Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.

Educational Grants Process

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is proud to be able to provide grants to support educational activities and programs that help health care professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

• Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.


• Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.


• Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc products.

 

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

1. An assessment documenting why the education is necessary


2. An agenda or brochure describing the schedule of events


3. A detailed budget identifying all sources of funding and how grant funds will be used


4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the policies and procedures of Guidance Document and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Health Care Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc's Medical Affairs or Scientific Affairs Departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, including budget, staff and interactions with educational providers. In addition, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc has:

• Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;


• An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;


• Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc may consider the following factors:
  • The demonstrated scientific and clinical need for the program;
  • Whether the proposed program is sponsored solely by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc or if our funding represents a significant proportion of the program budget;
  • The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.

Frequently Asked Questions
 

1. Why is the grant information being disclosed?

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What grant information is being disclosed?

Beginning in the first quarter of 2008, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is providing the:

• Name, city and state of the accrediting organization


• Co-sponsor to whom the funds were paid, if applicable, and their city and state


• Amount of the payment, the title of the educational activity


• Date the educational activity will be initiated


3. What types of grants does Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc support?


• Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.


• Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc products are discussed as part of such funded activities, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc requires that such discussion be done in a manner consistent with the FDA approved labeling.


• Patient Education: Printed/online educational materials produced for people living with a particular disease or condition.


• Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.


4. Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and has ownership of the educational activity, controlling all aspects of the activity/program. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

5. Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

6. What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

7. How is the total amount of the grant determined and distributed?

The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract.

The disclosure report posted by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is limited to the funding we provided and does not include or address funding secured by the grant requesting organization from sources other than Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The accredited/educational provider has complete control over the distribution of funds received from Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and the choice of co-sponsor(s).

8. What should one be aware of to further understand how the funding amount is being disclosed on our Web site?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

To ensure accurate reporting of funds disbursed, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is disclosing all payments to an accredited/educational provider within a defined fiscal quarter.

9. What types of information is not reflected by the funding amounts we have disclosed?

The payment information posted on this site does not itemize the amount of funds the grant requestor may pay to third parties as "pass-through" expenses associated with building health care provider awareness of the educational activity and conducting the event. Typical pass-through expenses may include; fees (e.g., accreditation/certification, fees CE certificates, sub-contractors, medical societies, etc.), administrative costs (e.g., printing, postage, etc.), logistical support (e.g., room rental, audiovisual equipment rental, etc.), faculty honorarium and travel expenses, and other expenses.

10. Why do some funds appear to have been reported for the same amount across multiple quarters?

All reporting is based on actual payments made, not on total dollar amounts approved for each grant request. There may be certain situations where grant requests are approved with installment payments of equal or similar value spread over time. Usually these will occur when more complicated educational activities with multiple components are approved. Payments are disbursed upon completion of project milestones that demonstrate the activity is proceeding as originally proposed, as defined by the accredited provider/educational sponsor.

11. Is the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. In addition, changes in the availability of Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc funds affect the volume and dollars available for grants.

12. What is the difference between a charitable contribution and an educational grant?

Educational grants are provided for bona fide educational activities and fall into one of the following categories:

• Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.


• Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits.


• Patient Education: Printed/online educational materials produced for people living with a particular disease or condition.


• Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

• A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event)


• A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.



13. How are programs that are jointly supported by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and another business reported?

As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organization reports programs.

14. How is the reporting period for funding determined?

All reported funding is based on Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc's financial calendar. In general, grants are reported based on financial quarters, which are 13 weeks in length. Although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

15. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

16. What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization. Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is also reporting the unused funds received from an accredited provider/educational sponsor as a lump sum in the quarter they are returned.

For the purposes of accuracy, Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is reporting the actual funds disbursed to a grant applicant and, if applicable, the educational partners as specified in the written agreement. Should the educational activity not require all of the funds originally specified in the agreement, unused funds would not be disbursed.

 

Charitable Contributions Process Statement and FAQs

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources."

 

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

 

All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

• Organizations that do not have a valid federal tax-exempt status


• Scholarships to individuals


• Direct contributions to individuals or physician practices


• Loans


• Trips or tours


• Endowments of any kind


• Sectarian and religious organizations that do not serve the general public on a nondenominational basis


• Capital requests (building funds, endowments, multi-year commitments)


• Political, fraternal or athletic groups

 

Product contributions must be used in the manner defined below:

• Product contributions will only be placed with licensed medical and health care professionals


• Product contributions cannot be transferred in exchange for money, other property or services


• Product contributions cannot be used for research, experimental, or demonstration purposes


• Product contributions cannot be billed to any third party payor (public or private)


• For purposes of disclosure and reporting, product contributions are valued at the Company's list price

Charitable Contributions FAQs
 

1. Why is charitable contribution information being disclosed?

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is proud to have the privilege of providing charitable contributions to various community organizations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.


2. What charitable contribution information is being disclosed?

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is providing the name of the requestor, the city/state where the requesting organization resides, the title of the activity, the amount of the contribution, and the type of contribution (cash or product).


3. How is the total amount of the charitable contribution determined and distributed?

The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organizational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organization has complete control over the distribution of funds received from Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.


4. What is the difference between a charitable contribution and an educational grant?

An Educational Grant falls into one of the following categories:


• Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.


• Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits.


• Patient Education: Printed/online educational materials produced for people living with a particular disease or condition.


• Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.



Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

• A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event.


• A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.



 

5. How does the company handle expenses that are part of a charitable contribution for which Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc receives some benefit?

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc requires organizations to complete an Omnibus Budget Reconciliation Act of 1993 (OBRA) form. This form documents the amount of the contribution that can truly be considered charitable versus a portion of the amount that represents payments for expenses by the organization for which Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc receives some benefit (i.e., business expenses). Please note that some of these nominal business expenses associated with some charitable contributions may be included in this report.


6. How are programs that are jointly supported by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc and another business reported?

As each company is a separate legal entity, the individual company that provides the funds directly to the requesting organization is responsible for reporting the donation.


7. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of contribution requests Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organizations submitting proposals to Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, which is determined by the requestors needs. In addition, changes in the availability of Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc funds affect the volume and dollars available for contributions.


8. How is the reporting period for funding determined?

All reported funding is based on Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc's financial calendar. In general, grants are reported based on financial quarters. Financial quarters are 13 weeks in length and, although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.


9. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

 

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance,¹ it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Several hundred to thousands of educational grant requests can be received by Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc each year. Unfortunately, not all educational grants that are submitted for consideration can be funded. Educational grant rejection rates of 50-60% are often observed.

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:

• Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient


• Accredited educational activities should be independent and without influence from commercial supporters


• Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice


• Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor


• Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional

 

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

 

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.

Each grant request submission is evaluated on four common components:

• The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap


• A proposed or final agenda and/or brochure


• A detailed budget outlining how the funds will be utilized


• A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.

Examples of reasons for denial of educational grants may include:

• Vague or incomplete grant applications


• Requests that appear to promote a medical practice or office


• Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer


• Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training


• Grants to specifically promote an individual product


• Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products


• Events that include a social activity or entertainment that overshadow the educational activity


• Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo


• All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees).


• Limited funds available in Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc's educational budget


• Recent funding of similar educational activity

Pricara^®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

More information about reporting of grants and contributions can be found at www.jnj.com.