|Survey: Medtech Companies Meeting Challenge of Ethics Standards|
Results of a recent survey indicate that while medical device companies are making progress toward compliance with industry standards for sales and marketing ethics, they are also continuing to encounter challenges along the way.
The new survey is a follow-up to a 2006 survey among medical device companies that revealed overwhelming acceptance of industry's Code of Ethics on Interactions with Health Care Professionals. Industry association AdvaMed developed the code in 2003 in order to promote a high standard of ethical conduct by companies in the medical technology industry.
The 2007 survey benchmarks the code's effect on firms' internal operations and the challenges that medical device companies face in fully complying with the code's standards. The survey was conducted by PricewaterhouseCoopers LLP (New York City) in conjunction with the law firm of King & Spalding LLP (Washington, DC) and Compliance-Alliance LLC (Arlington, VA). Results of the survey were presented at the Medical Device Regulatory, Reimbursement, and Compliance Congress, held on the campus of Harvard University at the end of March. Highlights of the survey results included the following.
Respondents cited several specific challenges to implementing a comprehensive compliance program, including the following.
"The results of this survey demonstrate that device companies should pursue a two-track compliance strategy," said John T. Bentivoglio, cochair of King & Spalding's FDA and healthcare group. "Companies should work with AdvaMed and others to secure additional guidance from key regulatory agencies, while moving ahead on their own to address emerging sales and marketing risk areas, including educational and research funding, reimbursement support, and off-label promotion."