How Pharmaceuticals Can Avoid the Side Effects of Social Media
In highly regulated industries like pharmaceuticals, firms must be particularly vigilant to complying with legal and regulatory requirements when communicating directly with customers and the public over social media platforms.
Dr. Ed Tucker VP and head of Phamacovigilance Operations, Global Medical Safety for Janssen Research & ; Development LLC, a Johnson and Johnson company is charged with compliance, quality and efficiency in the receipt and submission of Individual Case Safety Reports (ICSRs) to national government regulatory agencies. In this interview, Tucker outlines how social media has become an important new tool and communication mode with the public, particularly in accessibility of data and speed, as well as a tool in getting real time market related information.
However, he also discusses how entering the social space can trigger regulatory requirements around the reporting of safety information. Whether it's one-way communication outward, listening to chats, or engaging in two-way dialogue with others on social media, those who discuss medicinal products or information about diseases need to know what is required of them when hearing of a safety issue.
Other new issues about which pharma firms need to be particularly careful in the social media space are assessing reliability of data that comes from social discussions, and ensuring patient confidentialities. One especially tricky area is that the regulations in one country won't be the same in another, so that a different set of laws and regulations may apply when outreach crosses borders.
One use of social tools that Tucker says the industry has not yet taken advantage of yet is patient risk management, in terms of how the Internet could enhance improvement in providing healthcare at a personalized level. Industry specialists have not yet figured out how pharmaceutical companies can be seen as trusted sources to communicate about safety issues to patients, without triggering restrictions related to product promotion.