As a pharma marketer, you certainly never want to receive the dreaded FDA warning letter. It’s embarrassing, and it does not reflect well on the organization, or on your professional expertise! One way to avoid this type of damaging misstep is to pay close attention to FDA rulings regarding pharma content. For example, Hospira recently received a warning letter from the FDA’s Office of Prescription Drug Promotion over a YouTube video titled “What to Expect: Hospira Precedex.” According to the FDA, the video for the sedative Precedex did not have the appropriate fair balance, and also presented a warning and precaution, “arousability,” as a benefit in the video.
It turns out that the Precedex video was originally intended to be used on the branded Precedex website with the appropriate fair balance being displayed alongside the clip. However, eventually the video found its way to the unbranded Hospira YouTube channel, where the clip was accessible without the appropriate indications, usage, and safety information.
According to Pfizer, “The Precedex video was not intended to be viewed outside the Precedex website, which contained the important safety information. Although the video was not accessible to the public, further steps have been taken to remove the cited content from the Hospira YouTube channel as of Jan. 15, 2016,” the spokeswoman said.
While certainly not the most egregious marketing violation we have seen the FDA take issue with in recent years, this case does raise some important lessons for pharma digital marketing teams and their pharma content, especially in terms of policy, people, and process.
Policy: Make sure marketing policies and processes are documented and revisited often by marketers and agency partners. Creating MLR approved rules for engagement for each of your tactical executions is critical to avoiding mistakes that can lead to a letter from the FDA. There are a lot of new technologies that have changed the way brands engage with customers—and every angle must be reviewed and approved to ensure there is a consistent method for each new way of engaging. You must also take into consideration that people move on to new positions or jobs elsewhere, and along with them goes the policy for a tactical execution that was in their head. Don’t get lazy—documenting these policies is important!
People: You have to have experienced people who understand the ever-changing landscape of this regulated environment. That applies to marketers, but in cases like this, it magnifies how important it is to have experienced digital marketing staff and partners. Marketers need to be careful that their digital partners have demonstrated the ability to explore new frontiers, but can also apply their experience to platforms, technologies, and methods that have already been established, so they can avoid mistakes like posting a branded YouTube video without fair balance.
Process: In an era where digital content is easily copied, shared, pasted, and reposted in a myriad of channels and platforms, it may be prudent to include balance embedded directly in the particular digital artifact, regardless of what other balance might be present in the initial site. Also, checklists offer another failsafe way for ensuring that proper steps and reviews are embedded in the digital publishing process, i.e. whoever is in charge of uploading videos to the YouTube page consults a standard checklist of questions and rules before making a video live. By embedding these types of procedures into the content publishing flow, digital marketing teams can ensure that the accumulated regulatory wisdom is readily at hand, regardless of staffing changes, buyouts, change of agencies, etc.
Today’s digital platforms continue to evolve at a rapid pace, and marketing teams and their agencies must work hard to stay on the leading edge while also maintaining full compliance. Given this fast-paced environment, keeping these three “Ps” in mind—policy, people, and process—can help to ensure that an FDA warning letter does not arrive in the mail.