Happy New Year. That means that it is that time for some of those look-back postings where we look at what FDA has and has not accomplished in the course of the year we have just been through.
In many respects it has been a banner year. Today we’ll look at the year as it relates to the work of enforcement, specifically through the Office of Prescription Drug Promotion (OPDP). And here we see that enforcement, as expressed through the issuance of Warning and Untitled letters, occurred at an all time low with the issuance of only 9 letters during 2015.
Let’s begin with a brief examination of the violations were cited involving what kinds of companies, products and communications vehicles. Second let’s consider the significance of it all.
Of the 9 letters issued this year, only 2 were Warning Letters while the remaining 7 were Untitled. Of the 9 communications vehicles involved in the violations, 4 were digital properties while the balance involved traditional media.Of the 4 digital properties, 3 of them involved websites and one of them was related to social media – an Instagram/Facebook posting that incorporated risk information by link only.
When it comes to the types of violations, the lack or minimization of risk information continues to be the most common violation, though closely rivaled this year by the citation for unsubstantiated claims.
In addition to the violations related to these letters are the recipients. As noted in an earlier related posting, for the past few years, letters largely involved companies that are lesser known and are likely to have fewer products on the market. Have large companies gotten so good at this that they do not make violations? Is there a policy reason associated with the focus on smaller companies? Are there so few violations being cited by OPDP because they have turned their attention to reviewing materials submitted by companies? Certainly, they are valid questions. Answers are not likely.
Why is any of this important? At least one reason is the unfinished work FDA – and OPDP in particular – in the area of shedding light on the rules associated with digital media. The small amount of guidance put out by FDA on the topic fails to address the breadth and depth of the questions the agency asked in 2009 when it held a two day public hearing on the Internet and social media – a meeting which set the framework for answers to outstanding questions. Not only are there many gaps, but the guidance documents that have been issued raise almost as many questions and they answered. Meanwhile digital media continues to rapidly evolve, bringing new questions into the marketplace. If the agency is silent through the guidance process and silent through the enforcement process then it leaves a large swath of unchartered and unknown territory. That, in turn, leaves a very uneven environment not just for companies, but for patients seeking health information through digital platforms.
And that is the point of view on enforcement in 2015.