Compliance
Introduction:
At Afaxys Pharma, we believe access to reproductive healthcare should be a right, not a privilege. That’s why, with community and public health providers as our partners, we are driven by our mission to ensure reliable and affordable contraceptive care is available to everyone in a safe and compliant manner.
As part of our mission to serve patient needs, Afaxys® is further committed to compliance with applicable laws, regulations, the PhRMA Code on Interaction with Healthcare Professionals (“PhRMA Code”), and guidance provided by the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) that pertain to the sale, marketing and distribution of pharmaceutical products, and in certain respects, the operation of group purchasing organizations (“GPO”). In addition, Afaxys is dedicated to compliance with the laws, regulations and industry standards governing the reporting of process and reimbursement information for government-reimbursed products.
Based on the applicable laws, regulations, PhRMA Code and OIG guidance, Afaxys has implemented a corporate wide, comprehensive compliance program, which includes policies that help to ensure our compliance. All employees and agents of Afaxys receive training on these policies at hire and on an annual basis.
Elements of the Afaxys Corporate Compliance Program
1. Code of Conduct and Written Policies and Procedures
The Afaxys Code of Conduct (Code) serves as the foundation of the company’s compliance program. The Code provides general guidance regarding appropriate conduct of business activities. Our Policy and Procedure Manual provides specific guidance on our business activities including appropriate interactions with healthcare professionals and customers.
2. Chief Compliance Officer and Compliance Committee
Afaxys has a Chief Compliance Officer (CCO) who is responsible for overseeing the Afaxys compliance program. The CCO provides periodic updates on the compliance program to the Afaxys Board of Directors.
In addition, Afaxys operates a compliance committee, which is chaired by the CCO and is comprised of members of the Afaxys executive team. The committee meets quarterly to review our corporate compliance activities (including training, audits or investigations), review and update our policies and procedures, and to address any compliance-related questions or complaints.
3. Training and Education
Our Code of Conduct, Compliance Manual and Manual of Policies and Procedures are distributed to all employees and agents. Training on the compliance program is provided to all new employees and agents and refreshed on a yearly basis for existing employees/agents.
4. Effective Lines of Communication
Afaxys has a written, open-door policy to encourage candid and honest discussion between employees, agents and supervisors in all departments of the company. Afaxys also operates a compliance hotline and website for reporting anonymously or confidentially any concerns about the conduct of our business activities.
5. Auditing and Monitoring
Our compliance committee works to continuously monitor Afaxys business activities to ensure the company’s compliance with our policies, as well as applicable laws and regulations. The results of audits are reported to the executive team and the Board of Directors.
6. Enforcing Standards Through Disciplinary Guidelines
We take compliance seriously. Our company Code of Conduct, Compliance Manual and Policy and Procedure Manual all include a clear description of the Afaxys disciplinary standards for non-compliance.
7. Non-Compliance and Corrective Action
Under the Afaxys compliance policies, all reported allegations of non-compliance are investigated by the Chief Compliance Officer and reviewed by the compliance committee. Corrective actions are recommended, reviewed and approved by the compliance committee. Where appropriate, corrective actions are implemented to ensure any reported incident is resolved in a timely fashion and to prevent reoccurrence of similar issues.
Disclosures
1. Federal and State Laws
As of the date of this declaration, to the best of our knowledge, Afaxys is in compliance with applicable federal and state laws and regulations, including recording and reporting payments under the Physician Payment Sunshine Act and similar state statutes, that apply to our business. (June 30, 2024)
2. Aggregate Spending Limit
Pursuant to Chapter 8, Section 119402(d) of Part 15 of Division 104 of the California Health and Safety Code, Afaxys has set an annual dollar limit on gifts (defined as anything of value, including meals), promotional materials, or items or activities that Afaxys employees may give or otherwise provide to an individual healthcare provider. Afaxys has set that annual spending limit at $1,500. (June 30, 2024)
3. Annual Declaration for California
To the best of our knowledge, and based on our good faith understanding of the statutory requirements, Afaxys’ is in compliance in all material respects with the requirements of Chapter 8, Section 119402(d) of Part 15 of Division 104 of the California Health and Safety Code, (June 30, 2024)
To report SUSPECTED ADVERSE REACTIONS, contact Afaxys at 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.
