Important Notices

Educational grants submitted today can be considered for events starting on September 8, 2017 or later.

How to Add a Third Party

Apply or Check Status of a Grant Application

-Log onto www.pharmaedgrants.com
-Sign in with registered username and password

 

For General Questions

Contact:
Phone: 1-800-746-6998
Email: JBIgrantsoffice@its.jnj.com

 

California Compliance Policy and Declaration

NOTICE: this information is provided pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765), which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of their products.

  1. I.   INTRODUCTION

  2. Janssen Biotech, Inc. ("JBI") has established a program designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products. Additionally, JBI recognizes that adherence to these standards can be furthered through a compliance program that is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the U.S. Department of Health and Human Services (the "OIG Guide"). The OIG Guide advises that effective compliance programs are comprised of seven elements. As described below, these elements form the basis of JBI's program for compliance with the standards regulating the marketing and promotion of its products.

  3. II.   OVERVIEW OF COMPLIANCE PROGRAM

    1. Written Policies and Procedures

    2. JBI has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. Among these standards are recognized industry codes of conduct including the PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code) published by the Pharmaceutical Research and Manufacturers of America (PhRMA). JBI has established written policies that govern activities involving communicating with customers about the appropriate use of our products; advancing scientific and educational activities; and supporting medical research and education. These policies include:

      Policy on Educational Grants and Research Grants

      JBI may provide grants for specific educational purposes that benefit patients and customers. These may include, but are not limited to, continuing medical and paraprofessional education programs, fellowships provided to teaching institutions and similar organizations with a demonstrated commitment to scientific and technical education, and programs operated by organizations that provide high-quality, nationally recognized patient education. Funding of educational programs will generally be provided only to organizations and institutions and not to individual practitioners.

      Research grants to support customer-initiated research may be provided for programs involving research in areas of legitimate interest to the company. All requests are subject to scientific review prior to funding approval.

      Policy on Charitable Contributions and Patient Assistance

      JBI will consider charitable contributions and requests for patient assistance in the areas of children's health, health care education, access to health care and community responsibility, consistent with JBI policies.

      Policy on Travel Expense Reimbursement for CME, Promotional, or Product Training Meetings

      JBI will, with very limited exceptions that are in accordance with nationally recognized standards, not reimburse for travel and lodging expenses of attendees at promotional and educational programs.

      Policy on Business Meals

      JBI may occasionally offer a modest meal, consistent with the standards of the PhRMA Code, as part of an educational presentation or a business discussion. Venues that feature entertainment or recreation, and attendance by spouses or guests, are not permitted. Modesty is to be judged by local standards, but in general cost of meals with customers should not exceed $25 for breakfast, $50 for lunch or $125 for dinner.

      Policy on the Provision of Educational and Practice-Related Items

      On occasion, JBI representatives may provide items designed primarily for the education of patients or healthcare professionals (for example an anatomical model or medical text) if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities and are infrequent.

      Promotional items such as coffee cups, pens, and notepads, and practice-related items that are not educational are not permitted under JBI policy.

      Total Annual Dollar Limit for Meals and Educational or Practice-related Items

      JBI, has established an annual limit of $2,500 for meals and educational items as the aggregate value of the items or activities that may be provided to California health care professionals pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765).

      Policy Prohibiting Entertainment

      It is the policy of JBI not to provide Entertainment (e.g. sporting events, golf outings, concerts, hunting, etc.) to customers.

    3. Assigned Compliance Officer

    4. JBI has appointed a Health Care Compliance Officer. Our Health Care Compliance Officer has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.

      JBI has appointed a Health Care Compliance Committee. The committee is comprised of the company's Health Care Compliance Officer and members of the company's management team. The Health Care Compliance Committee is the Health Care Compliance leadership team.

    5. Training

    6. JBI has an annual Health Care Compliance training process that includes testing and annual certification of appropriate employees. The training covers applicable guidelines governing our compliance program. Employees are also trained on the consequences of failure to comply with the requirements of the company's compliance program.

    7. Communication

    8. JBI encourages open and candid discussion between management and employees regarding any compliance concerns. JBI employees are encouraged to report their concerns to their manager, to the Human Resources Department, to the Law Department or to the company's Health Care Compliance Officer.

    9. Auditing and Monitoring

    10. JBI self-assesses and periodically audits its compliance with its policies and procedures.

    11. Enforcement and Disciplinary Guidelines

    12. JBI requires a prompt and diligent response to potential violations of the company's compliance program, including its standards regulating the marketing and promotion of our products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.

    13. Responses to Detected Problems and Actions to Correct Issues

    14. JBI requires a prompt and diligent response to potential violations of the company's compliance program, including its standards regulating the marketing and promotion of our products. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.

  4. III.   DECLARATION FOR CALIFORNIA COMPLIANCE LAW

  5. As part of Janssen Biotech, Inc.'s ("JBI") ongoing efforts in the area of compliance, we have developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products. To our knowledge as of the date of this declaration, JBI is in compliance with our Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402.

    Dated: January 1, 2009

  6. IV.   OBTAINING A COPY OF COMPREHENSIVE COMPLIANCE PROGRAM AND DECLARATION OF COMPLIANCE

  7. If you would like Janssen Biotech, Inc. to send or fax a copy of the Comprehensive Compliance Program and Declaration of Compliance, contact us toll-free at 877-468-6720.