Corporate Compliance
Egalet Corporation is committed to establishing and maintaining an effective 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”). Egalet is committed to transparent and ethical business practices. The purpose of our ethics and compliance program is to prevent, detect, and remediate violations of law, regulations, or Egalet policies, and to promote a culture of the highest ethics within the organization. It is Egalet’s expectation that employees will comply with our Code of Business Ethics and the policies established in support of such code. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. In the event that Egalet becomes aware of violations of law or Egalet policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
California Compliance Law
NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.
Egalet declares that, to the best of its knowledge, and based on a good faith understanding of the legal requirements of California Health and Safety Code § 119400 and 119402, has adopted a Comprehensive Compliance Program with respect to our business and operations in the State of California as mandated by this California law. Egalet has tailored its Comprehensive Compliance Program to its current size and business operations and continues to develop and implement changes to the Comprehensive Compliance Program as compliance and operational needs evolve. To the best of our knowledge and based on a good faith belief, Egalet is in compliance with its Comprehensive Compliance Program.
In accordance with California Health and Safety Code §§ 119400-119402, Egalet has established an annual dollar limit of $2,500 on meals associated with educational presentations, educational items, promotional materials and or other items of value that Egalet may provide to medical or health care professionals in California, as defined in the California statute.
Commitment to Transparency
At Egalet we are focused on delivering safe and effective pain 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 hospital. 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.