At Madrigal Pharmaceuticals, Inc., we are committed to the essential principles of good corporate conduct and integrity in all of our activities as we focus on delivering novel therapeutics for patients. Establishing and maintaining an effective Compliance Program is a key component of this commitment.
The Office of Inspector General, U.S. Department of Health and Human Services (OIG) issued guidance, outlining the seven key elements of an effective compliance program. Madrigal has developed and implemented our Compliance Program to address each of these elements. Madrigal’s Compliance Program is designed to foster a culture of compliance and mitigate or detect violations of laws or Madrigal policies, recognizing that an effective compliance program must evolve to reflect the changing regulatory environment and growth of the Company.
-
Responsibility and Oversight
Madrigal has designated a Chief Compliance Officer (CCO) to be responsible for the development, oversight, and monitoring of Madrigal’s Compliance Program. Our CCO has independent reporting authority and responsibility to our Board of Directors on compliance-related matters. Madrigal’s CCO has the authority to exercise appropriate professional judgment regarding our Compliance Program, including the development and implementation of revisions and improvements, as needed, to maintain an effective Compliance Program.
Madrigal has also established a Compliance Committee to advise the CCO. The Compliance Committee is comprised of cross-functional representatives of the Company and is tasked with oversight of Madrigal’s Compliance Program.
-
Policies and Procedures
Madrigal’s Code of Conduct sets forth the expected ethical and compliance standards to guide our daily operations. Madrigal personnel are required to certify that they have read and agree to abide by the Code of Conduct, including the key ethical principles and
standards to help ensure compliance with applicable industry laws and Madrigal policies.In addition to our Code of Conduct, Madrigal has developed and implemented policies, procedures, and other guidance to address potential risks areas, including those identified by the OIG. Madrigal personnel are required to certify that they have read and agree to abide by compliance-related policies, procedures, and other guidance, as applicable to their role.
-
Training and Education
Training and education are essential to effectively communicate Madrigal’s standards and requirements to Company personnel, particularly as it relates to their legal and ethical obligations under applicable state and federal healthcare program requirements. Madrigal maintains and monitors training records, ensuring all Company personnel have received the required new hire training and continue to receive periodic retraining.
-
Communication and Reporting
Madrigal is committed to fostering an open dialogue at all levels of the organization regarding ethics and compliance matters. Madrigal personnel are encouraged consult with the Compliance Team regarding questions and report potential compliance concerns without fear of retaliation. Madrigal has established a channel to report potential compliance concerns, which is available 24/7 and allows for anonymous reporting.
- Click: madrigalpharma.ethicspoint.com
- Call: 833-757-9205
-
Auditing and Monitoring
Madrigal’s Compliance Program includes compliance-related monitoring and auditing functions to help evaluate ongoing compliance with applicable policies and procedures. The Compliance Team is responsible for assessing, evaluating, monitoring and auditing identified risk areas on an ongoing basis to ensure the Compliance Program is operating effectively. New legal requirements, business developments, and similar considerations may require new or revised compliance-related monitoring and auditing activities. Relevant findings are reported to the executive team and the Board of Directors.
-
Enforcement and Discipline
All reports of potential compliance violations are investigated in a thorough and timely manner, ensuring any relevant facts and circumstances are understood and considered. Each case is evaluated individually and enforcement is consistent with the appropriate disciplinary action to both address the conduct at issue and prevent or deter future violations.
-
Corrective Action
Madrigal recognizes that even an effective compliance program will not prevent all violations. As a result, Madrigal is committed to determining the appropriate corrective action regarding violations of law or Madrigal policy; Madrigal will work to identify the root cause in order to effectively remediate and prevent reoccurrence, including whether the violation may be due to gaps in Company policies, practices, or internal controls.
As part of our ongoing commitment to ethics and compliance, Madrigal regularly conducts a compliance risk assessment to ensure that our Compliance Program continues to address appropriate compliance risks. Madrigal has developed and implemented an effective Compliance Program, and we will continually work to improve our Compliance Program and all of our compliance-related activities.
STATE OF CALIFORNIA ANNUAL COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
As part of the continued efforts of Madrigal Pharmaceuticals, Inc., we have developed a Comprehensive Compliance Program (CCP) in accordance with the requirements of California Health & Safety Code §§ 119400-119402. Madrigal has implemented elements of a CCP to address certain issues uniquely raised by the California Law. In making this declaration of compliance, Madrigal is asserting that its CCP is reasonably designed to prevent and detect violations of law, regulations, and company policies, and provides for disciplinary and corrective actions when appropriate. We also have established a specific annual dollar limit of $3,000.00 on spending for promotional materials, and items or activities provided to healthcare professionals in California, as required by California law.
To the best of our knowledge, on March 14, 2024, we are, in all material respects, in compliance with our CCP and the requirements set forth in California Health & Safety Code §§ 119400-119402 and annual dollar limit. For a copy of this declaration of compliance please contact Madrigal’s compliance hotline at 833-757-9205 or by email request to [email protected].
To ask questions or comment about this Policy and our privacy practices, our Data Protection Officer can be contacted at: [email protected], or via Our toll-free number: 888-210-2064.