The Chicago City Council recently imposed a number of licensure and marketing requirements on pharmaceutical representatives in Chicago. Beginning on July 1, 2017, individuals who conduct business in the City of Chicago as a pharmaceutical representative for 15 or more days per year must obtain a license, which includes completing an educational course to be determined by the Commissioner of Public Health, submitting a registration form to the Department of Public Health, and paying a $750 licensure fee. Renewal applicants will be required to complete at least five hours of continuing education in the areas of ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing, and other areas that the Commissioner may designate by rule.
The ordinance also includes a number of new disclosure requirements for pharmaceutical representatives. Upon request, or at specific time intervals established by the Commissioner, a pharmaceutical representative must provide the following information to the Commissioner or his or her designee:
- All contacted healthcare professionals within the City of Chicago;
- The number of times such professionals were contacted;
- The location and duration of the contacts;
- All promoted pharmaceuticals;
- The value of product samples, materials, or gifts provided; and
- If and how compensation for a contact was provided.
In addition, there will be yet-to-be determined ethical standards that every pharmaceutical representative will need to follow. Licensed pharmaceutical representatives are also barred from (1) engaging in deceptive marketing, “including the knowing concealment, suppression, omission, misleading representation, or misstatement of any material fact”; (2) using a misleading title to suggest they are licensed to practice medicine or other medical-related profession; or (3) attending patient examinations absent patient consent. Violations can lead to the suspension or revocation of licenses. Penalties can range from $1,000 to $3,000 per offense, and an individual commits a new offense each day in which he or she is not in compliance with the ordinance.
One of the goals of this new ordinance is to help combat an increase in opioid abuse by preventing aggressive and possibly deceptive marketing by pharmaceutical representatives. The new regulatory requirements are expected to raise an estimated $1 million annually that will be utilized to administer the program and help treat addiction.
When navigating new regulations and ordinances, the attorneys at Rock Fusco & Connelly, LLC can help protect you from legal liability.