 William E. Buzzeo Cegedim Dendrite Vice President and General Manager Visit Website |
Bill Buzzeo is a leading authority on regulatory requirements facing today’s pharmaceutical industry, specifically those involving the Prescription Drug Marketing Act (PDMA), the Controlled Substances Act (CSA), and state regulatory requirements. For the past 10 years, Bill has worked with pharmaceutical companies to mitigate their compliance risk, remediate potential violations and stay ahead of the changing regulatory landscape.
Before joining BuzzeoPDMA in July 1999, which Cegedim Dendrite acquired in 2005, Mr. Buzzeo spent seven years with Knoll Pharmaceuticals, where he worked in a variety of capacities such as sales, sales management, and sales operations.
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Regulatory Compliance Q&A
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As states institute stricter pharmaceutical marketing regulations, how can marketers be compliant in those states yet effectively market their products and services? Are there any specific examples you can provide?Answered March 9th, 2009 by Expert:1 commentCurrently, 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.
One response to to “As states institute stricter pharmaceutical marketing regulations, how can marketers be compliant in those states yet effectively market their products and services? Are there any specific examples you can provide?”
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Bill:
Sorry to give you such a tough question so soon after the launch of this great new service. You may have access to company compliance experts to help answer this one. The new PhRMA Code allows companies and reps to give gifts only of educational use/values, including patient education and physician education. Physician education can include both accredited and non-accredited education. But the ACCME’s Standards for Commercial Support (para 4.5, as I recall) prohibits an accredited provider from “using” (allowing) a commercial interest to distribute any of its CME products/services.
So, even though a provider may offer nifty CME programs that cost MDs only $20, it would seem that no company could offer or distribute copies of such programs, or even give docs invitations/BRCs that could authorize physicians to request/receive gifts of those programs directly from the CME provider organization.
So the barrier to giving really good (accredited) educational programs, allowable under the new Code, would seem not to be PhRMA but the ACCME. I wonder if any of the many companies and CME publishers/providers have resolved this “contradiction” and if so, HOW?
Thanks for giving some thought to this paradox,
John WrightJohn, here is Bill’s answer.
Thank you for your follow-up question.
I would say that the “new” PhRMA Code is less burdensome then the Accreditation Council for Continuing Medical Education (ACCME) standards specific to CME programs. However, as I read section 4.5 of the ACCME Standards for Commercial Support, I believe the intention of this section was to prohibit companies that supply commercial support to CMEs from actually being the agent providing access to the CME (i.e. distribution of self-study CMEs, electronic access to a CME event, distribution of CMEs via company owned mediums such as Websites, etc.) Additionally, a company would be prohibited from using CME materials at a promotional visit to a physician’s office.
A company can, however, distribute things like “save the date” cards, brochures, and BRCs to physician offices, thus showing their customers how they are helping to support continuing medical education through independent grants and funding.
I don’t know specifically how companies that provide commercial support and CME providers have resolved this “contradiction” that you state since Cegedim Dendrite does not provide services or guidance within the CME space.
I can say, however, that the PhRMA code does state under section 4 that companies should not provide any subsidy directly to a healthcare practitioner for CME and that all financial support should be provided directly to the CME provider who can use that money to decrease the registration fee of the CME. Additionally, the PhRMA code does state that companies should follow the ACCME Standards for Commercial Support.
In my opinion I don’t see a contradiction, but rather think that the PhRMA code seems to leverage, and is in line with, ACCME’s Standards for Commercial Support.
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