Who must obtain a license?
Connecticut now requires manufacturers that employ or compensate sales representatives who market, promote, or provide information on prescription drugs in Connecticut to obtain and renew a manufacturer license annually.
What does the law require for licensed manufacturers?
The initial registration requires manufacturers to provide the state with a list of its pharmaceutical sales representatives. Manufacturers are also required to provide updates to the list, as appropriate, and to restrict any personnel or contractor from marketing on the manufacturer's behalf unless their names are included on the list. This list will be posted publicly on the Department of Consumer Protection website, as will the Department’s annual report on HCP interactions.
Annually, each manufacturer described above must provide the commissioner with information, for each of its listed representatives, including:
the aggregate number of contacts each sales rep had with prescribing practitioners and pharmacists;
the specialty of each practitioner and pharmacist that the sales rep contacted;
whether samples, materials or gifts of any value were provided to a practitioner, pharmacist, or their staff; and
an aggregate report of all free samples by drug name and strength.
What does the law require of pharmaceutical sales representatives engaging with Connecticut HCPs?
Unlike the laws in Nevada, Oregon, D.C., and Chicago, sales representatives are not required to obtain individual licensure in Connecticut. However, they must track information about their interactions with Connecticut prescribing practitioners and pharmacists to allow the manufacturer to submit annual disclosures on the information discussed above. In addition, the law requires sales representatives to disclose, in writing, the list price of a prescription drug discussed with an HCP and information on the variation efficacy of the drug marketed to different racial and ethnic groups, if such information is available. Connecticut’s law does not have continuing education requirements.
What penalties are available under the law?
Entities who engage in prohibited conduct under the law may be subject to license revocation or suspension, restrictive conditions on the license, and/or a civil penalty of up to $1,000 for each violation of the law. Prohibited conduct under the law includes employing individuals to serve as pharmaceutical sales representatives without a license or failure to timely report information required under the law.
How does the Connecticut law compare to similar laws passed in other states?
The law requires registration of manufacturers, which is distinct from the analogous laws in Nevada, Oregon, Washington, D.C., and Chicago that impose requirements on the representatives themselves to obtain licensure and/or track and report transfers of value to HCPs in those states. However, these laws are similar in the additional burden it places on manufacturers (or their representatives, where the manufacturers choose not to assume the responsibility) to monitor various filing deadlines and to prepare and submit annual reports to the states that often overlap with the federal Sunshine reporting requirements. As a refresher, below is a short summary of these laws:
Nevada: The Nevada pharmaceutical sales representative registration law (N.R.S. § 439B.660) requires manufacturers to provide to the Nevada Department of Health and Human Services a list of each pharmaceutical sales representative (including medical science liaisons) who markets prescription drugs to providers of health care, pharmacies, medical facilities, and insurers in Nevada on behalf of the manufacturer, and prohibits such marketing by any person not included on the list. The law also requires each pharmaceutical sales representative included on such a list to submit to the state, by March 1 of each year, a report providing information about their marketing and promotion of prescription drugs to providers in Nevada in the preceding calendar year, including a list of HCPs contacted, compensation provided to HCPs above certain thresholds, and information about free samples. Violations of the licensing law are punishable, for manufacturers, by an administrative penalty of up to $5,000 per day that a manufacturer fails to provide the required list and, for representatives, an administrative penalty of up to $500 per day that the representative fails to comply with the licensing and reporting requirements.
Oregon: The Oregon pharmaceutical representative licensure law (S.B. 763; summarized online here) applies to any person who markets or promotes pharmaceutical products to health care providers in the state of Oregon for at least 15 calendar days per year. The law prohibits such individuals from conducting business as a pharmaceutical representative without obtaining a pharmaceutical representative license. The law also requires licensed pharmaceutical representatives to complete professional education courses and to disclose annually information about their marketing and promotion of pharmaceuticals in the state. Violations of the statute are punishable by suspension or revocation of the license and/or a civil penalty of $1,000 to $3,000 for each day that the violation occurs.
Washington, D.C.: Washington, D.C. has enacted two laws related to pharmaceutical manufacturer marketing conduct in the district:
- The DC AccessRx law (D.C. Code §§ 48-833.01-.09; D.C. Mun. Regs. tit. 22-B, ch. 18) applies to manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in DC. The law requires manufacturers to file a report by July 1 of each year disclosing expenses in the preceding calendar year related to marketing of prescription drugs in DC, with certain exceptions. The annual report must include three separate disclosures: the value, nature, purpose, and recipient of gifts and other specified payments valued over $25 provided to persons and entities licensed to provide health care in DC; all expenses associated with advertising, marketing, and direct promotion of prescription drugs in DC; and the aggregate cost of the manufacturer’s employees or contractors who engage in advertising or promotional activities.
- The DC SafeRx law (D.C. Code §§ 3-1207.41-.45; D.C. Mun. Regs. tit. 17, ch. 83) requires individuals who practice “pharmaceutical detailing” in DC for at least 15 days per year to obtain and hold a pharmaceutical detailer license, with certain limited exceptions for presence in DC related to clinical trials and conferences. The law imposes certain restrictions on licensed pharmaceutical detailers, including continuing education requirements and following certain ethics of practice rules. Violations of the law are punishable by a fine of up to $10,000 in addition to any other penalties available under the general health professions licensing law.
City of Chicago: The City of Chicago’s pharmaceutical representative licensing ordinance (Mun. Code § 4-6-310) applies to any person who markets or promotes pharmaceuticals to health care professionals (including physicians or others licensed to provide health care services or prescribe drugs, but excluding medial science liaisons) in the city of Chicago for at least 15 calendar days per year. The law prohibits such individuals from conducting business as a pharmaceutical representative without obtaining a pharmaceutical representative license. The law also requires licensed pharmaceutical representatives to comply with specified ethical standards and to disclose, upon request by the city’s Department of Public Health, information about their marketing and promotion of Schedule II medications in the city of Chicago.
We will continue to monitor the rollout of Connecticut HB6669, and keep you apprised of any changes to this and other related state laws. If you have any questions about this new legislation, or on pharmaceutical sales representative reporting requirements more generally, feel free to contact any of the authors of this alert or the Hogan Lovells attorney with whom you usually work.