Despite the Internet being around for quite some time, the FDA has never issued specific guidance to pharmaceutical companies on how they can communicate about and market their products online, instead stating that the existing guidelines for print and television should be applied. However, there is difficulty in interpretation: if providing the prescribing information on the back of a print ad is acceptable, is that equal to having the information one click away? Instead of official guidance and directives, we learn what is okay – and what doesn’t fly – through the warning letters that are issued to companies. I always compare this to walking through an obstacle course blindfolded. When you hit a wall (get a warning letter), you learn not to go that way.
Social media has created even more gray area and more potential for warning letters, as we saw with the recent letter Novartis received. This HDCU covers some recent news about the FDA and those much-anticipated guidelines.
Last November
As a reminder, it was last November that the FDA held a public hearing for companies, advocacy groups and individuals to weigh in and provide their suggestions to the agency on what the guidelines should entail. Many ideas were put forth, including ways to present risk information in a shortened format. The FDA also accepted written testimony through February of this year; however, the ultimate decision is in their hands.
Crack Down
Despite an overwhelming case load, the Division of Drug Marketing, Advertising and Communication (DDMAC) at the FDA has been busy this year: they’ve already issued 45 warnings through August 28, compared to 41 letters for all of 2009 and only 28 for 2008.
On the Record
In a recent interview with Reuters, Thomas Abrams, who leads DDMAC, said the agency aims to release a draft later this year. “We are developing separate guidance that are issue-specific and can apply to the various mediums used on the Internet,” he told Reuters.
Mobile App Gets Approval
In early August, the FDA granted clearance to the health software firm WellDoc to begin marketing its DiabetesManager System, a mobile phone application designed to help patients and health care providers manage Type 2 diabetes. It will be interesting to see if this sets a precedence – should all health-related apps be approved by the FDA?
In the Interim
Given the current environment, it may be tempting for pharma companies to hold off on any new initiatives, especially social media, until the official guidance is delivered. However, there is a serious risk in NOT being involved: it opens the door for someone else to define your brand. We are counseling our clients on how to get involved in social media, following the existing guidelines and applying them to this medium in a responsible way.
