This post was written by Kevin M. Madagan and Jennifer Pike.
In a recent interview published by Pharmalot, the Director of the FDA Office of Prescription Drug Promotion (OPDP), Thomas Abrams, indicated that the long-waited draft guidance on the promotion of medical products using the Internet and social media is forthcoming. According to Abrams: “The development and issuance of guidance for social media is among the highest of FDA’s priorities.”
With other agencies issuing social media guidance over the past year (e.g., FTC, SEC), it is hard not to believe Abrams. However, some skepticism is warranted because the industry has been waiting for FDA’s promises about forthcoming Internet-related guidance for almost two decades now. Indeed, the recent Abrams interview reminds us of the absurdist play by Samuel Beckett, Waiting for Godot.
Our wait began in 1996 when FDA held public hearings on Internet advertising and promotion, but then failed to issue any guidelines and subsequently halted all such work. In 1999, FDA further delayed taking a position by informing the industry that it would look at Internet issues on a case-by-case basis, while reserving the right to reevaluate the need for regulations in the future.
A full decade later, in 2009, FDA acknowledged the special nature of the Internet as a marketing tool, and expressed renewed interest in addressing use of the Internet for marketing communications. FDA even held a public hearing in November 2009 and solicited written comments through a public docket, promising that it would issue guidance in 2010. Over the past three years, FDA has been drafting multiple guidance documents to address specific promotional activities involving the Internet and social media. These guidance documents are apparently designed to focus on many questions for which the drug and device industry has been left without guidance, including how to deal with space limitations, fulfilling post-marketing submission requirements, online accountability, use of links on the Internet, and correcting misinformation. In his recent interview, Abrams stated that FDA has identified relevant issues, including, “using vehicles that have space limitations for promotion of prescription drugs, appropriate use of links, fulfilling regulatory post-marketing submission requirements of all promotion materials, and correcting misinformation on independent third-party websites.”
We commend FDA for working on these important issues.
But as a practical matter, since the inception of the Internet, the FDA-regulated drug and device industry has been left on its own, without formal FDA guidance, to determine how traditional statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to the Internet and rapidly evolving technologies. In attempts to ascertain FDA’s Internet and social media policy concerning product promotion, the drug and device industry has been forced to scrutinize individual enforcement actions against companies that have created and used Internet websites and social media for promotion of their products. Interpreting FDA enforcement letters can be a tedious process.
In response to the question of why it has taken FDA so long to issue guidance documents, Abrams pointed to the concern that technology, the Internet, and social media is constantly and consistently changing:
It takes time because we follow good guidance practices and we want guidances that are well vetted and really address relevant issues, and stay relevant for a time period. It would be easier to come out with a guidance in a shorter time that may not be relevant as technology changes. One thing we know is that we can’t predict it, but we know technology is going to keep changing quicker and quicker. So we want this guidance to be applicable, regardless of which technology platform comes in the future or changes that existing platforms may make in the future. [pharmalive.com]
But when asked specifically for an actual date when industry can look forward to formal guidance from the FDA, Abrams was less clear:
We are striving to make it as soon as possible. I’ll be honest with you. As soon as we’re able to issue these – we’re not waiting for a deadline or we’re not waiting for an event to occur. We are working very, very thoroughly and very hard – people are putting in extra hours . . . And as soon as we can issue these, we will issue them. We are as anxious to issue them as industry is anxious to receive them. So we’re not waiting for a deadline or a timeframe. As soon as they are ready and we are happy they are good products that are well vetted and will remain relevant for a good time period, we will issue guidance. [pharmalive.com]
Despite FDA’s assurances that it is working on multiple guidance documents, the drug and device industry is left in the same, familiar position it’s been in for the past two decades: anxiously waiting for formal guidance from FDA.
You’re not alone if you are starting to feel like one of the main characters in Waiting For Godot:
“ESTRAGON: I can't go on like this.”
“VLADIMIR: That's what you think.”