FDA Compliance for Communication, Collaboration, and Social Networking
The Actiance Governance Platform helps pharmaceutical companies meet FDA compliance requirements for the use of communication, collaboration, and social networks.
Pharmaceutical companies have traditionally been slow to embrace social business and to adopt the real-time communication technologies that enable efficiencies in communication and collaboration. An assessment of the threat landscape reveals why: Security issues, ambiguity in industry regulations, and the rising cost of litigation and eDiscovery. Meanwhile, patients and physicians are using real-time communication technologies including social media and instant messaging to research, discuss and evaluate their options. Pharmaceutical companies who do not have a strategy for FDA compliance in this area could find themselves left behind the competition.
Below is a summary of the key FDA regulatory requirements:
Federal Food, Drug, and Cosmetic Act
Records retention requirements including ISO 13485 and 21 CFR Part 11 (Electronic Records and Electronic Signatures), and other compliance standards. Companies found not in compliance face warning letters, seizure, injunction, criminal prosecution, and fines. Currently, companies face up to $500,000 for a misdemeanor by a corporation that results in death, or a felony and a maximum prison term of a year for each offense.
Food and Drug Administration Amendments Act (FDAAA) of 2007
Includes the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee and Modernization Act (MDUFMA), the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). FDA has been granted additional powers to conduct complex and comprehensive reviews necessary to new drugs and devices.
Code of Federal Regulations
Title 21 CFR Part 11 deals with FDA guidelines on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
FDA Draft Guidance Report: Fulfilling Regulatory Requirements for Post marketing Submissions of Interactive Promotional Media for Prescription Human an Animal Drugs and Biologics (1/2014)
FDA has opted for a broad definition of ‘interactive promotional media’, which ‘allow(s) for real-time communications and interactions (e.g. blogs, microblogs, social networking sites, online communities, and live podcasts)’ that companies might use to promote themselves or their products. Companies have to submit a copy of their first post on social media to the FDA and thereafter, a monthly update with the names and URLs of the social networks used and the date of the firm’s most recent activity. FDA will hold member companies accountable for its’ employees’ personal social media accounts if they are being used to promote the firm or the firm’s products.
Unified Security Gateway - is the only Secure Web Gateway to combine feature and content controls of social networks alongside the monitoring, management and security of Web 2.0 applications, such as instant messaging, with URL filtering, anti-malware and Web anti-virus protection.
Socialite - enables you to control, regulate and moderate social networking activities. From granular content, features and activity control to the moderation of subject matter posted and the archiving of posts and activities, you can confidently enable. Socialite is available as a module of USG, as a SaaS solution, or as a hybrid (i.e., on-premise and hosted) solution.
Vantage - is used by the world's largest firms to ensure security, management and compliance for Unified Communications - from presence and instant messaging to conferencing and voice - to safely enhance business productivity and responsiveness without endangering network security.