In late April, the FDA published a notice regarding the agency’s intent to study the Internet and healthcare, focusing on issues related to fair balance in advertising on the Internet. The timing and content of the announcement was, to say the least, somewhat surprising given the fact that the agency held a two-day public meeting in November 2009 for the purpose of gathering input that would inform the development of a draft guidance on medical product promotion through social media and the Internet. Subsequently the agency missed two of its deadlines and provided no insight whatsoever into the content.
In the meantime, the other means by which DDMAC is meant to provide guidance is through the issuance of regulatory action letters, however, since 2000, there has been a dramatic drop in enforcement actions. There has been a brief increase in such letters, particularly in 2009 when the agency issued 14 letters in one day – which act as an anomaly rather than an increase in activity. And ironically, those letters were about Internet advertising and fair balance. And very little insight was gleaned from those letters except to say that links to further fair balance information were insufficient, presumably because it did not meet standards for print fair balance.
The timing of the study announcement seemed ironic given the fact that everyone has been waiting for a draft guidance on the very topic. It seemed, therefore, a good time to consider the already considerable body of knowledge that has been created around the use of the Internet and social media in healthcare – particularly as greater numbers of people are engaged in their healthcare through the Internet and social media. Here are a number of studies on healthcare and the Internet from just a single source – Susannah Fox and the Pew Internet & American Life Project:
- February 2011 – Peer to Peer Healthcare – how people’s networks are expanding to include online peers, particularly in the crucible of rare disease;
- February 1, 2011 – Health Topics Survey – Survey on patient use of internet in food safety, drug safety, and pregnancy information and searches for symptoms and treatments;
- January 21, 2011 – Americans Living With Disabilities and Their Technology Profile – This report shows the discrepancy in Internet usage between American adults living with a disability and adults not listing a disability;
- December 13, 2010 – Cancer 2.0 – Focus on use of Internet for people with cancer;
- October 19, 2010 – Mobile Health 2010 – How are people using their smart phones to help manage their health;
- March 24, 2010 – Chronic Disease and the Internet – Examines how adults living with chonic disease are disproportionately offline in an online world;
- June 11, 2009 – Social Life of American Health – Insights into how the Internet and social networks sharpen the questions someone might ask when they do get to talk to a health professional.
Thanks to Pew for the great body of knowledge already generated, and for that which is yet to come.