Increased Evolution of Regulations Affecting the Pharmaceutical Law Practice
Jean Frydman, US General Counsel & Chief Compliance Officer, Ferring, USA
The increase of regulations over the last two to five years for pharmaceutical companies has become a nightmare for sales representatives working for those companies and for internal staff charged with assuring the companies’ employees are following the most recent regulations affecting their actions every work day.
One area where there has been an increase of regulations is state reports. Currently, pharmaceutical companies are reporting various payments or exchanges of financial value to physicians, healthcare providers (HCPs) and affiliated healthcare organization (HCOs) to meet the complex state specific filing requirements of 6 states and Washington DC. Since 2006, 20 states have introduced legislation requiring pharmaceuticals companies to make these disclosures and it is anticipated that more states will require the reporting. The current state reporting requirements are neither consistent from state to state and can be broadly interpreted regarding the definitions of reportable entities and/or the type of transactions to be reported. The current state reporting requirements include:
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