Kimberly Seay
Associate Editor
Loyola University Chicago School of Law, J.D. 2018
On November 16, 2016, the City Council approved an ordinance amending Chicago Municipal Code § 4-6-010(c)(30), which will require the licensing of all pharmaceutical sales representatives in order to endorse pharmaceuticals within city limits and is set to take effect July 1, 2017. This was passed by the Council in hopes of reducing the rampant prescription of opioids and will require pharmaceutical representatives to undergo training for drug abuse, ethics, marketing regulations, and applicable laws in order to both obtain and annually renew their licenses.
Background
The Mayor has cited “deceptive marketing” as a contributing factor to opioid abuse in Chicago and the ordinance comes as a response to both Mayor Rahm Emanuel and the City’s concerns regarding the increase in opioid abuse within the City and is part of a series of efforts to combat heroin and opioid addiction. Supporters of the ordinance say that marketing from pharmaceutical representatives to medical professionals has led to an excessive prescription of opioids, fueling an epidemic of addiction and overdose. Illinois Attorney General and supporter of the ordinance, Lisa Madigan, has recently filed a lawsuit against the creator of a powerful opioid for directing its sales representatives to promote prescriptions for inappropriate uses that can be both addictive and deadly. The Cook County Medical Examiner’s office released 2015 statistics that showed 609 opioid-related overdose deaths in Cook County occurred, with 403 of those in Chicago. When the ordinance takes effect this summer, Chicago will become one of the only cities in the country with such a requirement. The only other city in the country to require similar licensing is Washington, D.C.
Ordinance Requirements
The ordinance mandates that representatives track all contact with doctors and other healthcare professionals in detail, including drugs discussed, marketing materials handed out, samples and/or materials distributed, whether gifts of any value were provided, the value of those items, and whether doctors received payment for their time. These records may be reviewed by the City upon request at any time or at standard reporting periods established by the Commissioner of Public Health.
Representatives will be required to complete a professional education course, which may not be held by their employer, in order to apply for a license. The licensed representatives will then additionally be required to participate in five hours of annual training, pay an annual $750 licensing fee, and not participate in “deceptive or misleading” marketing of pharmaceutical products. Furthermore, the ordinance will forbid licensed pharmaceutical representatives from using titles or designations that imply they are licensed to practice medicine when they are not able to do so. Violations of the requirements could lead to license suspensions or license revocations for at least two years. Individuals who break the new rules or operate without the required licenses will also be fined between $1,000 and $3,000 for each violation per day. Pharmaceutical representatives who do business in the City of Chicago fewer than fifteen days a year are not required to have the licenses.
What does this mean for pharmaceutical representatives and companies?
It is currently unclear how broadly or narrowly the City will interpret the defined term “pharmaceutical representative.” No matter what, compliance officers working for pharmaceutical companies who employ representatives will need to develop and implement new policies and procedures to ensure they are compliant with the new ordinance. Furthermore, the compliance officer should be sure to create mandatory training and education for employees to help ensure proper recordkeeping. Internal auditing and monitoring by the compliance officers will also be crucial to maintaining compliance with the new ordinance.