Novartis Trileptal $422.5 Million Settlement and Corporate Integrity Agreement

The Department of Justice (DOJ) announced that Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products. The company will plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for the off-label promotion of Trileptal in violation of the Food, Drug and Cosmetic Act. In addition to the criminal fine and forfeiture, Novartis has agreed to pay $237.5 million to resolve civil allegations under the False Claims Act that the company unlawfully marketed Trileptal and five other drugs, and thereby caused false claims to be submitted to government health care programs.

The civil settlement resolves four lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. As a result, the whistleblowers, all former employees of Novartis, will receive payments totaling more than $25 million from the federal share of the civil recovery.

The Food and Drug Administration (FDA) approved Trileptal as an anti-epileptic drug, for the treatment of partial seizures, but not for any psychiatric, pain or other uses. Once the FDA approves a pharmaceutical, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as “unapproved” or “off-label” uses.

Consequently, the civil settlement resolves allegations that Novartis illegally promoted Trileptal for a variety of uses, including psychiatric and pain uses, which were not medically accepted indications and therefore not covered by those programs. The agreement also resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Trileptal and five other drugs, Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The federal share of the civil settlement is $149,241,306, and the state Medicaid share of the civil settlement is $88,258,694.

In response to these developments, Andy Wyss, Head of Novartis Pharma North America and President of Novartis Pharmaceuticals Corporation noted in a press release that the company “was pleased to have reached resolution on this matter.” He added that Novartis “will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products.” Mr. Weiss continued that the company’s “goal is to ensure that patients receive the medicines they need and we will continue to work with the government and other organizations to improve healthcare for all Americans.”

Corporate Integrity Agreement

Novartis also entered into a five year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG), which a number of programs and establishes policies and procedures. The CIA is very similar to the one recently agreed to with Forest Laboratories.

The CIA requires that policies be in place regarding programs to educate sales representatives, including but not limited to mentorships, preceptorships, or presentations by health care providers (HCPs) at sales meetings and experience-based learning activities. In addition, Novartis must design policies that comply with all applicable Federal health care program and FDA requirements for:

· Sponsorship

· Employee training

· Samples

· Authorship

· Promotional materials; and

· Funding of grants (including educational grants) or charitable contributions

Novarits must also have policies in place that comply with HHS and FDA regulations regarding consultant or other fee-for-service arrangements entered into with HCPs or HCls (including, but not limited to speaker programs, speaker training programs, presentations, consultant task force meetings, advisory boards, and ad hoc advisory activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements. With respect to educational grants specifically, the CIA require that:

· Novartis disclose its financial support of the Third Party Educational Activity and, any financial relationships with faculty, speakers, or organizers at such Activity;

· The third party agrees to disclose Novartis’s financial support of the Third Party Educational Activity and any financial relationships that Novartis might have with faculty, speakers, or organizers at such Activity;

· Any faculty, speakers, or organizers at the Third Party Educational Activity agree to disclose any financial relationship with Novartis;

· The Third Party Educational Activity have an educational focus;

· The content, organization, and operation of the Third Party Educational Activity be independent of Novartis control;

· Novartis support only Third Party Educational Activity that is non-promotional in tone/nature; and

· Novartis support of a Third Party Educational Activity is contingent on the provider’s commitment to provide information at the Educational Activity that is fair, balanced, accurate and not misleading;  

 

Field Force Monitoring Program (FFMP)

The Field Force Monitoring Program (FFMP) is designed to evaluate and monitor various aspects of Novartis’s interactions with HCPs and HCIs, including interactions between sales representatives and HCPs and HCIs. The FFMP includes:

1)    Speaker Monitoring Program;

2)    Direct field observations (Observations) of sales representatives;

3)    The monitoring and review of other records relating to sales representatives’ interactions with HCPs and HCIs (Records Reviews).

Speakers will be required to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use Novartis-approved materials and may not directly or indirectly promote the product for off-label uses.) Speakers will be paid according to a centrally managed pre-set rate structure determined based on a fair-market value analysis conducted by Novartis.

