Ensure pharmaceutical/life science industry compliance, reduce eDiscovery risk, empower your employees
The Internet and various social communications/social media platforms have increasingly enabled drug and device manufacturers to more actively engage with consumers and healthcare professionals. In fact, life sciences manufacturers now routinely use social networks for collecting information, communicating, and collaborating.
However the Pharmaceutical/Life Sciences industry continues to face issues including data security, tightening industry regulations, and the rising cost of litigation and eDiscovery. Meanwhile, industry researchers, patients and physicians are adopting emerging communication platforms including collaboration applications, new forms of social communications, social media platforms, unified communications, and instant messaging to conduct research and share information.
These new forms of social communication have complicated the ability of pharmaceutical companies to remain compliant with industry regulations around information security, privacy and retention. Companies who do not actively control of all their communications platforms face regulatory penalties, litigation, and negative publicity.
To ensure compliance and reduce eDiscovery risk, companies in the pharmaceuticals industry should first fully understand their current communications infrastructure, including the use of both approved and unapproved social applications, and develop a plan to capture, manage and archive all communications to ensure compliance with FDA regulations.
The Actiance Platform helps organizations meet Title 21 CFR Part 11 and other the various regulations for data retention and management by enabling the capture, archiving, control and management of new social communications channels, social media platforms, and email content.
Key FDA regulatory compliance 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.
Title 21 CFR Part 11
This regulation establishes 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 on Interactive Promotional Media
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.
Bioterrorism Act of 2002
Establishes requirements – including recordkeeping and regulatory agency access – for registration and traceability of select chemicals and toxins that could pose threats to safety and health.