Drug industry should revisit compliance in choppy regulatory seas
His comments coincide with the launch of TGaS’ revamped commercial compliance benchmark (CCB) service, which is designed to help pharma and biotech firms understand and comply with US drug laws.
McWalters told Outsourcing-pharma that the last few years has seen greater regulatory scrutiny placed on the ways that pharma and biotech companies interact with healthcare professionals.
He added: "These trends can be seen in new laws and pending bills at the State level, that address promotional spending limits, public disclosure requirements, as well as educational requirements of sales personnel who detail drug products to physicians.”
McWalters cited the recent adoption of the PhRMA code, designed to more strictly govern the drug industry’s promotional spending, as a further example of the changes that are emerging.
He added that “Since we see this trend continuing, the industry must revisit how it interacts with healthcare professionals, and review traditional programs that may include grants, contracts, promotional items, meals, drug sampling, etc."
Robert Melillo, an industry veteran and founder of InVentiv Health’s compliance unit Pharmaceutical Resource Solutions, who will lead TGaS’ CCB team, said that: “Pharma companies face daunting compliance challenges that directly impact marketing priorities and the allocation of resources."
TGaS said that the CCB, which will examine more than 400 operational elements using the firm’s Navigator methodology, will provide clients with a more informed approach to compliance in the current regulatory environment and help them make better resource allocation decisions.
While the company could not disclosed details of drug industry clients that use its service for reasons of confidentiality, McWalter’s stressed that nine of the top 10 US pharmaceutical firms are on its books.
Melillo went on to say that: "We believe the Commercial Compliance Benchmark will give TGaS Advisors clients what they need to cost effectively develop and maintain the best possible compliance practices."
Stephen Gerard, TGaS’ managing director Advisors said that the firm's 2009 Annual State of Pharmaceutical Commercial Operations forecast predicted that compliance to be one of the areas of greatest change for the coming year.
Gerard added that: "The new benchmark will give clients a thorough understanding of the dynamic regulatory climate and a way to evaluate their own compliance status internally and against their industry peers."
