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PROFESSIONAL CONDUCT COMPREHENSIVE COMPLIANCE

 

Mayer Laboratories Professional Conduct Comprehensive Compliance Program Pursuant to California Health and Safety Code §§ 119400 – 119402

The California Health and Safety Code §§ 119400 – 119402 (the "California Law") requires that "pharmaceutical companies" (including certain medical device companies) adopt a Comprehensive Compliance Program that (i) is in accordance with the Office of Inspector General's 2003 Compliance Program Guidance for Pharmaceutical Manufacturers (the "OIG Guidance"); (ii) includes policies for compliance with the "Code on Interactions with Healthcare Professionals" published by the Pharmaceutical Research and Manufacturers of America (the "PhRMA Code"); and (iii) establishes limitations on spending on gifts, entertainment, promotional materials or other incentives given to "medical or health professionals" in accordance with the OIG Guidance and the PhRMA Code. "Medical or health professionals" is defined by the California Law to include anyone who: 1) is licensed by State law to prescribe drugs for human patients; 2) is a medical student; or 3) is a member of any drug formulary committee.

As the declaration of purpose in the preamble to the California Law indicates, the Legislature was seeking to achieve the goals expressed in the PhRMA Code and the OIG Guidance, which principally relate to controlling the marketing practices of pharmaceutical manufacturers. Mayer Labs has historically followed these principles, and now has articulated its practice.

Click here for a pdf of Mayer Labs’ Professional Conduct Comprehensive Compliance Program.

   

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