Pharmaceutical Commerce - July/August 2011 - (Page 31)

Legal Regulatory < continued from page 29 and device companies when they enacted these marketing disclosure laws,” says Kyle Sampson of Hunton & Williams. “Pulling together the information that these laws require really has been a monumental and expensive undertaking for many companies. And the shifting legal requirements, year after year, have not made it any easier.” PPACA requires that the transactions between HCPs and manufacturers be published on a searchable government website by September 30, 2013, and gives HCPs right to review (and either validate or dispute) all value transactions that will be publicly disclosed about them before the official report is sent to the government. Toward that end, “many companies and technology firms are attempting to be proactive and design online portals with routing and review functionality so that inquiries can be quickly and easily routed, reviewed, reconciled and in certain instances set for adjustments and resubmissions of data,” says Carmel of Polaris. “It’s a good idea to give HCPs a chance to review charges attributed to them before the data are reported to the government and published for the general public,” says Johngren of Parallax. “Nothing is served by having misleading information posted and then retracted or corrected after it has already done its damage with the physician and his or her patients or peers.” Commercial analytics When state-level agg spend compliance reporting was first mandated, many in the legal and compliance communities felt this information should be used for compliance reporting only. However, many observers believe that beyond compliance, a welldesigned approach to managing enterprisewide agg spend activities also has the potential to support other strategic objectives. “As companies prepare for Sunshine, we hear more of them asking the question ‘What can we learn from these data?’” says D’Urso of Knowledgent. “We are seeing many companies reevaluating their approaches to spend compliance reporting, and taking real steps toward using this information to gain competitive advantage in other areas.” “Companies are surprised at how little they actually know about their interactions and spend with HCPs and HCOs. As a result, they will be able to make better decisions on how and where they allocate their spend,” says Carmel of Polaris. “This is apparent even within larger companies that tend to have well-developed processes and systems, and it is vividly apparent in the R&D space, showing how compartmentalized that portion of the organization can be.” Others note that better agg spend data transparency also tends to highlight the lack of comprehensive awareness of HCP/HCO utilization across different areas of the business, and differing payments made for similar activities across the enterprise. “The greater transparency, and increased granularity of data collected by recipient and by spend activity should allow life sciences companies to run a focused ROI analysis allowing for more targeted allocation of resources in the future,” adds Burgess of Ernst & Young. However, at this point, many industry observers agree that the potential goals seem to be more aspirational than actual, and there are risks in damaging relationships with key opinion leaders, and others, by driving the analysis too heavily in the direction of ROI. While the state and federal Sunshine laws aim to bring greater transparency to the financial transactions between life sciences companies and HCPs and HCOs, the resulting disclosures will inevitably invite questions from the public and from the media, and criticism from those looking to expose impropriety. “Such a transparent, online system that is publicly accessible will inevitably be mined for pattern of payments to doctors that can then be mischaracterized or worse,” says attorney Sampson. “Companies will have to be ready for this.” Experts agree that communications and public relations plans should be developed to reinforce the benefits of legitimate interactions between the industry and HCPs/HCOs. PC July | August 2011 31 www.PharmaceuticalCommerce.com http://www.valuecentric.com http://www.valuecentric.com http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011
Contents
Op-Ed
Top News
Business/Finance
Brand Communications
Supply Chain/Logistics
Manufacturing & Packaging
Legal/Regulatory
Information Technology
PDMA Exhibitors
Meetings and Editorial Index

Pharmaceutical Commerce - July/August 2011

Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover1)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page Cover2)
Pharmaceutical Commerce - July/August 2011 - Pharmaceutical Commerce - July/August 2011 (Page 3)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 4)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 5)
Pharmaceutical Commerce - July/August 2011 - Contents (Page 6)
Pharmaceutical Commerce - July/August 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 8)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 9)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 10)
Pharmaceutical Commerce - July/August 2011 - Top News (Page 11)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 12)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 13)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 14)
Pharmaceutical Commerce - July/August 2011 - Business/Finance (Page 15)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 16)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 17)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 18)
Pharmaceutical Commerce - July/August 2011 - Brand Communications (Page 19)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 20)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 21)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 22)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 23)
Pharmaceutical Commerce - July/August 2011 - Supply Chain/Logistics (Page 24)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 25)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 26)
Pharmaceutical Commerce - July/August 2011 - Manufacturing & Packaging (Page 27)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 28)
Pharmaceutical Commerce - July/August 2011 - Legal/Regulatory (Page 29)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 30)
Pharmaceutical Commerce - July/August 2011 - Information Technology (Page 31)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 32)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 33)
Pharmaceutical Commerce - July/August 2011 - PDMA Exhibitors (Page 34)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page 35)
Pharmaceutical Commerce - July/August 2011 - Meetings and Editorial Index (Page Cover4)
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