1. Corporate Compliance
Rhythm Pharmaceuticals, Inc. (“Rhythm”) has developed and implemented a Comprehensive Compliance Program designed to comply with all applicable federal, state, and industry guidelines relating to the marketing and promotion of our products to healthcare professionals, including the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (the “HHS-OIG Guidance”), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (the “PhRMA Code”) and the California Health & Safety Code sections 119400-119402 (the “Compliance Program”).
2. Overview of the Comprehensive Compliance Program
The Compliance Program, described in further detail below, contains policies, procedures, and processes to address the risk areas identified in the HHS-OIG Guidance and the PhRMA Code. As recommended by the HHS-OIG Guidance, the Rhythm Compliance Program has been designed to fit the specific compliance needs of the company. Rhythm will regularly review and evaluate its Compliance Program so that it continues to meet the evolving needs of the company.
Rhythm has established a program designed to foster: (1) ethical interactions with healthcare providers, and (2) promotion and marketing practices that are in compliance with applicable federal and state laws and industry standards, as described above.
3. Acting Chief Compliance Officer and Compliance Committee
Rhythm has designated a Chief Compliance Officer who is charged with the responsibility of developing, implementing, monitoring, and updating Rhythm’s Compliance Program. The Chief Compliance Officer has the authority to effectuate change and exercise independent judgment within the company. The Chief Compliance Officer is a member of Rhythm’s executive leadership team and makes regular reports regarding compliance matters to Rhythm’s Compliance Committee and Board of Directors.
Rhythm has also established a Compliance Committee comprised of senior management personnel from a variety of business units, as well as legal counsel. The Compliance Committee advises and assists the Chief Compliance Officer in the development, maintenance and updating of the Compliance Program.
4. Written Standards
Consistent with the HHS-OIG Guidance, Rhythm has established written policies and procedures to foster compliance with the PhRMA Code, and other complementary policies that outline the company’s commitment to compliance and corporate accountability. The standards set forth in the policies apply to all Rhythm employees, contractors and agents, and failure to comply with such policies and procedures may result in disciplinary action, up to and including termination.
5. Education and Training
All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the Compliance Program, applicable federal and state laws, regulations and industry guidance, and relevant Rhythm policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual compliance training is required for all Rhythm employees. Rhythm regularly reviews and updates its training programs to confirm the training continues to meet the educational needs of its employees.
6. Effective Lines of Communication
Rhythm is committed to open dialogue between management and employees. Rhythm’s goal is to foster an open-door policy to encourage employees to ask questions or report potential instances of inappropriate activity without fear of retaliation. The company has established a confidential and anonymous Compliance Hotline number that is available 24 hours a day, seven days a week for making good faith reports of known or suspected violations. Any such report relating to this Compliance Program may be directed to the Compliance Department through any of the following means:
Compliance Hotline: 866-515-9466
Compliance Email: [email protected] (non-anonymous)
Employees may also report potential violations to their supervisor or Human Resources.
7. Auditing and Monitoring
A key purpose of the Compliance Program is to prevent and detect violations of law or company policy. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. Nonetheless, it is Rhythm’s expectation that all employees will comply with the Compliance Program and the policies established in support of such program. All Rhythm employees have a duty to promptly report any violation of the Compliance Program or any company policies using any of the available company resources. In the event that Rhythm becomes aware of violations of law or company policy, it will promptly investigate the matter and take appropriate corrective action to ensure the integrity of the Compliance Program and prevent future violations. Personnel who violate Rhythm’s policies and procedures and applicable state and federal laws may be subject to disciplinary action, up to and including termination.
8. Responding to Potential Violations
Rhythm recognizes that a comprehensive auditing and monitoring plan is critical to maintaining the effectiveness of a Compliance Program. The nature of Rhythm’s reviews as well as the extent and frequency of the Company’s compliance monitoring, auditing and evaluation may vary according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations. As appropriate, auditing and monitoring results will be reported to senior management to help guide Rhythm’s risk assessment process.
9. Annual Aggregate Dollar Limit in California
Rhythm does not permit gifts, promotional materials, items, or activities that are prohibited by the PhRMA Code, HHS-OIG Guidance, or related federal or state laws or regulations. For items and activities that are not prohibited, Rhythm has set an annual aggregate spending limit of $2,000 for 2024 per medical or healthcare professional in California, as required by California law. This amount represents an upper limit rather than a spending goal or a usual, customary, or typical amount for medical or healthcare professionals. This limit excludes amounts attributable to product samples, financial support for continuing medical education that conforms to HHS-OIG Guidance and the PhRMA Code, and payment at fair market value for legitimate professional services. In setting this limit, Rhythm has taken into account the size of the company and its product portfolio and may revise this limit as the company and/or product portfolio changes.
10. Rhythm Declaration of Compliance
Declaration Under California Health and Safety Code §§ 119400-119402
Rhythm declares that, to the best of its knowledge and based on a good faith understanding of the statutory requirements, as of September 2024, it is in compliance with its Compliance Program, including its established annual aggregate spend limit of $2,000 per California medical or healthcare professional and the requirements of California Health and Safety Code sections 119400-119402. This declaration is based upon an analysis of information available as of the date of this declaration.
Effective: September 2024
This is a summary document and does not include all the policies and procedures that comprise the Rhythm Comprehensive Compliance Program. Rhythm is committed to conduct the ongoing assessment that is necessary to ensure an effective Compliance Program which may be amended, altered or revised from time to time as needed and without prior notice.
To obtain a printed copy of this document please contact [email protected] or call (857) 264-4280.