Merck Vioxx Corporate Integrity Agreement and Continuing Medical Education Grants
Recently Merck agreed to pay $950 million and pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx, according to announcements from the company and the Department of Justice.
As noted by the New York Times, Merck agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce.
The charge arose from Merck’s promotion of Vioxx to treat rheumatoid arthritis before the Food and Drug Administration approved it for that purpose in 2002.
Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. Those payments will settle civil claims that its illegal marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed.
By the time Vioxx, which was approved by the Food and Drug Administration in 1999, was pulled off the market in 2004 because evidence showed that it posed a substantial heart risk, about 25 million Americans had taken the drug. Merck, based in Whitehouse Station, N.J., withdrew Vioxx from the market in more than 80 countries in 2004 after a clinical trial showed it doubled the risk of heart attack, stroke and death.
In a statement, Merck said that it had previously disclosed the seven-year investigation by the United States attorney in Massachusetts and had charged $950 million against its earnings in October 2010. Consequently, the Department of Health and Human Services (HHS), Office of the Inspector General (OIG), recently posted the Corporate Integrity Agreement (CIA) Merck has entered into. Below are the relevant provisions dealing with continuing medical education (CME) programs and activities.
Prior to the Effective Date of this CIA, Merck established a voluntary compliance program applicable to all Merck employees (Compliance Program). Merck’s Compliance Program includes a Vice-President, U.S. Business Practices and Compliance/Global Support (who is the Compliance Officer for Global Human Health – U.S. Markets (GHH-U.S.), Merck Vaccines (MV) and the Global Commercial Support Organizations (GCSO)) (referred to as the “Compliance Officer”).
Merck also established the U.S. Business Practices and Compliance/Global Support group (BP&C) that works in conjunction with the head of Merck’s Office of Ethics (Ethics Officer). The Compliance Program also includes a Code of Conduct, written policies and procedures, educational and training initiatives, a Disclosure Program that allows for the confidential disclosure and investigation of potential compliance violations and appropriate disciplinary procedures, screening measures for Ineligible Persons, and regular internal auditing procedures.
In 2010, Merck entered a Unified CIA with the OIG, however this CIA supersedes and replaces the Unified CIA.
Merck is required to continue its Compliance Program throughout the term of this CIA. Merck may modify its Compliance Program as appropriate, but, at a minimum, Merck must ensure that during the term of this CIA, it complies with all obligations in the CIA.
Merck 2011 Corporate Integrity Agreement
The CIA defines “Third Party Educational Activity” as “any scientific, educational, or professional program, meeting, or event conducted by a Third Party and supported by Merck, including but not limited to continuing medical education (CME), disease awareness, or sponsorship of symposia at medical conferences.”
To the extent not already accomplished, within 120 days after the Effective Date, the CIA requires Merck to develop and implement a monitoring program for medical education grants, referred toas the Non-Promotional Monitoring Program.
Medical Education Grant Activities. In agreeing to the CIA, Merck represented that it has established a grants office within its GMA Department as the exclusive mechanism through which requestors may seek or be awarded grants for independent medical education activities funded by GHH-U.S.
Merck also represented that it has established a grants committee within MV as the exclusive mechanism through which requestors may seek grants for independent medical education activities funded by MV.
Merck represented that its sales and marketing departments have no involvement in, or influence over, the review and approval of U.S. medical education grants. Merck noted that grant requests must be submitted through an on-line process and requests are processed in accordance with standardized criteria developed by the grants office. Merck agreed to continue the medical education grant process described above (or an equivalent process) throughout the term of the CIA, and would notify the OIG in writing at least 60 days prior to the implementation of any new system subsequent to the Effective Date.
To the extent not already accomplished, within 120 days after the Effective Date, Merck must establish a Grants Monitoring Program through which it must conduct audits for each Reporting Period of at least 30 medical education grants funded by GHH-US or MV.
The Grants Monitoring Program must select grants for review both on a risk-based targeting approach and on a sampling approach. Merck U.S. compliance personnel or other appropriately trained Merck personnel conducting the Grants Monitoring Program must review proposal documents (including grant requests), approval documents, contracts, payments and materials relating to the grant office’s review of the requests, and documents and materials relating to the grants and any events or activities funded through the grants in order to assess whether the activities were conducted in a manner consistent with Merck’s Policies and Guidance Documents. Results from the Grant Monitoring Programs, including the identification of potential violations of policies, will be compiled and reported to the U.S. Compliance Department for review and follow-up as appropriate.
Reporting of Merck CE Grants
The CIA requires Merck to have in place written policies and guidelines regarding the sponsorship or funding of grants (including educational grants) or charitable contributions, as well as any Third Party Educational Activity.
These Policies and Guidance Documents must be designed to ensure that Merck’s funding and/or sponsorship complies with all applicable Federal health care program and FDA requirements. The Policies and Guidance Documents must require that:
- Merck disclose its financial support of the Third Party Educational Activity and any financial relationships with faculty, speakers, or organizers at such Activity;
- as a condition of funding, the third party shall agree to disclose Merck’s financial support of the Third Party Educational Activity and to require faculty, speakers, or organizers at such Activity to disclose any financial relationship with Merck;
- the Third Party Educational Activity has an educational focus;
- the content, organization, and operation of the Third Party Educational Activity be independent of Merck’s control;
- Merck support only Third Party Educational Activity that is non-promotional in tone/nature; and
- Merck’s support of a Third Party Educational Activity shall be contingent on the provider’s commitment to provide information at the Third Party Educational Activity that is fair, balanced, accurate and not misleading.