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Comprehensive Compliance Program

Allergan is committed to establishing and maintaining a comprehensive and effective compliance program in accordance with California Health and Safety Code sections 119400 and 119402 and 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"). Our Compliance Program is one of the key components of our commitment to the highest standards of corporate conduct.

The purpose of our 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 Allergan's expectation that employees will comply with the Allergan Healthcare Law Compliance Program, and the policies established in support of such program. In the event that Allergan becomes aware of violations of law or company policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.

Allergan has described below the fundamental elements of our Corporate Compliance Program. As HHS-OIG calls for in its Guidance, we have tailored our Compliance Program to fit the unique environment of our company. Moreover, our Compliance Program is dynamic; we regularly review and enhance our Compliance Program to meet our evolving compliance needs.

Overview of Compliance Program


  1. Leadership and Structure.

    • Compliance Officer. Douglas S. Ingram is our Compliance Officer. We are committed to ensuring that Mr. Ingram, as Compliance Officer, has the ability to effectuate change within the organization as necessary and to exercise independent judgment. Mr. Ingram is charged with the responsibility of overseeing the development, operation, and monitoring of the Compliance Program.
  2. Written Standards. Allergan's Healthcare Law Compliance Program Policies and Procedures Manual is our statement of compliance principles that guide our interactions with health care professionals. Allergan also has a Code of Business Conduct and Ethics, which articulates our fundamental principles, values and framework for action within our organization. Together, the Policies and Procedures Manual and the Code of Business Conduct and Ethics establish that we expect management, employees, and agents of the company to act in accordance with law and applicable company policy. Additionally, as required under Section 119402 of the California Health and Safety Code, Allergan has established an annual company spending limit on promotional items or activities provided to medical or health professionals licensed in California. Allergan's annual spending limit is $1500 for activities occurring between July 1, 2007 - June 30, 2008.

    As permitted under Section 119402, drug samples given to health care professionals intended for free distribution to patients, financial support for continuing medical education and health educational scholarships, and payments for professional and consulting service are excluded from the annual spending limit. In addition, Allergan's annual spending limit does not include items of nominal value ($10 or less), reprints, and items provided for distribution to patients (e.g., patient-oriented health and disease management information).

    The annual spending limit is not intended to serve as a spending objective or goal by Allergan for medical or health professionals in California. Rather, it is intended to establish an annual upper limit on spending that is consistent with Allergan policy. Allergan will review its spending limit on at least an annual basis. Allergan reserves the right to change its spending limit at any time.

  3. Education and Training. A critical element of our Compliance Program is education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements. Allergan is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel. Moreover, Allergan will regularly review and update its training programs, as well as identify additional areas of training on an "as needed" basis.

  4. Internal Lines of Communication. Allergan is committed to fostering dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. We have also established a confidential hotline number for reporting known or suspected violations of the Code of Business Conduct and Ethics.

  5. Auditing and Monitoring. Allergan's Compliance Program includes efforts to monitor, audit, and evaluate compliance with the company's compliance policies and procedures. We note that in accordance with the HHS-OIG Guidance, 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. Allergan's Compliance Program includes clear disciplinary policies that set out the consequences of violating the law or company policy. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.

  7. Corrective Action Procedures. Our Compliance Program requires the company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to prevent future violations.

    Copies of the Comprehensive Compliance Program may be obtained by calling 1-866-246-4425

Compliance Declaration

Allergan declares that on or before July 1, 2005, it has adopted a Comprehensive Compliance Program applicable to California medical or health professionals pursuant to California Health and Safety Code sections 119400 and 119402 and that Allergan will manage its operations and dealings with California medical or health professionals to be in compliance with its Comprehensive Compliance Program and California Health and Safety Code sections 119400 and 119402. Allergan further declares that it is not aware of any violations of its Comprehensive Compliance Program relating to California medical or health professionals on or after the effective date of California Health and Safety Code sections 119400 and 119402 that have not been addressed and corrective action taken. Copies of this declaration and the Comprehensive Compliance Program may be obtained by calling 1-866-246-4425.

2007 Annual Re-Declaration

To the best of its knowledge and based upon a good faith understanding of the applicable statutory requirements, Allergan declares that it is in compliance, in all material respects, with its Comprehensive Compliance Program and California Health and Safety Code §§ 119400-119402 as of July 1, 2007.

To the best of its knowledge and based upon a good faith understanding of the applicable statutory requirements, Allergan is not aware of any violations as of July 1, 2007, of its Comprehensive Compliance Program or of California Health and Safety Code §§ 119400-119402 relating to California medical or health professionals that have not been addressed and for which corrective action has not been taken.

The Office of the Inspector General has recognized in its Compliance Program Guidance for Pharmaceutical Manufacturers, that the implementation of an effective compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. By making this declaration, Allergan is not asserting that in all circumstances it can prevent individual employees from conduct that deviates from its policies. Allergan expects employees to comply with its Comprehensive Compliance Program and has made a good faith effort to enforce its Comprehensive Compliance Program, prevent violations, and address any inappropriate conduct that may occur.