(As required by the California Health & Safety Code Sections 119400 – 119402)
Secura Bio, Inc.® (“SECURA BIO”) is a pharmaceutical company committed to developing and commercializing innovative medicines and life-changing products for patients who need them most. We are equally committed to conducting our business ethically and in full compliance with all applicable U.S. laws, regulations, and industry standards.
To support this commitment, SECURA BIO has implemented a Comprehensive Compliance Program (CCP) that is designed in accordance with the Office of Inspector General’s (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers and the PhRMA Code on Interactions with Health Care Professionals. This program reflects SECURA BIO’s dedication to integrity and ethical behavior in all aspects of our operations.
The CCP applies to all SECURA BIO personnel, including the Governing Board, administration, employees, healthcare professionals, contractors, volunteers, and others acting on behalf of SECURA BIO. Key elements of the CCP include:
- Written Standards, Policies, and Procedures that promote compliance with applicable laws and outline the principles and expectations for employee conduct.
- Designation of a Compliance Officer and Compliance Committee tasked with oversight and implementation of the CCP.
- Regular, Effective Training Programs tailored to employee roles, addressing key legal and regulatory topics including the False Claims Act (FCA), Anti-Kickback Statute (AKS), and Federal and State transparency and disclosure obligations.
- Open Lines of Communication to encourage personnel to ask questions, raise concerns, and report potential violations in good faith, with assurances of confidentiality and strict non-retaliation policies.
- Internal Auditing and Monitoring designed to proactively detect, prevent, and respond to violations of company policy, law, or healthcare program requirements.
- Enforcement and Discipline for confirmed violations, with appropriate corrective actions determined and implemented by the Compliance function.
- Marketing Code of Conduct to help us serve patients in an ethical and legal manner
California Spending Limit
In accordance with California Health & Safety Code Section 119402, SECURA BIO has established an annual aggregate dollar limit of $2,000 per calendar year on expenditures for educational items, promotional materials, and meals provided to medical or healthcare professionals licensed in the State of California.
California Declaration of Compliance
To the best of its knowledge and based on a good faith understanding of the statutory requirements, SECURA BIO declares that it has established a Comprehensive Compliance Program that meets the requirements of California Health & Safety Code Sections 119400–119402 and is tailored to the Company’s specific risk profile. The Company maintains internal monitoring systems to ensure adherence to its established annual spending limits in California. Accordingly, SECURA BIO declares that it is, in all material respects, in compliance with its Compliance Program and the associated California statutory requirements for the period of January 1, 2024 through December 31, 2024.
Request for copies of Secura Bio®’s CCP can be made by calling (702) 251-0011.