The Consumer Brief Summary: FDA’s New Thinking Regarding Risk Communication
New FDA guidelines jettison the 'traditional approach' to fulfilling the brief summary requirement and replaces it with what the FDA calls the 'Consumer Brief Summary.' This article summarizes the new guidelines and reviews the need for additional guidelines that specifically address the fair balance section of DTC print ads.
Pharma Marketing News Vol. 14, No. 2: February 2015
Welcome to Vol. 14, Issue No. 2 (FEBRUARY 2015) of Pharma Marketing News. The FDA is a hot topic in this issue. Specifically, it's new thinking on presenting risk information in direct-to-consumer print ads. Are the new guidelines relevant for online advertising?
When It Comes to Social Media, Pharma Tells Patients: “Do As We Say, Not...
Weeding out unsavory, "offensive," or spammy comments is a fact of social media life that has to be dealt with. In general, pharmaceutical companies...
Transparency is Good in Theory, But Not in Practice
I attended SMi's Social Media in the Pharmaceutical Industry conference this week and, as usual whenever I attend these conferences in the UK, I...
FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices
"CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C...
“Innovative” Pharma Marketing Is Not Viral
Several recent articles and blog posts have claimed there is a lack of "Innovation" among pharma marketers who are afraid to "rock the boat."
World...
LAP-BAND’s Social Media Campaign Definitely Violates FDA Guidelines
I heard that a number of participants at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco were "baffled" by LAP-BAND's social media...
Are Online Peer-to-Peer Physician Discussions Overrated?
Congrats to Thibaud Guymard (@thibaudguymard), Digital Marketing Manager at MSD France, and his Comuniti team for winning the Prix Or de la Communication...
FDA’s 2015 Guidance Agenda – Just Like the 2014 Agenda – Promises Publication of...
FDA/CDER has published its 2015 Guidance Agenda (here). Here's what's under the Advertising Category:
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in...
2014 Was Another Record Year for FDA: Fewest Number of Untitled/Warning Letters Ever!
In 2014, the FDA approved 41 new drugs -- the most since 1996 (see here). That's quite a "record" even if 37% of the...
