Regulating CME: States Attorney’s Join in the Act

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The States Attorney Generals have joined in the act of regulating CME.

On May 20th, Merck settled with States Attorney Generals on Vioxx litigation.  As part of the settlement, Merck agreed to restrictions on a variety of topics that include promotional claims, DTC advertising, drug safety monitoring boards, manuscript authorship, clinical trial posting, and CME.

For CME Merck Agreed to Three things:

A)   Merck shall comply with ACCME Standards for Commercial Support:

Merck will include in their promotional speaker contracts a pledge that if the speaker has worked for or received compensation from Merck in the therapeutic category the program concerns in the last 12 months, the speakers will:

Disclose to participants orally and to the CME provider for inclusion in the written materials:

                                                  i.    The existence

                                                ii.    Nature

                                               iii.    Purpose of their arrangement with Merck

                                               iv.    Type of promotional work engaged

B)   Merck shall not fund a CME program if at the time of funding decision they had knowledge that a speaker had also been a promotional speaker in the last 12 months at a Merck-sponsored promotional event related to the class of drugs to be discussed in the activity.

C)   The agreement in respect for CME:

a.    Shall remain in effect for 9 years.

b.    Shall only apply to speakers’ contracts entered into, amended to extend the contract period, or renewed after the date of this Agreement.

The attorney generals understand that disclosure is important.

As CME funders and providers strive to eliminate and reconcile conflicts of interest, it is important to remember that we are under tremendous scrutiny and must work to do an excellent job at this piece of the puzzle.

Press the link for copies of the Download merck settlement may 20 2008 cme section full settlement and analysis.

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