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State Aggregate Spend Compliance Laws: Topic at Seton Hall Law Healthcare Compliance Certification Program
June 13, 2011
“Keeping an Eye on You: State Aggregate Spend and Marketing Disclosure Laws,” was the subject of a presentation on June 13 at Seton Hall Law Healthcare Compliance Certification Program. Elizabeth H. Kim, Manager, Regulatory and Compliance Services, Porzio Pharmaceutical Services, was one of the co-presenters.
The various state laws can impose up to 50 deadline dates associated with state marketing laws, presenting an onerous burden, challenge, and complex situation for drug and device companies trying to comply with a whole range of compliance laws regarding aggregate spend.
As an example, Ms. Kim pointed out, West Virginia requires companies to report “total amount spent on advertising and direct promotion of prescription drugs to consumers, prescribers, pharmacies and patient support or advocacy groups,” as well as gifts, grants or payments for the purpose of advertising prescription drugs.” Or, as another example of the complexity, in Massachusetts, she continues, regulations prohibit the provision of meals to physicians outside of an office or hospital setting. Beyond this prohibition, Massachusetts requires companies to submit a certification of compliance stating that they have adopted and trained employees on a code of conduct.
These are just a few examples of the home rule interpretation of state-specific aggregate spend compliance challenges faced by life sciences companies that Ms. Kim presented in this program.
Fortunately, Porzio Pharmaceutical Services created and maintains a database that tracks the bevy of laws in the user-friendly Porzio Compliance Digest that helps companies navigate and comply with the laws. It further includes an interactive map that a company’s personnel can use – by clicking on a state, a list of the applicable laws and regulations pops up. The Digest also provides a helpful comparison chart, “Aggregate Spend: State by State Overview.”
In addition, Porzio Pharmaceutical Services offers a robust aggregate spend compliance solution, Porzio AggregateSpendID, that provides an A-Z solution for pharmaceutical, medical device and biologics companies to deal with their aggregate spend obligation.
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