For decades, FDA has regulated the labeling and promotion of prescription drugs, devices and biologics – generally requiring detailed risk summaries and the presentation of "fair balance" between benefits and risks. The Internet and social media such as blogs, twitter and YouTube have stressed these traditional regulatory systems which, after all, were created to regulate books, pamphlets and the print media. So, do these old systems fit the new media? How, for example, does one include legally required risk information in a tweet limited to 140 characters?
In an effort to address this growing challenge, FDA recently announced in the Federal Register an opportunity for the public to provide comments on this issue at a two-day public meeting (November 12-13, 2009) and via written comments (due by February 28, 2010).
In this public announcement, FDA identified these five key issues or challenges relating to new communication technology:
- For what online communications is a manufacturer legally responsible under FDA regulations? For example, is a manufacturer responsible for an unsolicited entry onto a company blog?
- How should companies fulfill their risk disclosure obligations in Web sites and social media?
- Can (and should) companies respond to incorrect or even risky information on a third party Web site or in some social media that is outside the company's control such as YouTube?
- When is it appropriate for a company to link into other Web sites, particularly sites that include off-label information?
- What adverse event investigation and reporting obligations do companies have for alleged adverse events discussed on third party Web sites or in other social media?
As the new – and perhaps more technology savvy – FDA strains to keep abreast of these revolutionary changes in communication technology, it remains firmly committed to regulating company communications relating to prescription products and to enforcement of the regulations. In a speech this week, FDA reminded the regulated community that enforcement of promotional rules is a high priority with this administration. This is no idle threat. Earlier this year, FDA issued a number of untitled letters to companies for alleged violations of promotional rules stemming from Web-based communications.
FDA has also reiterated its belief that the current regulatory system remains viable and applicable to these new communication tools. FDA acknowledges that it can benefit from input from various stakeholders to help shape its ongoing approach to regulating these new systems and that stakeholders may benefit from guidance as to how the regulations will be applied. While one can debate whether the old regulations fit the new social media, until FDA says differently, the current rules remain firmly in force.
FDA has been aware of the challenges presented by these new communication systems for a number of years. In 1996, FDA held a similar public meeting on Internet promotion issues. In 2001, FDA issued a draft guidance on safety reporting for drugs and biologics which discusses company obligations for handling adverse event information from Internet sources. (This guidance is still in draft status after eight years but is referenced in the recent Federal Register announcement.)
As companies turn to innovative communication and marketing approaches that capitalize on the power of the Internet and social media, these issues will become more and more important. The FDA has invited the public to supply criteria to consider and research regarding these forms of communication. Interested parties should consider expressing their views at the upcoming meetings or in written comments.