Recognizing the need to bolster compliance activities in an era of increasing governmental scrutiny, the nation's largest medical device companies have proactively embraced a code of ethics with nearly universal adoption of standards to combat fraud and abuse of sales and marketing practices, according to a PricewaterhouseCoopers survey released recently at the Medical Device Regulatory Compliance Congress, held on the campus of Harvard University.
The survey was conducted by PricewaterhouseCoopers, in conjunction with the law firm King & Spalding LLP, and with the assistance of Nancy Singer, principal with Compliance-Alliance, which specializes in professional development for those employed in the drug and medical device industries.
The survey benchmarked how large medical device companies are complying with fraud and abuse laws since introduction of the Code of Ethics on Interactions with Healthcare Professionals in 2004. The voluntary code was developed by Advanced Medical Technology Association (AdvaMed), a trade group that represents more than 1100 medical technology companies.
'We are impressed that medical device firms have embraced standards to govern the way they interact with hospitals, physicians, researchers and other health professionals,' said John Bentivoglio, partner and co-chair FDA/Healthcare Group, King & Spalding. 'The question is whether the depth of their risk and control activities is sufficient, and whether they have considered the total relationship a medical device company has with its customer, which can be difficult across a large enterprise,' said Bentivoglio. 'The good news is that the survey demonstrates companies are developing innovative strategies to address these challenges.'