I have been working to assemble a data base of FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields. The database now includes hundreds of letters and covers nearly 1000 violations cited by the agency with regard to communications by pharma about medical products.
I tracked several different fields of information. I can sort by company, time period, product, product indication, type of violation, type of communications vehicle, whether or not the product had a boxed warning, and for our purposes today, whether or not it was a digital communications vehicle (web site, social media e.g.) or a traditional medium (print ad, brochure).
For some time, OPDP – and prior to that DDMAC – has been struggling to understand and respond to the regulatory challenges posed by new emerging digital communications platforms, with little to show for it. Accordingly there are a number of outstanding questions about how OPDP regulates communications on the Internet and digital platforms, including social media. For some in industry, the lack of guidance has had a chilling effect on participation in social media and even the Internet, despite the fact that it is a resource to which patients regularly turn for information.
As a result, digital and social media have become a sort of regulatory bogeyman. Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns. So I have used the data base to compare enforcement patterns vis a vis digital communications. For purposes of this paper, I narrowed the search to the years 2008-2012 (inclusive) to coincide with the ascendency of social and digital media use by pharma. For this period, I wanted to see how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.
In short, I asked the data the following five questions:
- What was the frequency enforcement among digital versus nondigital communications vehicles used by pharmaceutical companies?
- What was the comparison of the number of violations involving nondigital communications versus digital communications?
- Was there a greater frequency of more serious violations for digital versus nondigital communications vehicles?
- In looking at a year-by-year breakdown, is the rate of violations related to digital communications increasing with the heightened use of digital and social media?
- What has been the frequency of involvement of social media assets to generate regulatory action letters from OPDP?
You can download the paper here or by clicking on the photo of the cover above.
I hope that the answers to these questions provide a useful basis to help communicators in consideration of their own efforts to talk about medicines in today’s communications and regulatory environment.
The paper has its limitations. For example, the most obvious limitation – since we do not know what proportion of communications by industry is divided between digital and non-digital efforts, the data cannot say whether or not digital is over or under represented. In other words, if 50% of the communications effort is in digital, and it gets 50% of the regulatory action violations cited by FDA/OPDP, then it is proportional – however we have no way of knowing that context.
In the coming weeks, you will find additional analyses from the OPDP action letter data base here on Eye on FDA.