Regulatory Compliance Q&A
Currently, eight states and the District of Columbia each have unique legislation that requires pharmaceutical and medical device companies to report their expenses for gifts, marketing, advertising, and other promotional expenses to physicians, organizations, institutions, and other HCPs. These expenses also include grants, consulting fees, meetings, speaker fees, and honoraria. These requirements don’t prohibit the marketing of products to healthcare practitioners; rather, they cause pharmaceutical companies to be more transparent, and in some cases, to adhere to a code of conduct in how they interact with healthcare practitioners. Knowledge and training of applicable personnel of the different state regulations (pending and enacted) as well as guidance documents (such as PhRMA’s code of Interactions with Healthcare Professionals) will ensure that pharmaceutical companies promote their products appropriately.
Specific to disclosure, companies either struggle on the front end to ensure they collect accurate and timely data from multiple sources (because these requirements go far beyond the interaction between the sales representative and the healthcare practitioner) or on the back end, to consolidate the data for proper analysis and reporting – or both.
We have seen companies of various sizes attempt to tackle this problem manually, with spreadsheets, with multiple systems, etc. Increasingly though, pharmaceutical companies have begun to look to technology to help them manage the volumes of data that must be collected and matched against a customer master directory for validation of the prescriber/recipient’s credentials, eliminate duplicates, and ensure the accuracy of the data details or for aggregation of the total expenses for each customer. As the data is collected over the course of the year, it must be stored in a database and processed against each state’s set of regulations or business rules, and then prepared for review and submittal in the most current version of that state’s report template or format.
Those pharmaceutical companies that are in the process of leveraging flexible technology now will have an upper hand as more states enact monitoring and disclosure regulations. By leveraging technology, sales and marketing arms within a pharmaceutical company will decrease their administrative burden associated with these requirements, so that resources and time can be allocated appropriately. Furthermore, if and when federal disclosure regulations are enacted, an additional level of scrutiny will exist.