Compliance
Compliance
Valinor Pharma, LLC Compliance Program
Valinor strives for the highest standards of corporate conduct and is committed to establishing and maintaining an effective and comprehensive corporate compliance program. As a part of this effort, we have adopted a compliance program that addresses the matters covered by the May 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”), which was developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”). The OIG Guidance gives broad discretion to manufacturers in the development, design and definition of scope of a compliance program.
Our Compliance Program’s purpose is to assist Valinor in maintaining compliance with the laws, regulations and company directives and guidance that apply to our products, to train our employees on these matters and to prevent, detect, and correct instances of non-compliance. Valinor expects that our officers, employees and agents will comply with all applicable Valinor directives, policies, and guidance, as well as the related laws, regulations, and health plan program requirements. In the event that Valinor becomes aware of non-compliance, we will investigate the matter and, where appropriate, take disciplinary action, up to and including employee termination, and implement corrective measures to prevent future non-compliance.
Valinor’s Compliance Program is dynamic; we intend to regularly review and modify our Compliance Program to meet our evolving compliance needs. Accordingly, the Compliance Program may be amended or revised by Valinor from time to time.
1. Leadership and Structure
Valinor's Compliance Lead has overall responsibility for oversight of Valinor’s Compliance Program. The Compliance Lead has been vested with the authority relating to compliance within the organization and shall exercise independent judgment concerning these matters. In this role, the Compliance Lead reports directly to the Chief Executive Officer and makes reports to the Board of Directors concerning operation of the Compliance Program.
2. Written standards
Valinor has implemented written policies and procedures that provide employees with the necessary guidance to act ethically and in compliance with applicable laws, regulations, and industry guidelines when conducting business on behalf of the company.
Annual Spending Limit
Valinor also has established guidance regarding appropriate interactions with health care professionals. It is Valinor’s policy to comply with the Pharmaceutical Research and Manufacturers of America (PhRMA) “Code on Interactions with Health Care Professionals,” dated January 1, 2022, which includes limits on gifts, meals and other activities with health care professionals.
For purposes of complying with the California Health and Safety Code 119402, Valinor has established a maximum annual aggregate dollar limit of $2,500 for gifts, promotional materials or activities provided to California health care professionals. This dollar limit represents a spending cap, not a goal or average, and typically the amount spent per physician is anticipated to be substantially less than this maximum amount. Waiver of the limit would require the approval of the Compliance Lead.
To attempt to assure that health care professionals (“HCP”) fully understand our products, Valinor representatives may take time to explain the benefits and risks associated with them, as well as the relevant clinical efficacy studies and mechanisms of action, where appropriate. Some of these informational and educational presentations may take place over the course of a modest meal to avoid taking HCPs away from important time with their patients.
On occasion, Valinor may provide medically relevant and patient-oriented items to HCPs that conform to the PhRMA Code. Some examples include anatomical models, patient education charts and information that is useful for patients in understanding or managing their condition and/or treatment.
3. Education and Training of Valinor Staff
A critical element of our Compliance Program is education and training. Valinor is committed to implementing programs to effectively communicate our directives and guidance to affected personnel in a timely manner. New personnel will receive such training as part of their initial training and existing personnel are expected to receive compliance training on at least an annual basis. Moreover, Valinor will review and update its training programs periodically, as well as identify additional areas of training on an ongoing basis.
4. Internal Lines of Communication
We expect Valinor employees, officers and directors to promptly report suspected, planned or actual violations of our directives and guidelines and/or laws which govern our commercialization activities. We encourage reports to be made to a supervisor, manager, or directly to the Compliance Lead. If these individuals are not available or if the reporter prefers, reports of violations, including those from outside the company, may be made on an anonymous basis to by calling 1-800-625-8817.
We also encourage our employees, officers, and agents to ask questions about any activity where they are unclear about a potential violation or application of our Compliance Program. Questions may be posed through any of the established channels.
Acts of retaliation or retribution against an employee or officer who in good faith reports a potential, suspected, planned or actual violation or application of our directives and guidelines and/or laws which govern our activities are not permitted and will be dealt with appropriately.
5. Auditing and Monitoring
It is a role of the Compliance Lead to develop a plan for auditing and monitoring compliance with Valinor's Compliance Program and the implementation of related directives and guidelines. These audits are intended to identify potential or existing problem areas and to take corrective measures in an effort to prevent the recurrence of non-compliance. The nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices and other considerations.
6. Responding to Potential Violations
An additional role of the Compliance Lead, or a designee, is to oversee the review of non-compliance reports and determine whether further investigation is necessary. Audit findings also are reported to the Compliance Lead. When deemed necessary, the Compliance Lead, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation of Valinor’s directives and guidelines has occurred. As necessary to evaluate a report, audit findings, or to undertake further investigation, the Compliance Lead may request the assistance of outside experts or legal counsel.
7. Corrective Action Procedures
Another role of the Compliance Lead is to oversee the implementation of corrective measures in response to non-compliance with Valinor’s directives and guidelines. Corrective measures take into account the findings of reviews of non-compliance, and may include appropriate and consistent disciplinary action regardless of the individual’s position within the organization (up to and including termination), assessing whether enhancements should be made to our policies, practices, training, or internal controls, and taking action to prevent future non-compliance.
Valinor is committed to compliance and continually strives to monitor and improve compliance with respect to Valinor’s directives and guidelines.
Declaration
As part of Valinor’s continuing commitment to corporate compliance, Valinor declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code sections 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. As of the date of this declaration, Valinor believes it is in compliance with its Compliance Program in all material respects.
Consistent with Valinor’s understanding of the California statute, this declaration is limited to those activities undertaken by Valinor that are directed to California. Valinor makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design, and definition of the scope of compliance programs.
Copies of this declaration and the Compliance Program may be obtained by calling 1-800-625-8817.
Dated: March 12, 2024
Wholesale Acquisition Cost Information for Connecticut Prescribing Practitioners and Pharmacists
MOVANTIK® (naloxegol)
Connecticut law requires pharmaceutical representatives to disclose in writing to Connecticut prescribing practitioners and pharmacists the list price (i.e., Wholesale Acquisition Cost or “WAC”) of marketed legend drugs when engaging in prescription drug marketing in the state. This disclosure provides the WAC price for the products listed below.
|
NDC |
Product |
Dosage Form |
Strength |
Unit Size |
Wholesale Acquisition Cost* |
|
82625-8801-1 |
MOVANTIK® |
Oral Tablet |
12.5 mg |
30 Count |
$415.61 |
|
82625-8802-1 |
MOVANTIK® |
Oral Tablet |
25 mg |
30 Count |
$415.61 |
|
82625-8802-3 |
MOVANTIK® |
Oral Tablet |
25 mg |
100 Count (HUD only) |
$1,385.40 |
The price paid by patients to acquire the product listed is often different than the WAC price listed, and most patients do not pay WAC. How much a patient will pay will depend on the patient’s insurance coverage.
*Pricing as of January 1, 2024. The pricing information disclosed above represents the WAC price, which represents the manufacturer’s published catalog or list price for a drug product to wholesalers as reported to third-party drug pricing publishers. WAC does not represent actual transaction prices and does not include discounts, rebates or reductions in price. Pricing information listed does not imply safety or efficacy of the product.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.