyers, clinicians, regulatory and marketing individuals. These individuals or teams each have their own jargon and communicate in ways that are unlikely to be understood by other individuals at such meetings. This jargon, and varied understanding, heightens the risk of miscommunication between the parties. This risk of miscommunication often maximizes the chances of problems occurring, and in the event of an actual problem may result in finger pointing and blame shifting. It is hence important that multidisciplinary individuals who can communicate across multiple subject matters be at the table to “translate” for other team members. Typically, such individuals must necessarily have not only an understanding of the clinical discussion but at least one if not more other factors that must be considered by other members at the meeting. This ability to translate for other members will allow for team building and rapport generation and provide the teams the ability to work through any possible mis-communications, resulting in decreased violative content being allowed to “pass through” such promotional meetings.