FDLI Conference – Part 2 – Janet Woodcock Speech

At the opening of the 20th Food and Drug Law Institute Conference Annual Advertising and Promotion Conference, CDER's Dr. Janet Woodcock stood in for Dr. Margaret Hamburg who was said to have had a scheduling conflict due to a meeting with HHS Secretary Sebelius.  

Woodcock Official photo JW2

Dr. Woodcock began by saying that advertising promotion, while always a central issue, is going to be even more so in the months to come and stressed the importance  of the need to achieve a balance in the communications from medical product manufacturers to patients.  There was nothing new there. What was new, is that she stated that there were two drivers of change in the environment – the increasing complexity of products and the enormous changes in the way people communication in general, with social media mentioned specifically.  As a result, she said that the FDA is taking specific steps to meet the challenges of the changing environment.

First, however, she reiterated two priorities for the agency.  First is the overarching priority to fulfill the agency's mission to protect the public health and this specifically pointed to a lack of compliance in the communications that companies may undertake with patients.  In the same breath, she mentioned that the FDA has lost credibility with the public and that credibility was essential for the agency.  The implication here was that the FDA is going to go out of its way to ensure enforcement in a very public fashion as a means to re-establish that credibility.  Secondly, she emphasized that mere product compliance is insufficient in medical product promotion, but that companies need to use such promotion as a tool for educating the public and cited a 2004 Draft Guidance on Help Seeking Awareness on the Part of Drug Firms.  

With these priorities laid out, she then cited the various steps the agency is taking in the new environment.  This included the Draft Guidance on Risk Information and various plans for addressing safety issues.  She admitted, however, that the agency has not mastered the balance between getting safety information out about products and causing unnecessary alarm among the public.  She cited an upcoming workshop to be held this week on Consumer Medication Information and lastly the fact that the agency has announced today that it is finally holding a public meeting about the use of social media to be held in November.  

In all, except for the social media effort, there wasn't a lot of new material here.  However she did outline a lot of new aggressive measures to gather safety information in the coming months, including a program entitled MedWatch Plus that will make it easier to file adverse event experiences on line.  
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