Compliance & Ethics
Uncompromising ethical standards underlie all our business practices
Assertio is firmly committed to conducting its business consistent with all applicable laws, rules, and regulations and with the highest standards of business ethics.
Assertio is committed to maintaining an effective Comprehensive Compliance Program in accordance with 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”). Assertio’s Comprehensive Compliance Program (“CCP”) includes development, communication and training of policies and procedures, performance of periodic compliance audits and monitoring activities, maintenance of mechanisms to foster open communication throughout Assertio, and tracking and investigation of alleged or suspected non-compliance. The purpose of the CCP is to prevent, detect, and remediate violations of law, regulations, or Assertio policies, and to promote a culture of the highest ethics within the organization. The program is regularly evaluated for effectiveness and the need for continuous improvement. It is Assertio’s expectation that employees will comply with our Code of Conduct and the policies established in support of such code. As the HHS-OIG Guidance recognizes, the implementation of such a Program cannot guarantee that improper employee conduct will be entirely eliminated. In the event that Assertio becomes aware of violations of law or Assertio policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
Copies of the Comprehensive Compliance Program for Sales and Marketing Activities and the Annual Declaration for California are available below. You may also contact the Confidential Alert Line if you’d like to receive these documents by mail.
- Comprehensive Compliance Program for Sales and Marketing Activities (May 20, 2020)
- Annual Declaration for California (July 1, 2020)
Our commitment to compliance resonates in everything we do: Corporate Responsibility Statement
An important part of our mantra, advancing patient care, is helping to protect individuals from inappropriate use of prescription products. As such, we are in the process of spearheading as well as joining multiple initiatives, as spelled out in our Corporate Responsibility Statement, which can be viewed or downloaded here.
Commitment to Transparency
At Assertio we are focused on delivering safe and effective medicines to patients and physicians. To ensure the availability of new treatment options, we may work and innovate with other individuals and organizations including physicians and teaching hospitals. We are fully committed to the financial transparency of these relationships and to prevent any real or perceived conflict of interest.
Under federal law and implementing regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS) any payment or other transfer of value we make to a physician or teaching hospital is subject to collection and potential public reporting. Certain states have also enacted laws and regulations relating to transparency of interactions with healthcare professionals, which often cover additional categories of healthcare professionals, and are separate and in addition to the federal transparency reporting requirements. We are committed to complying with state and federal laws and regulations today and in the future. Inquiries should be directed to Assertio Compliance at complianceofficer@assertiotx.
Reporting Suspected Violations
Every director and employee has a responsibility to report any suspected violations of the CCP, the Assertio Code of Conduct, or any violation of law, regulation or ethical principles that occur within Assertio. Every director and employee may make such reports without fear of retaliation. In most cases, employees should discuss a possible violation with their immediate supervisor, Human Resources and/or Compliance and directors should discuss a possible violation with the General Counsel or Chair of the Audit Committee. However, if you believe that your concerns cannot be addressed in this manner, you may report suspected violations by calling Assertio’s ethics hotline. The ethics hotline number has been made available to all Assertio board of directors and employees via this website, the Assertio Code of Conduct, and the CCP. Reports can be made, at any time, confidentially and anonymously by calling 800.779.3381 or visiting alertline.com.
The ethics hotline is managed by an outside, independent service provider and all calls will be treated (to the extent possible) confidentially and, if requested, anonymously. Identity may have to be disclosed to conduct a thorough investigation and to comply with legal requirements. Where we have a separate policy that provides for reporting of a suspected violation of that policy, you may follow the reporting procedures in that policy or in the Code of Conduct.
Should an individual not be comfortable speaking with Assertio Compliance, or is not satisfied with Assertio Compliance’s response, the individual is encouraged to contact the Chair of the Audit Committee in writing at:
Chair of the Audit Committee
100 SOUTH SAUNDERS RD.
LAKE FOREST, IL 60045
Product Complaints and Adverse Event Reporting
Assertio has implemented procedures which allow product complaints and adverse event information to be reported to the company. This may include information regarding an adverse event experienced by a patient who is currently using, or who recently used, an Assertio product. The procedures in place allow product complaints and adverse event reports to be documented and handled in accordance with applicable laws and regulations. Directors and employees who become aware of an adverse event or product complaint must report it by calling 1.866.458.6389 within one (1) business day of becoming aware of the potential adverse event or product complaint.
Transparency in Supply Chain’s Act Disclosure
Assertio is committed to ensuring that our supply chain reflects the Company’s values and respect for human rights and the environment. Assertio’s relationships with suppliers are based on lawful, efficient and fair practices. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment and protect environmental quality. In furtherance of this policy, Assertio obligates its suppliers by contract to comply with all applicable laws and regulations, including those relating to slavery and human trafficking of the country or countries in which they are doing business.
To anonymously report any known or suspected violation of our internal compliance program, ethical commitments, responsibility charters or other applicable laws, rules or regulations, call 800.779.3381 or visit alertline.com.