The Speaker Monitoring Program requires the attendance at 125 speaker programs relating to Government Reimbursed Products during each Reporting Period and conduct live audits of those programs (Speaker Program Audits). Novartis compliance personnel or other appropriately trained Novartis personnel who are independent from the functional area being monitored or outside personnel acting on behalf of Novartis will evaluate these programs. For each program reviewed, personnel conducting the Speaker Program Audits will review:

· Slide materials and other materials used as part of the speaker program,

· Speaker statements made during the program, and

· Novartis representative activities during the program to assess whether the programs were conducted in a manner consistent with Novartis’s Policies and Procedures.

 Direct field observations of sales representatives will also be done to assess whether the messages delivered and materials distributed to HCPs are consistent with Novartis’ Policies and Procedures.

These Observations will be full day ride-alongs with sales representatives, and each Observation will consist of directly observing all meetings between a sales representative and HCPs and other representatives of HCIs during the workday. There will be at least 50 full-day Observations during each Reporting Period. The Novartis compliance personnel or other appropriately trained individuals will report from these observations a number of things such as the name of the sales representative, the date, and the overall assessment of compliance with Novartis policy.

In addition, there will also be records review relating to the activities of a sampling of sales representatives in each region associated with the promotion of at least three Government Reimbursed products. Records Reviews will include the monitoring and review of selected:

Records and systems relating to sales representatives’ interactions with HCPs and HCIs relating to promotional speaker program activities, samples, meals, and other events or items

Requests for medical information through the MIC Department;

· Preceptorships;

· Message recall studies or other similar records (such as Verbatims) purporting to reflect the details of sales representatives’ interactions with HCPs and HCIs;

· Sales representatives’ e-mails and other electronic records; and

· Recorded results of the Observations, if any, of the sales representatives and applicable notes or information from the sales representatives’ managers.

Non-Promotional Monitoring Program

All researchers, authors, and consultants must enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the individual. They will be paid according to a centrally managed, rate structure which incorporates appropriate objective criteria and is determined based on a fair-market value analysis conducted by Novarits. Accordingly, the program will monitor:

· At least 50 Consultant arrangements with HCPs

· At least 20 Researcher arrangements with HCPs or HCIs (20 IITs and at least 10 other post-marketing Researcher arrangements.) and

· At least 25 publication activities will be monitored.

Consulting

For consultant arrangements, the following will be reviewed:

· The business purpose/necessity of the engagement including the broader context of other approved events (i.e., a needs assessment);

· The general qualifications and experience of the consultant to provide the service;

· The number of consultants necessary for the event;

· Venue/location (as applicable);

· Payment and anticipated expenses; and

· Compliance with other applicable legal standards

Additionally, in order to assess whether the programs and arrangements were conducted in a manner consistent with Novartis’ Policies and Procedures, audits of consultant arrangements will review:

· Needs assessment documents

· Consultant contracts; and

· Materials relating to the program or work of the Consultant (including work product resulting from any program or event)

Research

Novartis is required to establish a process to ensure that a needs assessment has been completed to justify the retention of the Researcher prior to the retention of the Researcher. The needs assessment must identify:

· The business or scientific need for the information

· Information about the numbers and qualifications of the HCPs/HCls to be engaged

· A description of the proposed research (including the research protocol); and

· Type of work product to be generated.

· Audits of researcher activities will look at needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments.

Publications

Novartis is required to establish a process to ensure that needs assessment provide information about Publication Activities to be performed (including a description of the proposed work to be done, type of work product to be generated, and the purpose for the work. This includes a requirement that all authors of biomedical manuscripts fully comply with the International Committee of Medical Journal Editors (ICMJE) criteria regarding authorship and disclosure of their relationship with Novartis, and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work.

Medical Education Grants

All medical education grants are processed through the Novartis Office of Grants and Education (NOGE) and the Novartis Oncology Office of Grants (OGE). All medical education grant requests received by Novartis are evaluated by individual(s) independent of Sales and Marketing. Novartis policy expressly prohibits the involvement of Sales and Marketing personnel in the medical education grant decision-making process. The company asserts that Sales and Marketing have no involvement in, or influence over, the review and approval of medical education grants. During the course of the CIA, Novartis will continue to follow this process or must notify the OIG in writing at least 60 days prior to the implementation of any new system subsequent to the Effective Date.

