Online monitoring and the pharmaceutical industry
In April of 2002 I was interviewed by Wired Magazine for a report entitled “Why are drug firms silent online?” At that time many pharmaceutical companies had policies limiting or outright banning their official monitoring of the Web, especially the fast growing blogosphere and emerging uncharted realm of consumer generated social media. The reason? Lack of regulatory clarity, particularly regarding the issue of adverse event reporting requirements for content found when formally tracking this vast space.
Then as is now, all pharmaceutical companies had employees following online conversations and commentary referencing their brands and related treatment areas. Official or not, company employees bound by regulatory reporting requirements were reviewing online content and there was little most companies could do to change this situation. Still, it took some leaders in the industry several years to come to grips “officially” with this challenge.
Starting in 2001, our firm began developing systems and approaches to Internet monitoring which helped to ensure regulatory reporting compliance with comprehensive tracking of Web content; this content included blogs, social media and other potentially influential dialogue spaces. We dedicated analysts and senior counselors to specific therapeutic areas like mental health, respiratory illness and cardiovascular disease. Our team members received annual training in U.S. Food and Drug Administration (FDA) adverse event reporting, off label promotions and other regulatory requirements and industry policy issues.
Today, we help our clients digest the vast volume of consumer generated media and other online content with smart systems and smart people. Our company seeks to identify relevant and influential content, then organize and report these items in a manner which can be effectively and responsibly used by senior industry brand strategists, issues and policy managers. These clients include major pharmaceutical brands, patient advocacy groups and professional trade associations. They use our information with confidence that they are in full compliance for reporting adverse events and addressing other related regulatory issues.
Last November we testified at the FDA hearing on promotion of regulated medical products using the Internet and social media tools. Reflecting on our ten years of experience monitoring online environments for specific therapeutic areas and the pharmaceutical industry as a whole, we cautioned on the challenges of effective and responsible online monitoring and corresponding regulatory reporting requirements. We noted:
"Data from these sources, appropriately evaluated, can provide insights into potential adverse event issues linked to specific treatments. However, a critical challenge is culling actual patient and/or healthcare professional adverse event related content online from other influencer content. Alternative product, litigator and off-shore pharmacy marketing interests are among the sources which influence adverse event related content found on the web…(these adverse event related claims) may be processed by online patients, caregivers and healthcare professionals to form opinions that drive treatment adoption and/or compliance actions.."
In our testimony, we cautioned that without adequate training and experience, marketers and regulators reviewing online monitoring data may decide to take actions based on inaccurate information -- information that may not reflect the real experiences or concerns of actual patient communities. The challenges for providing accurate market analysis and responsible online monitoring today has expanded; our company now covers spaces and technologies the FDA has yet to fully evaluate like iPhone and other mobile platform “apps” and increasingly accessible Deep Web content via The Cloud.
Our experience has been that all our clients, especially pharmaceutical companies, seek to responsibly use this data to in best interests of the patient communities they serve. Our clients are fastidious in their demands for compliance with both regulatory requirements and industry standards when it comes to their online activities.
We hope that public officials and other influencers continue to broaden their understanding of the full range of social and new media, and fully explore the implications of these technologies on regulatory and policy issues for the pharmaceutical and medical device industries. Ultimately, we hope that they will provide guidance and public encouragements based on the best interests of patients and their families. The public interest will be best served with guidance, policies and regulations which encourage full, appropriate and compliant participation by all those who influence patient and caregiver treatment decisions, rather than those which narrowly define and create unreasonable risks for responsible participation.
When it comes to monitoring the Web today or the emerging complex digital environments of tomorrow, we will strive to be a trend-setting source for responsible, effective and compliant information gathering for treatment providers, patient advocacy and government officials.