Jill Wechsler

These developments leave pharmaceutical manufacturers in regulatory limbo due to curbs on what firms can tell the public about their products and operations. Widespread interest in pharmaceutical company research findings, product safety, and marketing and production speaks to the need for industry to use the Internet to disclose information as broadly as possible. Yet, regulations that ban manufacturer discussion of off-label drug uses and require full disclosure of product risks limit what manufacturers can say about approved medicines. Industry, as well as the larger healthcare community, want FDA to clarify how its rules on drug marketing and promotion can fit the age of instant Internet communications and unfettered public access to information previously limited to health professionals. FDA officials have been promising guidance in this area for several years, but little has emerged so far.

Broad concerns

FDA held a public hearing on the industry's use of social media in November 2009 to address these issues further. Approximately 50 organizations presented their views, including manufacturers, medical website operators, and Internet search engines. They discussed when and how manufacturers can be held accountable for or able to correct erroneous information in online communications generated by third parties; when it is appropriate to use social media to provide links to non-company healthcare and medication information; how social media can facilitate reporting of adverse drug events; and how companies should submit real-time, online communications to meet requirements for agency review. At the top of the agenda was the Warning Letter issue: namely, how pharmaceutical companies could adhere to policies for drug marketing and communications when it is difficult to fully explain drug risks and benefits in a 140-character Twitter posting.

This public discussion about using online and social media outlets to communicate information about drug products has heightened public use of online resources for relevant medical information, according to a May 2011 analysis by the Pew Research Center. A Pew survey conducted in 2010 found that 24% of Internet users have consulted online reviews of drugs or medical treatments, and 4% have posted personal experiences involving a particular drug. Almost one-quarter of Internet users look for drug safety and recall information online, and the numbers are higher for individuals caring for loved ones and for people with chronic conditions or disabilities.

FDA's Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) has been studying concerns and proposals for Internet communications aired at the public meeting and in subsequent public comments with an eye toward providing guidance that will assist industry in adapting marketing practices to the Internet. The agency now plans to develop several guidances on "concepts that have long-term applicability," explained Jean-AhKang, assistant to the OPDP director, at CBI's January Pharmaceutical Compliance conference in Washington, DC. Instead of issuing platform-dependent policies that would apply to posting information on, for example, Twitter or YouTube, which might become outdated quickly by changing technology, the agency is looking to address broader Internet communications issues. These issues include messages with space limitations as found in banner ads or social-media listings; manufacturer accountability for online communications; links to Internet websites; correcting mis-information on third-party websites; and how to meet FDA prenotification policies for real-time communications activity.