The Grant Monitoring Program will review at least 30 medical education grants. Novartis personnel conducting the Grant Monitoring Program will review:

· Proposal documents (including grant requests)

· Approval documents

· Contracts

· Payments and materials relating to the review of the requests, and

· Documents and materials relating to the grants and any events or activities funded through the grants

Reporting of Physician Payments

On or before March 31, 2011, Novartis must post in a prominent position on its website an easily accessible and readily searchable listing of all U.S.-based physicians who received Phase I Payments directly or indirectly from Novartis during the fourth quarter of 2010 and the aggregate value of such Payments. Phase I Payments are defined as:

· Payments, fees, honoraria, or compensation made by Novartis directly or indirectly in connection with

· Promotional speaker programs and promotional speaker training to a physician

· In return for contracted services for Novartis to be performed expressly by the physician, with the exception of trips or travel, educational items, and meals (which are not otherwise covered or paid for by the Physician).

After reporting begins, 60 days after the end of each calendar quarter, up to and including the third quarter of 2011, Novartis must post on its website a report of the cumulative value of the Phase I Payments provided to each physician during the preceding calendar quarter.

On or before March 1, 2012, Phase II reporting begins, which include posting all other “payments or transfers of value” as defined in the Affordable Care Act. Phase II payments also include those made to Related Entities, and any payments or transfers of value made, directly by Novartis or by a vendor retained by Novartis to a physician or

Related Entity in connection with, or under the auspices of, a co-promotion. Phase III payments are pretty much the same as Phase II and reporting of those begins on March 1, 2013, with the same requirement of posting payments 60 days after the end of each calendar quarter.

The listing such payments must include a complete list of all individual physicians and Related Entities to whom or to which Novartis directly or indirectly made Payments in the preceding calendar quarter(s) or year (as applicable). The listing will be arranged alphabetically according to the physicians’ last name or the name of the Related Entity. For each physician or related entity, the listing will include:

Physician’s full name;

· Name of Related Entity (if applicable);

· City and state of the physician’s practice or the Related Entity;

· The purpose of the payment(s); and

· The aggregate value of the payment(s) in the preceding quarter(s) or year (as applicable).

Beginning on February 28, 2011, Novartis will also post in a prominent position on its company website on an annual basis throughout the term of the CIA the following information regarding both medical education grants and charitable contributions:

· The ultimate recipient organization’s name, to the extent known by Novartis;

· A brief description of the program for which the grant or charitable contribution was requested; and

· The amount of the grant or charitable contribution.

Phase I reporting begins on February 28, 2012, in which Novartis must post information about medical education grants and charitable contributions processed through Novartis’ Grant Central Station (GCS) provided to healthcare related organizations, during the calendar year 2011. Grants include continuing medical education (“CME”) and non-CME funding requests, and charitable contributions include funding to a healthcare related charitable organization in which the contribution’s purpose is:

· Related to patient disease state education;

· To provide health screening; or

· To improve patient access to treatment.

Phase II reporting beings August 30, 2012, in which Novartis must post in a prominent position on its website a listing of information about Phase I Payments described above, plus additional medical education grants and charitable contributions provided to health care related organizations processed through other payment mechanisms beyond GCS for the first two quarters of 2012. Additional payments include:

Certain Philanthropic Grants, such as funding educational initiatives involving community initiatives and health awareness programs;

Fundraising Contributions intended to provide support to the mission and activities of a non-profit, tax exempt organization;

Dues provided to a non-profit group or organization for patient advocacy, professional societies or advisory panels to the organization; and

Sponsorships provided to a non-profit, tax exempt organizations to enable the organization to continue its mission and activities for an entire organization or for a specific event.

Thereafter, 60 days after the end of each calendar year, Novartis must post on its website a report of the value of Phase II Payments provided to each healthcare related organization, as defined above, during the preceding calendar year for the term of this agreement.

Novartis must also submit an annual report to HHS OIG containing data and information with respect to all of the promotional and non-promotional monitoring programs, as well as other policy and procedure matters pertaining to the CIA.

Documents

Novartis Corporate Integrity Agreement

Novartis Settlement Agreement

Department of Justice Press Release

Novartis Press Release