Navigating the complex world of compliance in the life sciences industry can feel overwhelming. Regulations around distribution, transparency, and promotional practices are constantly evolving, making it critical for organizations to stay informed and proactive. That’s where RLDatix Life Sciences’ Porzio Compliance Digest comes in. It’s a powerful compliance resource designed to simplify and streamline regulatory efforts.
In a recent webinar, our RLDatix Life Science experts provided an in-depth look at how the digest helps life sciences professionals stay ahead of compliance challenges.
Let’s highlight the key takeaways from that discussion, including essential databases, compliance tools, and the real-world impact of using the Porzio Compliance Digest.
Porzio Compliance Digest: Your One-Stop Compliance Hub
The Porzio Compliance Digest Dashboard serves as the central hub for compliance teams, offering real-time access to critical regulatory information and industry insights.
- Weekly InfoCenter Updates – Breaking compliance news and regulatory changes are delivered straight to your inbox, keeping your team informed without the need for constant research.
- Benchmark Polling – Each month, we ask our customers a key compliance question and share industry-wide insights, helping you understand trends and best practices.
- Event & Presentation Access – Stay up to date on upcoming industry events and gain access to recorded presentations, offering valuable compliance guidance from RLDatix experts.
Three Essential Compliance Databases
The Porzio Compliance Digest includes a wide range of compliance tools, but in the webinar, we focused on three key databases that are critical for managing compliance risks in today’s regulatory landscape.
1. Transparency & Limitations Database
The Transparency & Limitations Database is designed to help organizations navigate complex laws related to healthcare professional (HCP) interactions, drug pricing disclosures, and marketing regulations. It includes:
- Federal Transparency Requirements – A comprehensive overview of the Sunshine Law, including reporting obligations for payments made to HCPs and healthcare organizations (HCOs).
- State-Specific Laws – Every U.S. state has its own requirements for marketing disclosures, gift limitations, and drug price transparency. The T&L Database compiles these laws into a single, easy-to-navigate resource.
- Industry Codes & Guidelines – Stay compliant with evolving regulations, including PhRMA Code updates and Office of Inspector General (OIG) guidance.
- Compliance Modules & Regulatory Maps – Gain access to tools that summarize key compliance topics and visually map out where laws and pending legislation apply.
With updates as regulations evolve, this database helps ensure that compliance teams never miss a critical deadline or policy shift.
2. Distribution: Trade & Sample Database
Ensuring compliance with distribution regulations is essential for avoiding penalties and maintaining trust with regulators. The Distribution Database covers three core areas:
- Legend Drugs & Controlled Substances – This section provides a nationwide overview of distribution laws, licensing requirements, sales rep registration, and record-keeping mandates.
- Prescription Devices – Includes compliance rules for the distribution of medical devices, licensing requirements, storage regulations, and federal oversight under the Drug Supply Chain Security Act.
- Federal Oversight & Quality Systems – The database also includes federal policies related to supply chain security, device classification, and procedural requirements for compliance audits.
By centralizing the distribution of compliance information, life sciences companies can ensure that their practices align with both state and federal regulations.
3. OPDP Promotional Violations Database
Marketing and promotional compliance is a major area of regulatory scrutiny, and the Office of Prescription Drug Promotion (OPDP) Database helps organizations stay ahead of enforcement actions.
- Searchable FDA Enforcement Actions – This database provides a detailed record of untitled and warning letters issued by the FDA for promotional violations.
- Trends in Compliance Violations – By analyzing historical enforcement actions, compliance teams can identify patterns and common mistakes in drug marketing.
- Best Practices for Promotional Compliance – Stay informed about the FDA’s evolving approach to promotional enforcement and adjust your marketing strategies accordingly.
The OPDP database allows users to search by company name, year, or keyword, making it easy to find relevant cases and gain insights into promotional compliance trends.
Beyond the Webinar: Additional PCD Resources
While the webinar primarily covered Transparency, Distribution, and OPDP, the PCD offers even more compliance support, including:
- HCP Authorities & Restrictions Database – A resource to track prescriptive and sampling authority requirements for healthcare professionals, ensuring compliance with federal and state regulations.
- Government Prosecution & PDMA Inspections Database – Provides access to enforcement cases and inspection trends, helping organizations anticipate compliance risks.
- International Transparency Database – Covers global compliance requirements, including anti-bribery laws, financial limitations, and data privacy regulations for companies operating outside the U.S.
By leveraging these databases alongside the core resources covered in the webinar, organizations can create a robust compliance strategy that reduces risk and ensures regulatory alignment.
Why Compliance Teams Trust the PCD
Regulatory changes are constant, and non-compliance can lead to costly fines, reputational damage, and business disruptions. That’s why compliance teams rely on the Porzio Compliance Digest to provide the latest laws, pending legislation, enforcement actions, and industry guidance all in one place.
With the PCD, organizations can:
- Save time by eliminating the need to manually track state and federal regulations.
- Reduce risk by ensuring marketing, distribution, and transparency practices are fully compliant.
- Stay informed with real-time updates, industry benchmarks, and expert insights.
If you missed the webinar, you can watch the full recording here. Or explore how the Porzio Compliance Digest can support your team by, visiting www.rldatixlifesciences.com.
Let’s simplify compliance together.