Business Ethics & Compliance
Guided by a strong moral compass and entrepreneurial spirit
At ADMA Biologics, we are dedicated to conducting ourselves with the highest levels of ethics and transparency, not only in our interactions with staff, prescribers, and patients, but also in our partnerships with suppliers. Our commitment to conducting business ethically is at the forefront of our mission to serve immunocompromised patients and others at risk for certain infections. We rely on our principles to direct us towards ethical and responsible choices that enable us to meet the needs of both patients and providers. We embrace our values to guide us in making the right decisions, and we take responsibility for compliance with the laws and regulations that govern our industry. We hold ourselves to the highest standards in achieving this goal. All members of our team embody these values and assume responsibility for ensuring compliance.
Our approach to quality and compliance involves the implementation of Quality and Compliance Committees for our essential functions, such as Commercial, Research & Development/Medical Affairs, and Supply Chain. The unique management oversight encourages proactive risk management, which includes the prompt identification, evaluation, prioritization, mitigation, and escalation of priority and emerging risks.
Company oversight extends to healthcare quality and compliance, business ethics, responsible product marketing, and compliance with anti-bribery/anti-corruption, transparency, and other relevant laws and regulations. Our aim is to promote integrity and advance purpose of serving patients ethically and responsibly. Furthermore, we conduct internal effectiveness reviews and enlist independent third-party experts regularly to evaluate the effectiveness of our Ethics & Compliance Program and compliance governance framework.
Kaitlin Kestenberg is our Senior Vice President of Compliance & Project Operations, responsible for supervising our Ethics & Compliance Program company wide. She reports directly to the CEO and provides regular reports to Company management.
Code of Conduct
ADMA is driven by our values which are at the foundation of our culture and our top priority: Human Connection, Courageous, Dynamic, and Tenacious. Our operations are guided by a code of conduct that helps us make ethical decisions to make a difference in the lives of immune-compromised individuals. The code encompasses a variety of compliance policies, such as anti-bribery and anti-corruption, personal data, human rights, conflicts of interest, social media, responsible marketing and promotional practices, fair competition, anti-harassment, and whistleblower anti-retaliation. All employees are required to comply with the code of conduct and ensure that they act with integrity. Staff is encouraged to raise questions, express concerns, and seek additional guidance.
Policies for US Commercial and Corporate Colleagues
Our business processes provide a comprehensive overview of the regulations, laws, industry best-practices, and policies and guidance that field-based commercial personnel and US non-field personnel must adhere to as part of our commitment to compliance. This guidance is intended to help ensure that field and corporate personnel act ethically and continue to build trust in their interactions with patients, healthcare professionals, and other stakeholders.
Policy on Interactions with Healthcare Professionals
Our pledge to responsible, ethical, and upright conduct in all our business undertakings, encompassing marketing, medical, sales, and research and development activities, is reflected in our business processes on engagement with healthcare professionals. These standards apply to all the geographies we serve, as we strive to enhance care and quality of life for the patients we serve. We also ensure that our business activities align with the highest medical standards and practices.
ADMA Biologics has a Compliance and Training curriculum in place to ensure that all employees comprehend and follow the company's standards and act with integrity. Our training programs incorporate live, virtual, and online formats and prioritize the learner's needs by providing scenario-based materials to increase engagement, relevance, and retention.
We employ analytics in our online training programs to gauge the effectiveness of the training. Each learning module reinforces the importance of the training, explains why it is essential, and emphasizes the organization's commitment to serving immunocompromised patients and others at risk for certain infections with compliance and integrity.
Code of Conduct training is mandatory for all employees and certain third parties when they join, and it is updated regularly with new content and training.
ADMA employees and certain third parties receive training on job specific and other critical policies and practices upon hire and on a regular basis, such as responsible marketing and advertising and anti-bribery/anti-corruption training. Compliance and Ethics training at ADMA Biologics is a part of a comprehensive training program that covers additional topics, including privacy, harassment, protecting sensitive information, lobbying, diversity, equity and inclusion, and product quality, safety, and adverse event reporting. Messages about ethics and integrity, such as communications from leadership and the compliance department, are consistently shared to reinforce ethical behavior and the significance of speaking up with any inquiries or concerns.
ADMA Biologics personnel who engage in discussions with healthcare professionals about our products must ensure that their communications are consistent with approved product information and indications. Any materials used to promote our products must be accurate, substantiated, fair, objective, verifiable, and comply with applicable laws and regulations. When communicating with healthcare professionals, ADMA Biologics personnel will provide a balanced view of the benefits, risks, and limitations of our products. Promotional activities must be approved by appropriate Legal, Medical, Regulatory, and Compliance staff, as needed, and compliance-related questions should be addressed to those functions.
ADMA Biologics may financially support third-party organizations to conduct medical and scientific conferences. The primary objective of these conferences must be scientific exchange or medical education, and they must be held in appropriate venues. Any hospitality offered in connection with these conferences must be suitable and must not involve entertainment or leisure events organized by ADMA Biologics.
ADMA Biologics will not provide financial support to third parties as an incentive for healthcare professionals to use, prescribe, purchase, or recommend our products or to influence clinical trial outcomes. Our sponsorship of third-party medical conferences or similar meetings will be limited to travel, meals, accommodation, and registration, where permitted by local laws and regulations. Moreover, ADMA Biologics will not provide financial support for spouses or guests unless they are qualified to attend.