As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and the Commissioner of the Chicago Department of Business Affairs and Consumer Protection (BACP) recently released draft rules related to the license. Comments to the draft rules must be submitted to email@example.com by 11:59pm central time on Sunday, April 2, 2017.
The draft rules provide a number of key details regarding the pharmaceutical sales representative licensure, including the following:
- Licensure Requirement: A pharmaceutical sales representative that conducts business in the City of Chicago for fifteen or more days per calendar year is required to obtain a license. The representative must show the license or an exact copy when contacting a health care professional in person if requested. Excluded from licensure are (i) “Medical Science Liaisons” (or persons with similar titles), defined as “a person with an advanced science or medical degree who provides technical assistance to healthcare professionals and does not carry out a marketing or sales function; and (ii) “Individuals who provide information about a pharmaceutical product solely for the purpose of clinical trials, investigational drugs, or a Risk Evaluation and Mitigation Strategy pursuant to the Federal Food, Drug and Cosmetic Act.
- Education Requirements: Initial applicants must complete an online course that will be available at www.cityofchicago.org/health that will provide an introduction to the pharmaceutical representative license, an overview of the Ordinance’s ethical standards and disclosure requirements, and other topics appropriate to the license. Proof of completion of the online course must accompany the application for the pharmaceutical representative license. Renewal applicants must complete five hours of continuing professional education in one or more of the twelve subject areas enumerated by the Commission. These education requirements are subject to audit and if the requirement has not been met and/or were fraudulently affirmed, the pharmaceutical representative may face license suspension or revocation, inclusion in a public list of pharmaceutical representatives whose licenses have been revoked, and a fine of $1,000 to $3,000 per day of violation. A list of approved courses will be posted on www.cityofchicago.org/health. A pharmaceutical company that employs or in any way provides compensation to any pharmaceutical representative shall not be an approved education provider.
- Disclosure: The Ordinance provided the Commissioner with rulemaking authority to require pharmaceutical representatives to provide certain information regarding his/her interactions with health care professionals to the Commissioner, including a list of health care professionals within the City of Chicago contacted; the number of times the health care professionals were contacted; the location and duration of contact; the pharmaceuticals promoted; whether product samples, materials, or gifts of any value were provided to the health care professional and the value of the products, materials, or gifts; and whether and how the health care professional was compensated for contact with the pharmaceutical representative. The draft rules state that pharmaceutical representatives must provide this information annually at the end of each license period and upon request by the CDPH. The draft rules also state that the information shall be compiled and submitted in a format that will be described on the CDPH website at www.cityofchicago.org/health. However, the draft rules do not provide any specific information regarding the information to be tracked and reported, including the format to be used or when this information will be available from CDPH.
- Ethical Standards: The draft rules provide eight ethical standards that pharmaceutical representatives must follow. These ethical standards generally prohibit deceptive or misleading marketing practices, limit direct patient access and areas reserved for patients, and require compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals.
- Complaints: Health care professionals and patients may file a complaint about a pharmaceutical representative for failure to comply the requirements detailed in the Ordinance or the draft rules by calling 311 or submitting a complaint through the 311 online complaint system. The City will review all complaints and, when warranted, investigate them. Pharmaceutical representatives who violate the Ordinance or draft rules are subject to suspension or revocation of the license and/or a fine of $1,000 to $3,000 per day of violation.
Impacted companies should carefully review the draft rules and consider submitting comments to the CDPH by April 2, 2017.
UPDATE: The final rules adopted by the City of Chicago on June 1, 2017 are available here.