Companies Face 'Significant Challenges' Implementing AdvaMed Marketing Code

Medical device companies "overwhelmingly" accept AdvaMed's Code of Ethics on Interactions with Health Care Professionals, but they face "significant challenges" in implementing the code, according to a white paper released last week.

The paper, released by PricewaterhouseCoopers, King & Spalding and Compliance-Alliance, is based on a survey the firms conducted in January.

Seventy-two medical device officials completed the survey. The results showed three main obstacles to more widespread adoption of the code.

The first is a lack of clear regulatory guidance on what sales and marketing practices are unlawful. The second is a lack of awareness or acceptance by physicians and other customers that old business practices may no longer be allowed. Third is insufficient recognition by top company management of the resources required for implementing the code.

Survey respondents offered examples of areas where regulatory guidance would be useful, including: The appropriate circumstances for bundling goods and/or services; When free goods may be provided; The appropriate use of data from postmarket studies without violating off-label promotion rules; A better definition of what constitutes unlawful marketing activities for in vitro diagnostic devices; and A method for determining whether a gift or payment is "reasonable."

More guidance from regulatory agencies is unlikely to be available soon or be sufficiently detailed, the paper said.

AdvaMed's Code of Ethics can be accessed at: www.advamed.org/publicdocs/coe.html ( http://www.advamed.org/publicdocs/coe.html ).

( http://www.fdanews.com/ddl/34_14/ )