OR WAIT null SECS
Besides common-sense monitoring of social media activity by pharma, FDA will exercise 'enforcement discretion' in reviewing online activities
“Interactive promotional media” is the catchall term FDA will use to describe social media and blogs, which the Agency’s Office of Prescription Drug Promotion (OPDP) has been wrestling with ever since a 2009 public meeting that brought numerous big guns in the online world, such as Google and Yahoo, to make a case for as much flexibility as possible in allowing pharma-sourced content on the Web. Now, OPDP has issued a proposed guideline on the topic: Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. The document is open for commentary until April 14 at the Div. of Documents Management at www.Regulations.gov.
Social media has been a tough communications channel for both FDA and the pharma industry for two reasons: like any other medium, FDA seeks to ensure that biopharma companies provide “fair balance” of product attributes in communications; and the pharma industry has a particular concern with how to acknowledge, address or react to statements of adverse events (which it is obligated to report, when appropriate). But the fast-paced, ephemeral nature of social media flies in the face of this deliberation. The guidance does not address adverse-event reporting (that might come later, under rule-making FDA is obliged to complete this summer under the FDA Safety and Innovation Act of 2012). For industry-originated content, FDA is proposing these basic rules:
“Responsible for” generally means, OPDP wants to see what was said by the pharma company, or its agents, and will exercise “enforcement discretion,” which generally means that the company can go forward with communications (including things like tweets or blog posts) and OPDP may or may not take action subsequently. An additional section of the guidance tells industry how to file reports with FDA, using an existing Form FDA 2253; in the case of activities like blogs, the form can be filed monthly.
Perhaps the most vital area, however, is what OPDP is signaling it will not attempt to regulate, which is user-generated content showing up in places where the industry is also providing content. Pharma agents can now participate in such third-party sites (such as industry news blogs)—and report its involvement—but is not beholden to FDA for all the content on the site. There are significant gray areas in these rules: if a pharma company has “any control of, or influence on, the third-party site, even if limited in scope, it is responsible for submission to FDA to meet the postmarketing submission requirements.” Does paying for other promotional activity on a site (such as banner ads appearing in the vicinity of a public forum?) constitute “limited influence?” In a similar context, OPDP notes that unrestricted educational grants would not constitute “influence” (and therefore allows the activity to go forward without reporting), but it’s an open question whether the general public would look on the relationship that way.
All in all, it appears that the doors are opening wider for pharma companies’ own bloggers or social media mavens to speak up in social media, with OPDP watching in the background.