Merck Medical educational grants

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.

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”).

CME Presentation
Springer Guide to Effective Grant Writing: How to Write a Successful NIH Grant Application
Book (Springer)
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