The Department of Justice (DOJ) announced that drug maker Forest Laboratories, Inc. has pleading guilty to resolve criminal charges and false claims act allegations. The pharmaceutical manufacture will be paying more than $313 million to resolve criminal and civil liability arising from these matters. This includes a $150 million criminal fine, forfeiture of $14 million in assets, and over $149 million to resolve allegations under the False Claims Act. As part of the resolution, the private whistleblowers will receive approximately $14 million from the $313 million total.
The charges stem from incidents related to obstruction of justice, the distribution of Levothroid, which at the time was an unapproved new drug, and the illegal promotion of Celexa for use in treating children and adolescents suffering from depression. The agreement also settles pending False Claims Act allegations that Forest caused false claims to be submitted to federal health care programs for the drugs Levothroid, Celexa, and Lexapro.
The company has plead guilty to one criminal felony count of obstructing justice, one criminal misdemeanor count of distributing an unapproved drug in interstate commerce, and one criminal misdemeanor count of distributing a misbranded drug in interstate commerce. Forest Laboratories has also signed a five year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG).
Corporate Integrity Agreement: Policies and Procedures
The CIA establishes policies and procedures regarding the development, implementation, and review of call panels for sales representatives who promote Government Reimbursed Products, as well as plans for the distribution of samples of Forest’s Government Reimbursed Products.
It also ensures that policies and procedures regarding consultant or other fee-for-service arrangements, entered into with health care professionals (HCPs) or health care institutions (HCIs), are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements. The policies must also include requirements about the content and circumstances of such arrangements and events. Such polices apply to, but are not limited to speaker programs, speaker training programs, presentations, consultant 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.
Similar policies must be in place regarding programs to educate sales representatives, including but not limited to mentorships, preceptorships, or presentations by HCPs at sales meetings and experience-based learning activities.
Education
Forest must design policies for sponsorship or funding of grants (including educational grants) or charitable contributions that complies with all applicable Federal health care program and FDA requirements. The policies require that:
Forest 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 Forest’s financial support of the Third Party Educational Activity and any financial relationships that Forest 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 Forest;
The Third Party Educational Activity have an educational focus;
The content, organization, and operation of the Third Party Educational Activity be independent of Forest control;
Forest support only Third Party Educational Activity that is non-promotional in tone/nature; and
Forest 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;
Policies and procedures must also ensure that review committees must review all promotional materials prior to the distribution or use of such materials for information related to Government Reimbursement Products intended to be disseminated outside Forest.
Clinical Studies
Policies must also be in place regarding sponsorship of post-marketing clinical studies or other post-marketing studies, including investigator-initiated trials (IITs), relating to Government Reimbursed Products, including:
The decision to provide financial or other support for the IITs;
The manner in which such support is provided; and
Support for publication of information about the IITs, including the publication of information about the trial outcomes and results and the uses made of publications relating to IITs;
Policies must be designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in improper promotion, sales, and marketing of Forest’s products.
Field Force Monitoring Program (FFMP)
The Field Force Monitoring Program (FFMP) is designed to evaluate and monitor various aspects of Forest’s interactions with HCPs and HCIs, including interactions between sales representatives and HCPs and HCIs. The FFMP includes: 1) a Speaker Monitoring Program; 2) direct field observations (Observations) of sales representatives; and 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 Forest-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 Forest.
The Speaker Monitoring Program requires the attendance at 175 speaker programs relating to Government Reimbursed Products during each Reporting Period and conduct live audits of those programs (Speaker Program Audits). Sixty percent of the programs subject to the Speaker Program Audits shall be in-office programs and forty percent shall be out-of-office 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 Forest representative activities during the program to assess whether the programs were conducted in a manner consistent with Forest’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 Forest’s 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 40 full-day Observations during each Reporting Period.
Sales
There will also be records review relating to the activities of a sampling of sales representatives in each region who promoted one or more of the products under review. 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 Forest. Accordingly, the program will monitor:
30 Consultant arrangements with HCPs (10 advisory board programs and 20 other professional services agreements with HCPs.)
30 Researcher arrangements with HCPs or HCIs (20 IITs and at least 10 other post-marketing Researcher arrangements.) and
At least 30 publication activities will be monitored.
Medical Education Grants Monitoring
Forest has established an office within its Compliance Department as the exclusive mechanism for awarding industry support of independent medical education activities, sponsorships, funding for awareness and advocacy programs and other industry support. Forest represents that its Sales and Marketing departments have no involvement in, or influence over, the review and approval of medical education grants.
All funding requests for industry support are submitted through an on-line process (known as FRXIS) and requests are processed in accordance with standardized criteria developed by the Medical Affairs Department. Forest will continue the FRXIS process described above (or an equivalent process) throughout the term of the CIA, and 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 medical education grants, sponsorships, advocacy/awareness grants and other support on a pro rata basis according to the number of such programs. There will be audits of at least 30 medical education grants and other types of industry support for each Reporting Period. Forest 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 Payments to Physicians and Healthcare Organizations
By January 1, 2011, Forest will begin Phase I Reporting by posting in a prominent position on its website an easily accessible and readily searchable listing of all U.S.-based physicians and Related Entities who or which received any Phase I Payments directly or indirectly from Forest during the first three calendar quarters of 2010. Phase I payments include payments or transfers of value (whether in cash or in kind) made to physicians and/or to Related Entities in connection with:
Medical education grants,
Awareness and advocacy initiatives,
Sponsorships, and
Contributions or general support of an organization.
After the initial posting, 60 days after the end of each subsequent calendar quarter, Forest must also post on its website a listing of updated information about all Phase I Payments made during the preceding calendar quarter. On March 1 of each calendar year, Forest will also post on its website a report of the cumulative value of Phase I Payments provided to each physician and/or Related Entity during the preceding calendar year.
Phase II payments include all Phase I Payments (as defined above) and all other “payments or transfers of value” as defined in the Affordable Care Act. Phase II reporting will terminate the obligations of Phase I reporting, and will begin by May 1, 2012. No later than March 1, 2013, Forest will also post on its website a report of the cumulative value of Phase II Payments provided to each physician and/or Related Entity during the preceding calendar year. Thereafter, on or before March 1 of each subsequent year, Forest will post a report on the cumulative value of Phase II Payments provided to each physician and/or Related Entity during the preceding calendar year.
The listing such payments must include a complete list of all individual physicians and Related Entities to whom or to which Forest 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:
· Payment amounts in $10,000 increments or in the actual amount paid;
· 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).
By January 1, 2011, and updated each quarter during the term of the CIA, Forest will post on its company website the following information with respect to medical education grants and other industry support:
· The recipient organization’s name:
· A brief description of the program the grant/support was requested for; and
· The amount of the grant or contribution.
Authorship and Publications
Forest expects 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 Forest and to disclose any potential conflicts of interest, including any financial or personal relationships that might be perceived to bias their work.
This includes an explicit requirement from Forest that Authors disclose in their manuscripts, journal submissions, and elsewhere as appropriate or required, any potential conflicts of interest, including their financial or personal relationship with
Forest, the names of any individuals who have provided editorial support for any manuscript or other publication, and all funding sources for the study or publication.
Summary
Overall this settlement and CIA is similar to many of the recently settled cases which all include a significant monitoring element, and rules on publications. As far as continuing medical education is concerned compliance to the ACCME standards of commercial support and close attention to ensure that the program is fair balanced should meet the government standards.