The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2. I was able to attend sporadically and participated on a panel the second day on Social Media and Medical Product Companies.
The conference had strong attendance, with several pharmaceutical companies present as well as those of us who work with them. FDA was represented in force and the agenda patterned that of previous years, starting out with updates regarding enforcement from each CBER, CDER, CDRH and CVM. The one from CDER provided a few case studies from enforcement since last year, covered the name change from DDMAC to the Office of Prescription Drug Promotion (OPDP) and though listing the development of guidances as one of the top priorities, specifics were short in supply and overall the presentation was looking back and not forward.
In a presentation offering Updates on Guidances, FDA offered a thorough review of the draft guidance on responding to unsolicited requests for off-label information about drugs and devices. It was a good presentation and anyone seeking information about that guidance should review the deck. For those of us waiting for an update on the draft guidances related to social media which are now years behind schedule, we apparently have longer to wait.
The panel that covered Trend in Enforcement that included a presentation from the numbers of cases involving pharmaceutical manufacturers and medical device manufacturers and a continued focus on individual accountability within organizations.
My panel was on social media and we were asked to provide hypothetical social media situations that presented questions for discussion. The problem is, of course, that with FDA’s inability to provide timely guidance in any form on the topic, almost any discussion of any social media activity involves more questions than answers. The hypothetical that I devised dealt with a pharmaceutical company that made a new HIV drug that was the subject of a blog posting by a well-known AIDS Activist whereby he discussed the positive impact that the HIV treatment had on his Hepatitis C. He was widely read by media and patients alike and he posted links to the blog posting on the corporate Facebook page of the company – which were then taken down. The resulting controversy resulted in a great deal of publicity over the potential off label use. It was meant to characterize the current state of the environment where the lack of guidance may actually be a catalyst to cause the spread of misinformation.
Many other important subjects were discussed during the two days. If you are intersted, there are links to all of the presentations here and in fact, FDLI has a link on this page which will allow you to download all of the presentations into a single file. The hashtag for the conference was #FDLIAP if you are interested in seeing tweets sent during the two days.