FDA Guidance Output Plans for 2016

While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several parts of the agency – CDRH, CBER and CDER unveiled plans with respect to the production of guidance documents for the coming year – in some cases notable for what is there and in others for what is not. Here is a brief overview with relevant links.

  • CDRH –  So let’s start with devices. You would think this might be simple and straightforward, but it is not. There is not one list and there is not one category. Rather, the Centers for Devices and Radiological Health (CDRH) published two lists of intended guidance documents for the year – an A list, representing priorities and a B list, representing that which will come about if there depending on time and resources. Each of these is subdivided to address the prospective issuance of Final Guidance documents and the release of Draft Guidance documents. The A and B list can be found here. Current CDRH guidance documents can be found here.
  • CBER – The Center for Biologics Evaluation and Research (CBER) has a much smaller list, divided into only three categories:  Blood and Blood Components lists a potential of six documents, mostly around the topic of preventing transmission of agents through use; Cellular Tissue and Gene Therapy lists three potential documents two of which involve adverse events; and a catchall category of Other which contains only two documents. Current CBER guidance documents can be found here.
  • CDER – The Center for Drug Evaluation and Research (CDER) had the most ambitious list numbering over 100 proposed guidance documents across 15 categories.  Most notably for our purposes in the category of Advertising, there were only four documents, one of which relates to the use of the Internet/Social Media. That one is called “Internet and Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites“.  This one is noteworthy in two respects. First, it is not the first year that this title has been on the list – it is a repeat which might indicate if we were using the CDRH method, this would be a “B-list” item. Second, in previous guidance documents issued during 2014 – and with the infamous release of the 14 Untitled letters affecting 45 brands for banner ads in 2009, FDA has actually already  indicated a good deal about the appropriate use of links. In the former, the agency outlined when use of links to risk information is appropriate where there are character space limitations. In the latter, the agency indicated an area where use of links not appropriate.  Finally with regard to the CDER list, it is s not there. In the 2009 public meeting on use of the internet and digital media for promotional purposes, FDA outlined 5 areas in which they were seeking information so that they could issue guidance. While use of links was one, so was adverse events. Nothing is indicated for 2016 in terms of guidance for that topic, or to address any of the other many holes and questions OPDP has left in the guidance process on this topic. The list of CDER guidance documents can be found here by category.

While this is the plan, as you can see from the A list and B list of CDRH and the repeated topics listed in the CDER list, the plan does not always get executed. While FDA may issue guidance on these topics, being on this list is no sure bet that we will in fact see the document issued this year. We can only watch and wait.

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