The life sciences industry is highly regulated on the federal, state, global and, in some cases, local levels, and non-compliance can cost companies hefty fines and other sanctions.
In order to avoid these pitfalls, companies must have proper systems and procedures in place to help mitigate their risks. Taking inventory of your company's risk mitigation procedures, and making sure they are in line with current enforcement trends, is the key to avoiding costly penalties.
Life sciences companies face a multitude of risk areas, including off-label promotion, federal, state and global transparency requirements, theft/loss reporting and the threat of bribery and corruption. In order to develop and implement a comprehensive risk management plan and an effective anti-bribery and anti-corruption program, companies must not only have an understanding of these regulatory and global legislative requirements, but also have an understanding of the risk areas that regulating agencies have prioritized.
In order to create a compliance program that is designed to stay in tune with current and evolving enforcement trends, companies need to have easy access to up-to-date information. While studying statutes, codes and regulations is a good starting point, enforcement documents issued by regulating agencies provide insight into an agency's enforcement priorities. Documents such as Corporate Integrity Agreements, Deferred Prosecution Agreements, Warning and Untitled Letters and Establishment Inspection Reports are valuable resources to help determine compliance risk areas. Companies that have access to this knowledge are in a better position to implement current and effective compliance programs.
In the past few years, the federal government has passed a variety of wide-sweeping laws that affect the life sciences industry, such as the Sunshine Act and the Drug Quality and Security Act (DQSA). These laws lay the foundation for a multitude of compliance considerations and operational challenges for life sciences companies. It is likely that these federal requirements will have a trickle-down effect to the states and cause additional revisions in those jurisdictions.
How We Can Help
Porzio Life Sciences provides a variety of services and solutions to help with your risk mitigation challenges. Our compliance tools, such as the Enforcement Actions Databases of the Porzio Compliance Digest, assist in your research efforts by summarizing lengthy enforcement documents (CIAs, DPAs, Untitled and Warning Letters, etc.) in an easily searchable manner. Companies looking for hands-on assistance would benefit from our various compliance services offered, such as our state, federal and global reporting and distribution licensing services.
Companies that choose PorzioLS will also benefit from the years of experience our team members have in dealing with compliance issues. Our team includes members with years of in-house experience, so we understand, first hand, the challenges your company is facing on a daily basis.