Last week, the city of Chicago commissioner of public health published proposed rules in accordance with a new city ordinance requiring the licensing of pharmaceutical representatives. (For details on the city ordinance please consult our previous client alert here. A link to the proposed rules is available here.
The proposed rules offer some clarification on the scope of individuals considered "pharmaceutical representatives." Specifically excluded are "medical science liaisons," those with advanced science or medical degrees who do not carry out a marketing or sales function, but provide technical assistance to healthcare professionals. Individuals who provide information about pharmaceutical products "solely for the purpose of clinical trials, investigational drugs, or a Risk Evaluation and Mitigation Strategy" are also not considered pharmaceutical representatives under the proposed rules.
While the definition of "pharmaceutical representative" has been somewhat clarified, there are still questions. For example, related industries such as wholesalers and specialty pharmacies may have wanted confirmation that these rules apply only pharma representatives that are affirmatively marketing the benefits of a particular product to prescribers, and not to their employees who call on prescribers for marketing purposes that do not include traditional product detailing activities.
In addition, the proposed rules provided subject areas for coursework to satisfy the continuing education requirements for representatives contained in the ordinance. Pharmaceutical companies who employ or in any way provide compensation to pharmaceutical representatives are prohibited from becoming approved education providers. Representatives who fail to meet these requirements may face fines, license suspension or revocation and potentially "inclusion in a public list of pharmaceutical representatives whose licenses have been revoked."
The proposed rules also indicated that the commissioner of public health will soon provide a format for representatives to submit their required disclosures.